| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K014142 |
12/17/2001 |
UNITE BONDING ADHESIVE |
3M UNITEK |
L. MARLYN SCHEFF |
| K010510 |
02/21/2001 |
BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1 |
A & A MEDICAL, INC. |
JIHAD (JAY) MANSOUR |
| K014201 |
12/21/2001 |
AARON REUSABLE ELECTROSURGICAL ELECTRODE |
AARON MEDICAL INDUSTRIES |
RICHARD A KOZLOFF |
| K010363 |
02/07/2001 |
ETEST MEROPENEM |
AB BIODISK |
ANNE BOLMSTROM |
| K010553 |
02/26/2001 |
PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY |
ABBOTT LABORATORIES |
JANET CONNOLLY |
| K014118 |
12/14/2001 |
MODIFICATION TO SUPERCROSS CATHETER |
ABBOTT VASCULAR INC. |
SEVRINA CIUCCI |
| K014203 |
12/21/2001 |
ABX MICROS 60 HEMATOLOGY ANALYZER |
ABX DIAGNOSTICS |
TOM M PHILLIPS |
| K010390 |
02/09/2001 |
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS |
ACIST MEDICAL SYSTEMS, INC. |
CARL M BEAURLINE |
| K013972 |
12/03/2001 |
H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005 |
ACKARD LABORATORIES |
RICHARD HETTENBACH |
| K010582 |
02/27/2001 |
ACON STREP A RAPID TEST STRIP |
ACON LABORATORIES CO. |
ROBERT HUDAK |
| K010587 |
02/27/2001 |
ACTIVEECG |
ACTIVE CORP. |
KAREN SIEGEL |
| K014185 |
12/20/2001 |
AOS CANNULATED BONE SCREW SYSTEM |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
PAUL DONER |
| K013987 |
12/04/2001 |
REPROCESSED DISPOSABLE TROCARS |
ADVEN MEDICAL |
MARK W ALDANA |
| K014172 |
12/20/2001 |
NELSON ELECTROSURGICAL UNIT, MODEL GN640 |
AESCULAP, INC. |
LISA MILLINGTON |
| K014149 |
12/18/2001 |
PAEDISCOPE, MODEL # P010A AND PF011A |
AESCULAP, INC. |
GEORG KELLER |
| K014207 |
12/21/2001 |
REPOSABLE INSTRUMENT SYSTEM, MODELS MF001-MF083 |
AESCULAP, INC. |
LISA MILLINGTON |
| K014144 |
12/18/2001 |
EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804 |
AFP IMAGING CORP. |
DAVID VOZICK |
| K010571 |
02/26/2001 |
ADC QS/IPD WORKSTATION |
AGFA CORP. |
T. WHIT ATHEY |
| K010453 |
02/15/2001 |
M2376A DEVICELINK SYSTEM |
AGILENT TECHNOLOGIES, INC. |
MIKE HUDON |
| K010342 |
02/05/2001 |
M2376A DEVICELINK SYSTEM, MODEL M2376A |
AGILENT TECHNOLOGIES, INC. |
MIKE HUDON |
| K014081 |
12/11/2001 |
AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGES |
AKTINA MEDICAL PHYSICS CORP. |
JOAN KACHAROPOULOS |
| K014202 |
12/21/2001 |
COMPLETE BRAND MULTI-PURPOSE SOLUTION |
ALLERGAN, INC. |
PAUL J NOWACKI |
| K014071 |
12/10/2001 |
PMX DISPOSABLE BAG MASK RESUSCITATOR |
ALLIED HEALTHCARE PRODUCTS, INC. |
VERNON TRIMBLE |
| K014241 |
12/26/2001 |
COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D |
ALSIUS CORP. |
KEN COLLINS |
| K014040 |
12/07/2001 |
FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE I, II AND FUTURE MODELS |
ALTUS MEDICAL, INC. |
KATHY MAYNOR |
| K010583 |
02/27/2001 |
AMBU GEL, HYDROGEL BURN DRESSING |
AMBU, INC. |
SANJAY PARIKH |
| K014101 |
12/13/2001 |
RAPIDONE-OXY TEST |
AMERICAN BIO MEDICA CORP. |
HENRY WELLS |
| K010503 |
02/21/2001 |
AMIGO WHEELCHAIR |
AMIGO MOBILITY INTL., INC. |
MIKE LABRAKE |
| K010605 |
02/28/2001 |
ATLAST DATA MANAGEMENT SOFTWARE (DMS) |
AMIRA MEDICAL, INC. |
NINA PELED |
| K014023 |
12/06/2001 |
BABY TEETHER, MODEL 20104 |
ANGELINA TRADING, INC. |
JOHN CHANG |
| K010544 |
02/23/2001 |
VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE |
APEX DENTAL MATERIALS, INC. |
SCOTT LAMERAND |
| K010547 |
02/23/2001 |
VERTEX SEALAND L/C ORTHODONTIC SEALANT |
APEX DENTAL MATERIALS, INC. |
SCOTT LAMERAND |
| K014005 |
12/05/2001 |
APPLE MEDICAL MOBIUS ELASTIC RETRACTOR |
APPLE MEDICAL CORP. |
JOHN C PULFORD |
| K014047 |
12/07/2001 |
APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE |
APPLIED MEDICAL RESOURCES CORP. |
ANIL BHALANI |
| K010592 |
02/28/2001 |
AQUA WATER TREATMENT FOR HEMODIALYSIS |
AQUA WATER TREATMENT, INC. |
ANTHONY WEATHERS |
| K010330 |
02/02/2001 |
ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U |
ARROW INTL., INC. |
WILLIAM PAQUIN |
| K010525 |
02/22/2001 |
ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM |
ARTHREX, INC. |
VERNON BROWN |
| K010457 |
02/16/2001 |
ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-1924 |
ARTHREX, INC. |
VERNON BROWN |
| K014155 |
12/19/2001 |
OPENING/CLOSING WEDGE OSTETOMY PLATES |
ARTHREX, INC. |
ANN WATERHOUSE |
| K014222 |
12/26/2001 |
ARTHROCARE CONTROLLER, PATIENT CABLE, FOOT CONTROL, POWER CORD |
ARTHROCARE CORP. |
BRUCE PROTHRO |
| K010568 |
02/26/2001 |
ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM |
ARTHROCARE CORP. |
BETTY M JOHNSON |
| K014290 |
12/28/2001 |
ENTEC PLASMA WANDS |
ARTHROCARE CORP. |
BRUCE PROTHRO |
| K014305 |
12/31/2001 |
RESORBABLE LACTOSORB-L ACL CROSSPIN |
ARTHROTEK, INC. |
SARA B SHULTZ |
| K014057 |
12/10/2001 |
DERMASTAR ER:YAG LASER SYSTEM |
ASCLEPION-MEDITEC AG |
WILLIAM KELLEY |
| K010514 |
02/21/2001 |
BREASTVIEW VISUAL MAPPING SYSTEM |
ASSURANCE MEDICAL |
HOWARD M HOLSTEIN |
| K010473 |
02/20/2001 |
SPARROWHAWK DISPOSABLE |
ATC TECHNOLOGIES, INC. |
PAUL KIERCE |
| K014102 |
12/13/2001 |
PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251 |
ATOS MEDICAL AB |
EDDY ABERG |
| K010517 |
02/22/2001 |
ADVANTA SST GRAFT (<6MM) |
ATRIUM MEDICAL CORP. |
KAREN HALL |
| K010516 |
02/22/2001 |
ADVANTA SST GRAFT (>_6MM) |
ATRIUM MEDICAL CORP. |
KAREN HALL |
| K010477 |
02/20/2001 |
AUTO-LOCK |
AUTO-LOCK |
DIETRICH W GRABIS |
| K014210 |
12/21/2001 |
PALMO THERMOREGULATION INTERFACE ACCESSORY |
AVACORE TECHNOLOGIES, INC. |
CRAIG COOMBS |
| K014246 |
12/26/2001 |
AVID-NIT NERVE STIMULATION NEEDLES |
AVID N.I.T., INC. |
SCOTT HENDERSON |
| K010462 |
02/16/2001 |
AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) |
AVITA CORPORATION |
ALLEN REICH |
| K010485 |
02/20/2001 |
VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER |
B BRAUN |
PAUL O'CONNELL |
| K014174 |
12/20/2001 |
HARVEY PV DRY STERILIZER, MODEL # ST127325; ST127320; ST127320-33 |
BARNSTEAD/THERMOLYNE CORP. |
MIA M WARE |
| K010566 |
02/26/2001 |
COLLEAGUE VOLUMETRIC INFUSION PUMP |
BAXTER HEALTHCARE CORP. |
JENNIFER M PAINE |
| K014088 |
12/12/2001 |
DUPLOREACH |
BAXTER HEALTHCARE CORP. |
ARLENE VIDOR |
| K014075 |
12/11/2001 |
BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145 |
BAYLIS MEDICAL CO., INC. |
KRIS SHAH |
| K010429 |
02/13/2001 |
ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345 |
BECKMAN COULTER, INC. |
BRENT TABER |
| K010428 |
02/13/2001 |
ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349 |
BECKMAN COULTER, INC. |
BRENT TABER |
| K014034 |
12/07/2001 |
MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) |
BECKMAN COULTER, INC. |
ANNETTE HELLIE |
| K013978 |
12/03/2001 |
SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT |
BECKMAN COULTER, INC. |
MARY BETH TANG |
| K010597 |
02/28/2001 |
SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT |
BECKMAN COULTER, INC. |
ANNETTE HELLIE |
| K014103 |
12/13/2001 |
SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR |
BECKMAN COULTER, INC. |
MARY BETH TANG |
| K014173 |
12/20/2001 |
SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR |
BECKMAN COULTER, INC. |
MARY BETH TANG |
| K010358 |
02/06/2001 |
VIGIL SEROLOGY CONTROL LEVEL C |
BECKMAN COULTER, INC. |
ANNETTE HELLIE |
| K013971 |
12/03/2001 |
BD VACUTAINER SAFETY COAGULATION TUBE |
BECTON DICKINSON & CO. |
KEITH SMITH |
| K010572 |
02/26/2001 |
BD VISIDRAPE OPHTHALMIC DRAPES; BD VISIFLEX INCISE DRAPE |
BECTON DICKINSON AND CO. |
JAMES STAFFIERA |
| K014123 |
12/17/2001 |
BACTEC MGIT 960 SIRE KITS |
BECTON, DICKINSON & CO. |
JODY J HOFFMANN |
| K010523 |
02/22/2001 |
MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST |
BINAX, INC. |
PAMELA S ANGELL |
| K014019 |
12/06/2001 |
NEUROTECH MEDISTIM PLUS, TYPE 291 |
BIO-MEDICAL RESEARCH, LTD. |
MICHELLE SAWYER |
| K014020 |
12/06/2001 |
NT MEDITENS PLUS, TYPE 290 |
BIO-MEDICAL RESEARCH, LTD. |
MICHELLE SAWYER |
| K010335 |
02/02/2001 |
SLENDERTONE FLEX, MODEL, 512 |
BIO-MEDICAL RESEARCH, LTD. |
ROBERT DORMER |
| K010458 |
02/16/2001 |
THE MAESTRO SYSTEM |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
STEVEN BOGGAN |
| K010550 |
02/26/2001 |
VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428 |
BIOMERIEUX, INC. |
Nancy Weaver |
| K020870 |
12/28/2001 |
VITEK 2 ANTIMICROBIAL SUSCEPTIBILITY TEST SYTEM FOR SPARFLOXACIN |
BIOMERIEUX, INC. |
Nancy Weaver |
| K020871 |
12/28/2001 |
VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN |
BIOMERIEUX, INC. |
Nancy Weaver |
| K010560 |
02/26/2001 |
PORTRAIT FEMORAL COMPONENT |
BIOMET, INC. |
MICHELLE L MCKINLEY |
| K010348 |
02/05/2001 |
TANTALUM BEADS - RADIOGRAPHIC MARKER |
BIOMET, INC. |
LONNIE WITHAM |
| K010554 |
02/26/2001 |
MENISCUS ARROW SHEATH #CN1000A; SMARTSCREW ACL SHEATH #SSA2000A |
BIONX IMPLANTS, INC. |
TUIJA ANNALA |
| K014247 |
12/26/2001 |
TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002 |
BIOSITE INCORPORATED |
JEFFREY R DAHLEN |
| K010405 |
02/12/2001 |
7230 ULTRASOUND IMAGING SYSTEM WITH TEI |
BIOSOUND ESAOTE, INC. |
COLLEEN HITTLE |
| K014168 |
12/19/2001 |
AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION) |
BIOSOUND ESAOTE, INC. |
COLLEEN H DENSMORE |
| K014000 |
12/04/2001 |
VISTITOME 20-10 MICROKERATOME |
BIOVISION AG |
DAVID S FERNQUIST |
| K014169 |
12/19/2001 |
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS |
BOB J. JOHNSON & ASSOC., INC |
ROBERT SNYDER |
| K014187 |
12/21/2001 |
AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM |
BOEHRINGER LABORATORIES |
JOHN KARPOWICZ |
| K013976 |
12/03/2001 |
BOEHRINGER MRI SUCTION REGULATORY |
BOEHRINGER LABORATORIES |
JOHN KARPOWICZ |
| K010479 |
02/20/2001 |
MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR |
BONUTTI RESEARCH, INC. |
PATRICK BALSMANN |
| K014297 |
12/31/2001 |
ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT; ENDOVIVE LOW PROFILE BUTTON REPLACEMENT GASTROSTOMY TUBE; SECURI-T INITIAL P |
BOSTON SCIENTIFIC CORP. |
PAIGE SWEENEY |
| K014195 |
12/21/2001 |
KAYAK HYDROPHILIC GUIDE WIRES |
BOSTON SCIENTIFIC CORP. |
MARK MURPHY |
| K014109 |
12/14/2001 |
IN-TIME RETRIEVAL DEVICE |
BOSTON SCIENTIFIC, TARGET |
SETH A SCHULMAN |
| K014256 |
12/26/2001 |
KOLIBRI IGS SYSTEMS |
BRAINLAB AG |
STEFAN VILSMEIER |
| K010602 |
02/28/2001 |
VECTORVISION HIP |
BRAINLAB, AG |
RAINER BIRKENBACH |
| K010505 |
02/21/2001 |
TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY |
BRENTWOOD MEDICAL TECHNOLOGY CORP. |
RUOMEI ZHANG |
| K014280 |
12/27/2001 |
LATEX EXAMINATION GLOVE (POWDERED) |
BRIGHTWAY GLOVES PVT. LTD. |
N. PARAMASIVAN |
| K014279 |
12/27/2001 |
LATEX EXAMINATION GLOVES (POWDER FREE) |
BRIGHTWAY GLOVES PVT. LTD. |
N. PARAMASIVAN |
| K014283 |
12/27/2001 |
LATEX SURGEONS GLOVE (POWDER FREE) |
BRIGHTWAY GLOVES PVT. LTD. |
N. PARAMASIVAN |
| K014278 |
12/27/2001 |
LATEX SURGEONS GLOVE (POWDERED) |
BRIGHTWAY GLOVES PVT. LTD. |
N. PARAMASIVAN |
| K010343 |
02/05/2001 |
BMR DENTAL IMPLANT SYSTEM, MODEL 3.3XX, EITHER HA OR TPS COATED, 3.308, 3.310,3.312, 3.314 3.316 |
BUCK MEDICAL RESEARCH |
REBECCA ELLIS |
| K010444 |
02/14/2001 |
ADVANTAGE SINGLE-USE ELECTROSURGICAL ATTACHMENT-J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, BALL TIP, NEEDLE TIP |
C.R. BARD, INC. |
KERRY CHUNKO |
| K014212 |
12/21/2001 |
BARD CONQUEST PTA BALLOON DILATATION CATHETER |
C.R. BARD, INC. |
CAROL VIERLING |
| K010567 |
02/26/2001 |
OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR |
C.R. BARD, INC. |
PEGGY KEIFFER |
| K014128 |
12/17/2001 |
CANDELA SMOOTHBEAM LASER SYSTEM |
CANDELA CORP. |
LORRAINE NELSON |
| K010552 |
02/26/2001 |
CG-900P FETAL/MATERNAL MONITOR |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
LEONID TRACHTENBERG |
| K010396 |
02/09/2001 |
C. NET 2100 |
CARDIONETICS, LTD. |
BARRY SALL |
| K010393 |
02/08/2001 |
APOLLO MOBILE C ARM SYSTEM |
CARES BUILT, INC. |
TIMOTHY TELYMONDE |
| K010392 |
02/08/2001 |
ATHENA REMOTE CONTROLLED RF SYSTEM |
CARES BUILT, INC. |
TIMOTHY TELYMONDE |
| K010391 |
02/09/2001 |
ATLAS MULTI-PURPOSE DSA SYSTEM |
CARES BUILT, INC. |
TIMOTHY TELYMONDE |
| K014028 |
12/06/2001 |
CARESIDE APTT |
CARESIDE HEMOTOLOGY, INC. |
KENNETH B ASARCH |
| K010349 |
02/05/2001 |
DUAL LUMEN MIDLINE CATHETER |
CATHETER INNOVATIONS, INC. |
ROGER L RICHINS |
| K013960 |
12/03/2001 |
APATIGHT HA-BONE GRAFT SUBSTITUTE |
CERABIO, LLC |
JAMES J CASSIDY |
| K013966 |
12/03/2001 |
APATIGHT-TCP BONE GRAFT SUBSTITUTE |
CERABIO, LLC |
JAMES J CASSIDY |
| K010389 |
02/09/2001 |
CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411 |
CHAD THERAPEUTICS, INC. |
KEVIN MCCULLOH |
| K014048 |
12/07/2001 |
CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS |
CLINICON CORP. |
SEAN M CURRY |
| K014236 |
12/26/2001 |
CLINICON WAVEGUIDE PLATFORM WITH INTERCONNECT FOR LUXAR ACCESSORIES |
CLINICON CORP. |
SEAN M CURRY |
| K014063 |
12/11/2001 |
TASK FORCE MONITOR 3040 |
CNSYSTEMS MEDIZINTECHNIK GMBH |
CHRISTIAN WAGNER |
| K014153 |
12/18/2001 |
COAPT SYSTMES ENDOTINE DEVICE |
COAPT SYSTEMS, INC. |
JUDE PAGANELLI |
| K014234 |
12/26/2001 |
MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER |
CONTINUUM ELECTRO-OPTICS, INC. |
RONALD KOHLHARDT |
| K014160 |
12/19/2001 |
PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES) |
COOK UROLOGICAL, INC. |
DEBBIE SCHMITT |
| K010601 |
02/28/2001 |
FANELLI BILIARY STENT |
COOK, INC. |
LISA HOPKINS |
| K010450 |
02/15/2001 |
LIVER TAMPONADE BALLOON |
COOK, INC. |
LISA HOPKINS |
| K014035 |
12/07/2001 |
COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS |
COOLTOUCH CORP. |
DONALD V JOHNSON |
| K010316 |
02/02/2001 |
COOLTOUCH VARIA ND:YAG LASER SYSTEM; COOLTOUCH VARIA-II ND:YAG LASER SYSTEM |
COOLTOUCH CORP. |
DONALD V JOHNSON |
| K010411 |
02/12/2001 |
PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM |
CORDIS CORP. |
CHARLES J RYAN |
| K010445 |
02/14/2001 |
PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM |
CORDIS CORP. |
SAM MIRZA |
| K014041 |
12/07/2001 |
TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM |
CORDIS NEUROVASCULAR |
ALINA CARABALLO |
| K010511 |
02/21/2001 |
MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES |
CORDIS NEUROVASCULAR, INC. |
Amarilys Machado |
| K014262 |
12/27/2001 |
COSMED QUARK C12/QUARK T12 |
COSMED S.R.L. |
ROBERT SCHIFF |
| K013975 |
12/03/2001 |
CP-SLEEVE |
CP MEDICAL |
MARY ANN GREENWALT |
| K013964 |
12/03/2001 |
MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS |
CP MEDICAL |
MARY ANN GREENWALT |
| K014012 |
12/05/2001 |
DOC BAND |
CRANIAL TECHNOLOGIES, INC. |
TIMOTHY R LITTLEFIELD |
| K014156 |
12/19/2001 |
CERASORB ORTHO |
CURASAN AG |
ERIC WIECHERT |
| K014216 |
12/21/2001 |
SECCA SYSTEM |
CURON MEDICAL, INC. |
JONATHAN S KAHAN |
| K010314 |
02/02/2001 |
DIMENSION CTNI CALIBRATOR |
DADE BEHRING, INC. |
GEORGE PLUMMER |
| K010313 |
02/02/2001 |
DIMENSION CTNI FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
GEORGE PLUMMER |
| K010418 |
02/12/2001 |
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS |
DADE BEHRING, INC. |
CYNTHIA VAN DUKER |
| K010494 |
02/20/2001 |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 |
DADE BEHRING, INC. |
RADAMES RIESGO |
| K010395 |
02/09/2001 |
E-POWER |
DALTON MEDICAL CORP. |
WILL RIDGWAY |
| K010463 |
02/16/2001 |
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES |
DATEX-OHMEDA, INC. |
JOEL C KENT |
| K014238 |
12/26/2001 |
DELSONIC 2000 |
DELDENT LTD. |
ALAN EDEL |
| K014249 |
12/26/2001 |
JETPOLISHER |
DELDENT LTD. |
ALAN EDEL |
| K014245 |
12/26/2001 |
JETSONIC 2000 |
DELDENT LTD. |
ALAN EDEL |
| K014252 |
12/26/2001 |
JETSTREAM |
DELDENT LTD. |
ALAN EDEL |
| K013969 |
12/03/2001 |
MINIBLASTER |
DELDENT LTD. |
ALAN EDEL |
| K014188 |
12/21/2001 |
NEW PROPHY POWDER |
DENTSPLY INTL. |
P. JEFFERY LEHN |
| K014053 |
12/10/2001 |
CONDUIT TCP GRANULES |
DEPUY ACROMED |
KAREN F JURCZAK |
| K010320 |
02/02/2001 |
MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM |
DEPUY ACROMED |
KAREN F JURCZAK |
| K010576 |
02/27/2001 |
MONARCH SPINE SYSTEM |
DEPUY ACROMED |
FRANK MAAS |
| K010367 |
02/07/2001 |
MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM |
DEPUY ORTHOPAEDICS, INC. |
ARLENE C SAULL |
| K013984 |
12/03/2001 |
IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K010350 |
02/05/2001 |
STA -CALIBRATOR HBPM/LMWH KIT |
DIAGNOSTICA STAGO, INC. |
ANDREW LOC B. LE |
| K010324 |
02/02/2001 |
STA-QUALITY HBPM/LMWH KIT |
DIAGNOSTICA STAGO, INC. |
ANDREW LOC B. LE |
| K014120 |
12/17/2001 |
TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) |
DIAGNOSTICS BIOCHEM CANADA, INC. |
G. R. DUMONT |
| K014030 |
12/06/2001 |
1,25-DIHYDROXYVITAMIN D125I RIA |
DIASORIN, INC. |
DAVID IKEDA |
| K010399 |
02/09/2001 |
DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM) |
DIATEK, INC. |
TODD CASSIDY |
| K010478 |
02/20/2001 |
DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR |
DIDECO |
LYNNE LEONARD |
| K014080 |
12/11/2001 |
APEX ADULT HOLLOWE FIBER OXYGENATOR |
DIDECO S.P.A. |
BARRY S SALL |
| K014141 |
12/17/2001 |
DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11 |
DIGIBIO TECHNOLOGY CORP. |
ERIC LUO |
| K014072 |
12/10/2001 |
FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH) |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
JONATHAN S KAHAN |
| K010595 |
02/28/2001 |
DJ ORTHOPEDICS INTERFERENCE SCREW |
DJ ORTHOPEDICS, LLC |
JAMAL D RUSHDY |
| K010594 |
02/28/2001 |
DJ ORTHOPEDICS POST SCREW |
DJ ORTHOPEDICS, LLC |
JAMAL D RUSHDY |
| K014218 |
12/21/2001 |
OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210' |
DOLPHIN MEDICAL INC. |
JON WERNER |
| K010386 |
02/08/2001 |
DUO-DENT DENTAL IMPLANT |
DUO-DENT DENTAL IMPLANT SYSTEMS LLC. |
MICHAEL H VOVOLKA |
| K010565 |
02/26/2001 |
DYNATRON STS |
DYNATRONICS CORP. |
JOHN S RAMEY |
| K010551 |
02/26/2001 |
EBI DYNAFIX VS OSTEOTOMY SYSTEM |
EBI, L.P. |
PATRICIA FLOOD |
| K014137 |
12/17/2001 |
MODIFICATION TO EBI OMEGA 21 SYSTEM |
EBI, L.P. |
FREDERIC TESTA |
| K010437 |
02/13/2001 |
MODIFICATION TO EBI XFIX DFS RAIL SYSTEM |
EBI, L.P. |
PATRICIA FLOOD |
| K014276 |
12/27/2001 |
MODIFICATION TO EBI XFIX DFS SYSTEM |
EBI, L.P. |
FREDERIC TESTA |
| K014194 |
12/21/2001 |
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM |
EBI, L.P. |
PATRICIA M FLOOD |
| K010482 |
02/20/2001 |
ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1 |
ECHOCATH, INC. |
DAVID LYONS |
| K014052 |
12/10/2001 |
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL |
EDWARDS LIFESCIENCES, LLC. |
JASON SMITH |
| K014054 |
12/10/2001 |
EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL |
EDWARDS LIFESCIENCES, LLC. |
JASON SMITH |
| K013990 |
12/03/2001 |
LIFESTITCH SUTURING DEVICE |
EDWARDS LIFESCIENCES, LLC. |
LUCINDA STOCKERT |
| K010488 |
02/20/2001 |
ATAC PAK AST REAGENT KIT |
ELAN HOLDINGS, INC. |
WYNN STOCKING |
| K010526 |
02/22/2001 |
MODIFICATION TO THE GRIP |
ELCARE INNOVATIONS, INC. |
ELROY T CANTRELL |
| K010465 |
02/16/2001 |
DENSTAT |
ELMED, INC. |
WERNER HAUSNER |
| K014107 |
12/13/2001 |
ENDIUS CERVICAL PLATE SYSTEM |
ENDIUS, INC. |
GENE DIPOTO |
| K014090 |
12/11/2001 |
ENDIUS SPINAL FIXATION SYSTEM |
ENDIUS, INC. |
GENE DIPOTO |
| K010535 |
02/23/2001 |
TRIFIX SPINAL FIXATION SYSTEM |
ENDIUS, INC. |
SUSAN FINNERAN |
| K010339 |
02/05/2001 |
ENDOCARE PERCUTANEOUS ACCESS SET |
ENDOCARE, INC. |
VINCENT CUTARELLI |
| K010356 |
02/05/2001 |
LATEX EXAMINATION GLOVES-POWDER FREE |
ENZYMIC TECHNOLOGIES SDN BHD |
LEE HONG YEN |
| K010347 |
02/05/2001 |
LATEX EXAMINATION GLOVES-POWDERED, NONSTERILE |
ENZYMIC TECHNOLOGIES SDN BHD |
LEE HONG YEN |
| K010311 |
02/01/2001 |
LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICE |
EUROMI SA |
JOSEPH M AZARY |
| K010434 |
02/13/2001 |
OPTETRAK B-SERIES TOTAL KNEE SYSTEM |
EXACTECH, INC. |
Lisa Simpson |
| K010404 |
02/12/2001 |
EXEL I.V. ADMINISTRATION SET |
EXELINT INTL. CO. |
ARMAND HAMID |
| K010562 |
02/26/2001 |
ALPHA DX SYSTEM |
FIRST MEDICAL, INC. |
GREG HOLLAND |
| K014024 |
12/06/2001 |
MODIFICATION TO ALPHA DX SYSTEM |
FIRST MEDICAL, INC. |
GREG HOLLAND |
| K013977 |
12/03/2001 |
ECHO-SCREEN T, TA, TD, TDA, TC |
FISCHER-ZOTH AUDIOLOGIC SYSTEMS, INC. |
MICHAEL SOERENSEN |
| K014284 |
12/27/2001 |
NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE AND YELLOWISH WHITE |
FORMOSA GLOVE INDUSTRIAL CO., LTD. |
TIANG S CHANG |
| K014285 |
12/27/2001 |
NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE, PURPLE |
FORMOSA GLOVE INDUSTRIAL CO., LTD. |
TIANG S CHANG |
| K014002 |
12/04/2001 |
ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 |
FORTUNE MEDICAL INSTRUMENT CORP. |
ABE WANG |
| K013997 |
12/04/2001 |
UNIFIL BOND |
GC AMERICA, INC. |
TERRY L JORITZ |
| K014097 |
12/12/2001 |
GE LOGIQ 5 |
GE MEDICAL SYSTEMS |
ALLEN SCHUH |
| K014255 |
12/26/2001 |
DINAMAP PROCARE SERIES MONITOR; MODEL 100, 200, 300, 400 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
THOMAS ENGLISH |
| K010336 |
02/05/2001 |
ADVANTAGE WINDOWS CT/PET FUSION |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
| K014289 |
12/28/2001 |
ORTHOSS RESORBABLE BONE VOID FILLER |
GEISTLICH-PHARMA |
PETER S REICHERTZ |
| K010301 |
02/01/2001 |
IMMUNOWELL EA (D) IGG TEST |
GenBio |
Bryan Kiehl |
| K010329 |
02/02/2001 |
LOGIQ 500 |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K014206 |
12/21/2001 |
LOGIQBOOK |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K014058 |
12/10/2001 |
ENTEGRA PE PERSONAL DIGITAL ASSISTANT |
GENERAL ELECTRIC MEDICAL SYSTEMS |
D. DUERSTELER |
| K014108 |
12/13/2001 |
MAC 5000 ECG ANALYSIS SYSTEM |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
LISA LEE MICHELS |
| K010312 |
02/01/2001 |
GIVEN DIAGNOSTIC IMAGING SYSTEM |
GIVEN IMAGING LTD. |
SHOSHANA FRIEDMAN |
| K014104 |
12/13/2001 |
VACUETTE EDTA K2 TUBES |
GREINER VACUETTE NORTH AMERICA, INC. |
Judi Smith |
| K014250 |
12/26/2001 |
7MM EXTENDED LENGTH ENDOSCOPE,DISSECTION TIPS, MODELS VH-1111, VH-1114 |
GUIDANT CORP. |
ANNE SCHLAGENHAFT |
| K014007 |
12/05/2001 |
DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM |
GUIDANT CORP. |
SABA MODJARRAD |
| K014184 |
12/20/2001 |
MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM |
GUIDANT CORP. |
SABA MODJARRAD |
| K014013 |
12/05/2001 |
H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM |
H & W TECHNOLOGY, LLC |
CHARLES O HANCOCK |
| K014083 |
12/11/2001 |
HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM |
HAEMONETICS CORP. |
JOHN SOKOLOWSKI |
| K014164 |
12/19/2001 |
GREAT TOE IMPLANT SYSTEM |
HARMOS ORTHOPAEDICS, INC. |
RICHARD W WOODS |
| K010425 |
02/13/2001 |
EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY) |
HDC CORP. |
EARL SMART |
| K014122 |
12/17/2001 |
HL168E |
HEALTH & LIFE CO., LTD. |
SUSAN CHEN |
| K010577 |
02/27/2001 |
BODYGEM, MODEL HB211 |
HEALTHETECH, INC. |
NOEL L JOHNSON |
| K010442 |
02/14/2001 |
KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652 |
HEINZ KURZ |
DAGMAR S MASER |
| K010541 |
02/23/2001 |
PREVISION CHEM |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
| K014094 |
12/12/2001 |
MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM |
HILL-ROM MANUFACTURING, INC. |
CINDY L CROSBY |
| K014240 |
12/26/2001 |
PRONTO |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
ROBERT MCCARTHY |
| K014074 |
12/10/2001 |
HOFFRICHTER VECTOR, VECTOR PLUS, VECTOR BI-VEVEL, VECTOR BI-LEVEL PLUS, SCALAR, SCALAR PLUS; CPAP WITH HUMIDIFIER OPTION |
HOFFRICHTER GMBH |
STEPHEN H GORSKI |
| K010403 |
02/12/2001 |
PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700, 563700 |
HOME DIAGNOSTICS, INC. |
KAREN DEVINCENT |
| K014025 |
12/06/2001 |
HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READER |
HOMMED LLC. |
TOMMIE J MORGAN |
| K010448 |
02/15/2001 |
HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES |
HORIZONS INTL. CORP. |
RAFIC SALEH |
| K014229 |
12/26/2001 |
MODIFICATION TO OPUS SPINAL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K010310 |
02/01/2001 |
MODIFICATION TO TRIDENT ALL POLY CUP |
HOWMEDICA OSTEONICS CORP. |
JENNIFER A DAUDELIN |
| K014199 |
12/21/2001 |
SURGICAL SIMPLEX P WITH TOBRAMYCIN |
HOWMEDICA OSTEONICS CORP. |
WILLIAM J CYMBALUK |
| K014220 |
12/26/2001 |
T2 FEMORAL NAIL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K014226 |
12/26/2001 |
UNITRAX MODULAR UNIPOLAR SYSTEM |
HOWMEDICA OSTEONICS CORP. |
JENNIFER A DAUDELIN |
| K010402 |
02/12/2001 |
SMOOTH-FLO CIRCUIT |
HUDSON RESPIRATORY CARE, INC. |
CHARLES MIERKIEWICZ |
| K014022 |
12/06/2001 |
MRI LINE MARKER |
I.Z.I. CORP. |
HELEN ZINREICH |
| K014130 |
12/17/2001 |
NLITE SYSTEM |
ICN PHOTONICS LTD. |
IAN MORTIMER |
| K014018 |
12/06/2001 |
CHOLESTEROL 1, 2, 3 |
IMI |
THOMAS M TSAKERIS |
| K014235 |
12/26/2001 |
OSSEOTITE NT DENTAL IMPLANTS & ACCESSORIES |
IMPLANT INNOVATIONS, INC. |
JEANNETTE G DAILEY |
| K010378 |
02/08/2001 |
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ |
IMPLEX CORP. |
JOHN SCHALAGO |
| K010352 |
02/06/2001 |
CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM |
INION LTD. |
HANNA MARTTILA |
| K010351 |
02/06/2001 |
INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM |
INION LTD. |
HANNA MARTTILA |
| K010533 |
02/23/2001 |
BIOSLING - BIOABSORBABLE POLYMER SLING & SURGICAL MESH |
INJECTX, INC. |
ASHVIN DESAI |
| K010422 |
02/12/2001 |
ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER |
INNERSPACE, INC. |
DONALD E BOBO |
| K010558 |
02/26/2001 |
QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K010520 |
02/22/2001 |
GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS |
INSTRUMENTATION LABORATORY CO. |
REBA POIRIER |
| K010379 |
02/08/2001 |
IL TEST FREE PROTEIN S |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K014239 |
12/26/2001 |
MEDSURG EQUIPMENT COVERS |
INTERNATIONAL MEDSURG CONNECTION |
MICHELE H VOVOLKA |
| K010599 |
02/28/2001 |
PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE |
INTERNATIONAL TECHNIDYNE CORP. |
JOHN CLAY |
| K010530 |
02/23/2001 |
GEO STRUCTURE |
INTERPORE CROSS INTL. |
LYNN M RODARTI |
| K010515 |
02/22/2001 |
MODIFICATION TO SYNERGY SPINAL SYSTEM |
INTERPORE CROSS INTL. |
LYNN M RODARTI |
| K014145 |
12/18/2001 |
MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODEL 8130, 8131 |
INTERPORE CROSS INTL. |
LYNN M RODARTI |
| K010531 |
02/23/2001 |
ILT DEFLECTING CATHETER, MODEL C114ND1 |
INTRALUMINAL THERAPEUTICS, INC. |
PAMELA MISAJON |
| K010364 |
02/07/2001 |
MCC-MIV ONE 2 ONE SOFTWARE |
INVACARE CORP. |
RAE ANN FARROW |
| K014079 |
12/11/2001 |
DR. HAYS BITE GUARD |
INVENTIVE RESOURCES, INC. |
DAVID W SCHLERF |
| K010304 |
02/01/2001 |
MXR-2000 MOBILE X-RAY UNIT |
IROM IMAGING, INC. |
ROMAN KRYSTYNIAK |
| K010471 |
02/20/2001 |
AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569 |
IRVINE BIOMEDICAL, INC. |
JAMES FARNWORTH |
| K010315 |
02/02/2001 |
ISCREEN VISION SCREENER |
ISCREEN, LLC. |
PETER THRALL |
| K014008 |
12/05/2001 |
HEMOCHRON JR. CITRATE APTT CUVETTE |
ITC, INC. |
JOHN CLAY |
| K010381 |
02/08/2001 |
D.SIGN 30 |
IVOCLAR NORTH AMERICA, INC. |
ANDY GULATI |
| K014082 |
12/11/2001 |
D.SIGN 53, MODEL NA1012204 |
IVOCLAR VIVADENT, INC. |
DONNA M HARTNETT |
| K014042 |
12/07/2001 |
D.SIGN 84 |
IVOCLAR VIVADENT, INC. |
ANDERJEET S GULATI |
| K010328 |
02/02/2001 |
MULTIPLE (IZON DNA BLOOD COLLECTION KIT) |
IZON BUSINESS PRODUCTS, INC. |
JACK WERTZ |
| K014183 |
12/20/2001 |
AFB (ABSORBABLE FOAM BUTTRESS) |
J&J CORPORATE BIOMATERIALS CENTER |
DAVID A DALESSANDRO |
| K014300 |
12/31/2001 |
SAFETOUCH |
JAMES D RUSIN MD, MBA |
JAMES D RUSIN |
| K010546 |
02/23/2001 |
POWDER FREE LATEX EXAMINATION GLOVES |
JB STAR SDN BHD |
Kevin Walls |
| K010416 |
02/12/2001 |
HERACERAM 75 |
JELENKO CO. |
RAPHAEL JUDKINS |
| K010414 |
02/12/2001 |
R & D DESIGNATION AP-035 |
JENSEN INDUSTRIES, INC. |
JOHN SLANSKI |
| K010406 |
02/12/2001 |
JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G |
JMS CO., LTD. |
KEISUKE URATOMI |
| K010410 |
02/12/2001 |
JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G |
JMS CO., LTD. |
KEISUKE URATOMI |
| K014129 |
12/17/2001 |
PROMOGRAN MATRIX WOUND DRESSING |
JOHNSON & JOHNSON MEDICAL, LTD. |
SERGIO J GADALETA |
| K014303 |
12/31/2001 |
JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE |
JOSTRA AG |
KATHLEEN JOHNSON |
| K014204 |
12/21/2001 |
ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822 |
K-JUMP HEALTH CO., LTD. |
JONATHAN S KAHAN |
| K014293 |
12/28/2001 |
K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
| K010569 |
02/26/2001 |
KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP |
KARL STORZ ENDOSCOPY |
JAMES A LEE |
| K014277 |
12/27/2001 |
KSEA DEPLOYABLE CARDIOVASCULAR CLAMP |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
JAMES A LEE |
| K010345 |
02/05/2001 |
KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
JAMES A LEE |
| K010346 |
02/05/2001 |
KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
JAMES A LEE |
| K010340 |
02/05/2001 |
MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI |
KARL STORZ LITHOTRIPSY-AMERICA, INC. |
MARIKA ANDERSON |
| K010543 |
02/23/2001 |
KM-30 TENS ELECTRODE |
KATECHO, INC. |
WARREN R WALTERS |
| K014179 |
12/20/2001 |
DEMETRON LC |
KERR CORP. |
COLLEEN BOSWELL |
| K014027 |
12/06/2001 |
OPTIBOND SOLO PLUS 4 |
KERR DENTAL MATERIALS CENTER |
COLLEEN BOSWELL |
| K013982 |
12/03/2001 |
KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT |
KINAMED, INC. |
VINEET SARIN |
| K013994 |
12/04/2001 |
MODIFICATION TO VIEWSEND MEDICAL |
KLT TELECOM, INC. |
KEN LOGSDON, JR. |
| K010413 |
02/12/2001 |
MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI |
KONICA MINOLTA SENSING, INC. |
NANCI DEXTER |
| K010452 |
02/15/2001 |
BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T |
KOVEN TECHNOLOGY, INC. |
J. HARVEY KNAUSS |
| K010500 |
02/21/2001 |
AUTOMATED WORKCELL CONTROL SOFTWARE |
LAB-INTERLINK, INC. |
DEBORAH S KIPP |
| K014087 |
12/11/2001 |
LATEXX MANUFACTURING NON-CHLORINATED, POLYMER COATED, POWDER-FREE RUBBER LATEX EXAMINATION GLOVE |
LATEXX MANUFACTURING SDN.BHD. |
YOLANDA SMITH |
| K010431 |
02/13/2001 |
LEAD-LOK REUSABLE TENS/ NMES ELECTRODES |
LEAD-LOK, INC. |
CHRIS HEALY |
| K010464 |
02/16/2001 |
RADCALC, MODEL V.4.0 |
LIFELINE SOFTWARE, INC. |
CRAIG A LAUGHTON |
| K010460 |
02/16/2001 |
LIFELINES TRACKIT |
LIFELINES LTD. |
CRHISTINA SMITH |
| K010372 |
02/07/2001 |
LIGHTLAS 532 PHOTOCOAGULATOR |
LIGHTMED CORP. |
GARY LEE |
| K014162 |
12/19/2001 |
MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND |
LOBOB LABORATORIES, INC. |
DANIEL J MANELLI |
| K013999 |
12/04/2001 |
LODOX, MODEL BASELINE |
LODOX SYSTEMS (PTY) LTD. |
BRADLEY SACKS |
| K010600 |
02/28/2001 |
SUPREMA POWERED WHEELCHAIR |
LUIGI CHINETTI |
LUIGI CHINETTI |
| K014117 |
12/14/2001 |
MODIFICATION TO OUTBACK CATHETER |
LUMEND, INC. |
PHIL HOPPER |
| K013985 |
12/03/2001 |
MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX |
MACHNET BV |
DANIEL KAMM |
| K010513 |
02/21/2001 |
CARDIAC VIEW, MODEL 2001 |
MAGNA-LAB, INC. |
LYNN CARTER |
| K010419 |
02/12/2001 |
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES |
MASIMO CORP. |
JAMES J CRONIN |
| K010353 |
02/06/2001 |
MED-LOGICS DISPOSABLE ALK TUBING |
MED-LOGICS, INC. |
GARY MOCNIK |
| K010306 |
02/01/2001 |
MEDCOMP EXCELL SPLIT TIP CATHETER |
MEDCOMP |
JEANNE M CUSH |
| K010549 |
02/26/2001 |
BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS) |
MEDI-GLOBE CORP. |
SCOTT KARLER |
| K013995 |
12/04/2001 |
MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL |
MEDICAL ANALYSIS SYSTEMS, INC. |
PENNY M LAYMAN |
| K014294 |
12/28/2001 |
MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414 |
MEDICAL DATA ELECTRONICS |
GREGORY ALKIRE |
| K010495 |
02/20/2001 |
CENTURA PHOTOTHERAPY SPOTLIGHT |
MEDICAL ILLUMINATION INTERNATIONAL, INC. |
DAVID GLOVER |
| K010338 |
02/05/2001 |
ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200 |
MEDIVANCE, INC. |
LYNNE ARONSON |
| K010561 |
02/26/2001 |
VERDICT -II BAR/BZO |
MEDTOX DIAGNOSTICS, INC. |
MICHAEL TURANCHIK |
| K010564 |
02/26/2001 |
VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO; PROFILE -II 7 THC/COC/OPI/AMP/PCP/BAR/BZO |
MEDTOX DIAGNOSTICS, INC. |
MICHAEL TURANCHIK |
| K014036 |
12/07/2001 |
MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030. |
MEDTRADE PRODUCTS LTD. |
JONATHAN D RANFIELD |
| K014205 |
12/21/2001 |
MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE) |
MEDTRONIC AVE, INC. |
KEVIN DRISCO |
| K014269 |
12/27/2001 |
POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102 |
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
TOVE KJAER |
| K014223 |
12/26/2001 |
MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM |
MEDTRONIC PERCUSURGE, INC. |
MATT MOON |
| K010487 |
02/20/2001 |
BIPOLAR PENCIL, MODEL 3901-002, 3900-002 |
MEDTRONIC PS MEDICAL |
JANET MCAULEY |
| K010361 |
02/06/2001 |
MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900 |
MEDTRONIC PS MEDICAL |
CAROL BACCASH |
| K010341 |
02/05/2001 |
MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,, |
MEDTRONIC PS MEDICAL |
JANET MCAULEY |
| K014296 |
12/31/2001 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD W TREHARNE |
| K010528 |
02/23/2001 |
TITANIUM CEMENT RESTRICTOR MATERIAL PEEK |
MEDTRONIC SOFAMOR DANEK USA, INC. |
RICHARD W TREHARNE |
| K010529 |
02/23/2001 |
TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA |
MEDTRONIC SOFAMOR DANEK USA, INC. |
RICHARD W TREHARNE |
| K014267 |
12/27/2001 |
BUTTERFLY PLATE FIXATION SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
| K013962 |
12/03/2001 |
EQUATION FIXATION SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
| K014076 |
12/11/2001 |
MODIFICATION TO TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
| K010300 |
02/01/2001 |
MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION |
MEDTRONIC VASCULAR |
PAM SCHAUB |
| K013963 |
12/03/2001 |
MODEL 9210 DELIVERY CATHETER, MODEL 9210 |
MEDTRONIC VASCULAR |
MARY E BEST |
| K010579 |
02/27/2001 |
STENT SUPPORT GUIDE CATHETER |
MEDTRONIC VASCULAR |
FRED L BOUCHER |
| K014165 |
12/19/2001 |
STIMULUS - DISSECTION INSTRUMENTS |
MEDTRONIC XOMED, INC. |
MARTIN D SARGENT |
| K010586 |
02/27/2001 |
PALAMED BONE CEMENT |
MERCK BIOMATERIAL GMBH |
THOMAS KIEWITT |
| K014225 |
12/26/2001 |
BREATHTEK - UBIT UBT FOR H. PYLORI |
MERETEK DIAGNOSTICS, INC. |
DENISE E SPELLMAN |
| K014301 |
12/31/2001 |
MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS |
MERITS HEALTH PRODUCTS CO., LTD. |
Lee Leichter |
| K010380 |
02/08/2001 |
MP3HD BIG BOY, POWER WHEELCHAIR |
MERITS HEALTH PRODUCTS., INC. |
WINSTON ANDERSON |
| K010497 |
02/21/2001 |
SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300 |
MICRO THERAPEUTICS, INC. |
EBEN GORDON |
| K014060 |
12/10/2001 |
MICROAIRE 1000E SYSTEM |
MICROAIRE SURGICAL INSTRUMENTS, INC. |
CARL ANGLES |
| K010496 |
02/21/2001 |
CEDIA DAU AMPHETAMINES/ECSTASY ASSAY |
MICROGENICS CORP. |
SHERRIE RINNE |
| K010305 |
02/01/2001 |
WEISS RETINAL CANNULA |
MICRON SURGICAL, INC. |
APRIL DEAN |
| K014272 |
12/27/2001 |
PERIOLASE ND:YAG DENTAL LASER SYSTEM |
MILLENNIUM DENTAL TECHNOLOGIES, INC. |
DAVID M HARRIS |
| K013988 |
12/04/2001 |
MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R |
MILLIPORE CORP. |
THOMAS BORROWS |
| K010377 |
02/08/2001 |
MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385 |
MINIMED, INC. |
JENNIFER LYONS |
| K014016 |
12/05/2001 |
ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER |
MINNTECH CORP. |
LYNN LUCDERS |
| K010366 |
02/07/2001 |
DISPOSABLE STORAGE CAP |
MOLDED PRODUCTS INC. |
ELISE JOHNSTON |
| K010570 |
02/26/2001 |
BREAST IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY 160 |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K014282 |
12/27/2001 |
BACSTOP FILTER,BACSTOP FILTER/HME |
MUNKTELL FILTER AB |
PAUL DRYDEN |
| K014281 |
12/27/2001 |
GARD FILTER, COMBIGARD FILTE / HME |
MUNKTELL FILTER AB |
PAUL DRYDEN |
| K010309 |
02/01/2001 |
SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR |
MUTOH AMERICA CO., LTD. |
DANIEL] KAMM |
| K010589 |
02/27/2001 |
MICROWAVAE DELIVERY SYSTEM #MW2000 |
MW MEDICAL, INC. |
GREG HOLLAND |
| K014121 |
12/17/2001 |
WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860 |
NELLCOR PURITAN BENNETT, INC. |
ANTHONY MULLIN |
| K010424 |
02/13/2001 |
NEXAN SYSTEM, MODEL NX-301 |
NEXAN LTD |
DAVID L WEST |
| K013992 |
12/04/2001 |
NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY |
NICHOLS INSTITUTE DIAGNOSTICS |
ROBERT SCHMIDT |
| K010521 |
02/22/2001 |
NICOLET VERSALAB |
NICOLET BIOMEDICAL |
DAVID W WAGNER |
| K014274 |
12/27/2001 |
NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000 |
NIDEK, INC. |
CAROL PATTERSON |
| K010590 |
02/27/2001 |
NEUROPACK MICRO, MODEL MED-9100A SERIES |
NIHON KOHDEN AMERICA, INC. |
BONNIE BISHOP |
| K014114 |
12/14/2001 |
GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX |
NIPRO DIABETES SYSTEMS, INC. |
KAELYN B HADLEY |
| K014044 |
12/07/2001 |
MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT) |
NOTAL VISION, INC. |
RICHARD E LIPPMAN |
| K014295 |
12/28/2001 |
STAT PROFILE PHOX ANALYZER |
NOVA BIOMEDICAL CORP. |
PAUL W MAC DONALD |
| K010451 |
02/15/2001 |
NOVAMETRIX MARQUETTE COMPATIBLE SENSORS |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
ROBERT H SCHIFFMAN, R.A.C. |
| K010359 |
02/06/2001 |
INNOVO |
NOVO NORDISK A/S |
ROBERT FISCHER |
| K014251 |
12/26/2001 |
NTERO HOTROD SYSTEM |
NTERO SURGICAL, INC. |
BOMMI BOMMANNAN |
| K010417 |
02/12/2001 |
CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304 |
NUCLEAR ASSOC., DIV. INOVISION LP |
CHRISTINE G CASTLEBERRY |
| K014124 |
12/17/2001 |
NUMED COEFFICIENT PTV CATHETERS |
NUMED, INC. |
NICHELLE R LAFLASH |
| K014152 |
12/18/2001 |
NXSTAGE CARTRIDGE EXPRESS |
NXSTAGE MEDICAL, INC. |
NORMA LEMAY |
| K014170 |
12/20/2001 |
STAURENGHI WIDE FIELD SCANNING LASER LENS |
OCULAR INSTRUMENTS, INC. |
RAYMOND GRAHAM |
| K010388 |
02/08/2001 |
SONDREX P.A.L. SYSTEM |
OHMEDA MEDICAL |
ALBERTO F PROFUMO |
| K014015 |
12/05/2001 |
OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRATOR; OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA |
OLYMPUS AMERICA, INC. |
MICHAEL CAMPBELL |
| K014032 |
12/06/2001 |
OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA |
OLYMPUS AMERICA, INC. |
MICHAEL CAMPBELL |
| K010591 |
02/28/2001 |
OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER |
OLYMPUS OPTICAL CO., LTD. |
TSUYOSHI YANAI |
| K014166 |
12/19/2001 |
UHI-3 HIGH FLOW INSUFFLATION UNIT |
OLYMPUS OPTICAL CO., LTD. |
LAURA STORMS-TYLER |
| K014078 |
12/11/2001 |
ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM |
ON SITE GAS SYSTEMS, INC. |
C. BARTON GULLONG |
| K014286 |
12/27/2001 |
SALUTE, MODEL 3022 |
ONUX MEDICAL, INC. |
RUTHANN DEPIETRO |
| K014100 |
12/13/2001 |
OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND |
OPUSDENT LTD. |
ARAVA HACOHEN |
| K014001 |
12/04/2001 |
DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3 |
ORAL OSTEODISTRACTION, L.P. |
ARTHUR WARD |
| K010322 |
02/02/2001 |
ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR) |
ORTHODYNE, INC. |
CARL KNOBLOCH |
| K014189 |
12/21/2001 |
ODI TALON INTRAMEDULLARY HIP NAIL |
ORTHOPEDIC DESIGNS, INC. |
JOHN SODEIKA |
| K010369 |
02/07/2001 |
CLARIS PLATE SYSTEM |
ORTHOTEC, L.L.C. |
PATRICK BERTRANOU |
| K010537 |
02/23/2001 |
LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
AMANDA SHEPPARD |
| K010536 |
02/23/2001 |
MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
AMANDA SHEPPARD |
| K014209 |
12/21/2001 |
PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS |
PADPRO LLC. |
DANIEL KAMM |
| K010580 |
02/27/2001 |
PALOMAR SLP 1000 |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
Marcy Moore |
| K014253 |
12/26/2001 |
DERMACHILLER 4 |
PARADIGM TREX, LLC |
NIKOLAI TANKOVICH |
| K010475 |
02/20/2001 |
D/C CORE MATERIAL |
PARKELL, INC. |
NELSON J GENDUSA |
| K010508 |
02/21/2001 |
PASCO MIC AND MIC/ID PANELS |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
| K011116 |
02/21/2001 |
PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST |
PASCO LABORATORIES, INC. |
LINDA DILLON |
| K010467 |
02/16/2001 |
UNIVERSAL DENTAL COPING (UDC) |
PAXMED INTERNATIONAL |
FLOYD G LARSON |
| K010317 |
02/02/2001 |
AV 800 VENTILATOR |
PENLON LTD. |
ANTHONY PARSONS |
| K010318 |
02/02/2001 |
PRIMA OXYGEN MONITOR |
PENLON LTD. |
ANTHONY PARSONS |
| K014268 |
12/27/2001 |
NORAPAD PLAIN; NORAPAD TA |
PERLEI MEDICAL, INC. |
ART WARD |
| K010365 |
02/07/2001 |
ORTHO CONTROL FEMALE URINARY CONTROL DEVICE |
PERSONAL PRODUCTS CO. |
MARYLOU PANICO |
| K014157 |
12/19/2001 |
HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A |
PHILIPS MEDICAL SYSTEMS |
TAMARA YOUNT |
| K014191 |
12/21/2001 |
M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540 |
PHILIPS MEDICAL SYSTEMS |
STEVE SINGLAR |
| K014181 |
12/20/2001 |
M2376A DEVICELINK SYSTEM, MODEL M2376A |
PHILIPS MEDICAL SYSTEMS, INC. |
MIKE HUDON |
| K010435 |
02/13/2001 |
PHILIPS BV PULSERA/ENDURA |
PHILIPS MEDICAL SYSTEMS, INC. |
MARCIA JONES |
| K014159 |
12/19/2001 |
PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM; PHILLIPS V24/V26 PATIENT MONITOR |
PHILIPS MEDICAL SYSTEMS, INC. |
DAVE OSBORN |
| K014261 |
12/27/2001 |
ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.0 |
PHILIPS MEDICAL SYSTEMS, INC. |
DAVE OSBORN |
| K014302 |
12/31/2001 |
UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM |
PISHARODI SURGICALS, INC. |
MADHAVEN PISHARODI |
| K014167 |
12/19/2001 |
LIBERTY BLOOD GLUCOSE MONITORING SYSTEM |
POLYMEDICA PHARMACEUTICALS, U.S.A., INC.] |
PATRICIA COLLINS |
| K010456 |
02/16/2001 |
BIOSCANNER CREATININE TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
| K014099 |
12/13/2001 |
BIOSCANNER PLUS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
| K014115 |
12/14/2001 |
1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX |
PORTEX, INC. |
TIMOTHY J TALCOTT |
| K014073 |
12/10/2001 |
HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE |
PORTEX, INC. |
BRAIN E FARIAS |
| K013970 |
12/03/2001 |
PRIME-DENT HEMA DESENSITIZER |
PRIME DENTAL MANUFACTURING, INC. |
ROLANDO MARASIGAN |
| K014084 |
12/11/2001 |
NYCOCARD CRP CONTROL |
PRIMUS CORP. |
JIM NOFFSINGER |
| K014069 |
12/10/2001 |
LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K014067 |
12/10/2001 |
LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K014193 |
12/21/2001 |
LIFESIGN DOA 4 (THC/OPI/COC/MET) |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K014192 |
12/21/2001 |
LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K014066 |
12/10/2001 |
LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K010454 |
02/15/2001 |
THE ALBERTA LENS SM2, SULFOCON B |
PROGRESSIVE OPTICAL RESEARCH LTD. |
NICK NOVICKY |
| K010400 |
02/12/2001 |
VACUUM ASSISTED CORE BIOPSY DEVICE |
PROMEX, INC. |
JOSEPH L MARK |
| K013996 |
12/03/2001 |
LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE |
PT. MAJA AGUNG LATEXINDO |
EMMY T JOENG |
| K010486 |
02/20/2001 |
POLYMER COATED POWDER-FREE GREY COLOR POLYCHLOROPRENE PATIENT EXAMINATION GLOVES |
PT. MEDISAFE TECHNOLOGIES |
ANIL TANEJA |
| K010483 |
02/20/2001 |
POWDERFREE COLORED LATEX EXAMINATION GLOVES (PINK, BLUE, GREEN, AND WHITE) WITH PROTEIN CONTENT LABELING CLAIM (50 MICR0 |
PT. MEDISAFE TECHNOLOGIES |
ANIL TANEJA |
| K014133 |
12/17/2001 |
PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE |
PULPDENT CORP. |
KENNETH J BERK |
| K014059 |
12/10/2001 |
PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE |
PULPDENT CORP. |
KENNETH J BERK |
| K014138 |
12/17/2001 |
PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT |
PULPDENT CORP. |
KENNETH J BERK |
| K010337 |
02/05/2001 |
LIPOPRINT SYSTEM, LDL SUBFRACTIONS |
QUANTIMETRIX CORP. |
GEBHARD NEYER |
| K010598 |
02/28/2001 |
SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL |
QUANTIMETRIX CORP. |
EVA LASZLO |
| K010461 |
02/16/2001 |
ADVIA RETIC PLUS |
R & D SYSTEMS, INC. |
KENNETH T EDDS |
| K010409 |
02/12/2001 |
CBC-SF |
R & D SYSTEMS, INC. |
KENNETH T EDDS |
| K010470 |
02/20/2001 |
R & D 4K RETIC |
R & D SYSTEMS, INC. |
KENNETH T EDDS |
| K010548 |
02/26/2001 |
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) |
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP |
KEVIN J O'CONNELL |
| K010538 |
02/23/2001 |
PARSET NEEDLELESS PRIMARY SET FOR BLUNT CANNULA, A10003E, PARSET NEEDLELESS SECONDARY SET WITH BLUNT CANNULA, A14003E |
RD MEDICAL MFG., INC. |
CARLOS A RODRIGUEZ-GARCIA |
| K010436 |
02/13/2001 |
TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011 |
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
CHRIS HANNAN |
| K014126 |
12/17/2001 |
SANIDAD HEALTH-UP TENS MP-73725 |
ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY |
JEN KE-MIN |
| K010362 |
02/06/2001 |
ACCU-CHEK COMFORT CURVE TEST STRIP |
ROCHE DIAGNOSTICS CORP. |
MIKE FLIS |
| K014139 |
12/17/2001 |
DIABETES ASSISTANT SOFTWARE |
ROCHE DIAGNOSTICS CORP. |
Scott Thiel |
| K010588 |
02/27/2001 |
ELECSYSCA 15-3 II ASSAY |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K010498 |
02/21/2001 |
WRISTWATCH BLOOD PRESSURE MONITOR A46 |
ROSSMAX INTERNATIONL LTD. |
MICHAEL YEH |
| K010596 |
02/28/2001 |
RUSCH BRONCHUS BLOCKER KIT |
RUSCH INTL. |
KARENANN J BROZOWSKI |
| K010420 |
02/12/2001 |
RUSCH MMG/O'NEIL CATHETER |
RUSCH, INC. |
WILLIAM SLEVIN |
| K014208 |
12/21/2001 |
SSIR SYSTEM |
RUSSIAN-AMERICAN TECHNOLOGY ASSOCIATES, INC. |
JOYCE HEINRICH |
| K014273 |
12/27/2001 |
ACUSTIM |
S.H.P. INTL. PTY., LTD. |
E.D. RICHARDS |
| K010593 |
02/28/2001 |
SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT |
SA SCIENTIFIC, INC. |
ARBI A SHADFAN |
| K010522 |
02/22/2001 |
SUREVUE URINE HCG |
SA SCIENTIFIC, INC. |
HARBI A SHADFAN |
| K010502 |
02/21/2001 |
MODEL THERMO TEK QUICKCARE |
SAAT LTD. |
E. J SMITH |
| K013980 |
12/03/2001 |
SAFE SHIELD PRE-POWDERED LATEX EXAMINATION GLOVES |
SAFE SHIELD CO. LTD |
SUSAN D GOLDSTEIN-FALK |
| K014056 |
12/10/2001 |
SALTER LABS MODIFIED NEBUTECH NEBULIZER |
SALTER LABS |
DUANE KAZAL |
| K010559 |
02/26/2001 |
SAUFLON MULTI LENS CARE SYSTEM |
SAUFLON PHARMACEUTICALS, LTD. |
LIGIA DELACRUZ |
| K010519 |
02/22/2001 |
MAGNUM FLOW IRRIGATION SYSTEM |
SCION VALLEY, INC. |
C. KENNETH FRENCH |
| K014055 |
12/10/2001 |
NON-STERILE POWDERED LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM ON LABELING |
SEAL POLYMER INDUSTRIES BHD. |
CHUN C FONG |
| K010382 |
02/08/2001 |
100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I |
SENSIDYNE, INC. |
GEORGE MASON |
| K014038 |
12/07/2001 |
PYLORITEK VP TEST KIT 5140VP |
SERIM RESEARCH CORP. |
PATRICIA RUPUCHOCK |
| K013998 |
12/04/2001 |
POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES |
SHEEN MORE ENT. CO., LTD. |
JANNA P TUCKER |
| K014077 |
12/11/2001 |
POWDER FREE (BLUE) NITRILE PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT |
JAMES CHU |
| K014112 |
12/14/2001 |
SATARI LATEX PATIENT EXAMINATION POWDERED GLOVE SINGLE SIDE POLYMER COATED, NON STERILE, 200 MG OR LESS OF TOTAL WATER E |
SIAM SEMPERMED CORP. LTD. |
JAY MANSOUR |
| K014110 |
12/14/2001 |
SATARI POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) POLYMER COATED WHIT |
SIAM SEMPERMED CORP. LTD. |
JAY MANSOUR |
| K014113 |
12/14/2001 |
ENDOMAP |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SANDRA ROBINSON |
| K014213 |
12/21/2001 |
SIEMENS INFINITY GATEWAY SUITE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K010426 |
02/13/2001 |
PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER |
SIMS DELTEC, INC. |
LISA J STONE |
| K010489 |
02/20/2001 |
DYONICS VISION 111 MOBILE VIDEO UNIT |
SMITH & NEPHEW, INC. |
STEVEN JACKSON |
| K010555 |
02/26/2001 |
JAX |
SMITH & NEPHEW, INC. |
KIM P KELLY |
| K010557 |
02/26/2001 |
JAX GRANULES BONE VOID FILLER |
SMITH & NEPHEW, INC. |
TRUDE C MCLEAN |
| K013989 |
12/04/2001 |
ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER |
SMITH & NEPHEW, INC. |
JANET JOHNSON GREEN |
| K010509 |
02/21/2001 |
CEDARS-SINAI BPGS AND MOCO |
SMV AMERICA |
PAULA MCLEAN |
| K014116 |
12/14/2001 |
HAND-CARRIED ULTRASOUND SYSTEM |
SONOSITE,INC. |
MICHAEL HOFFMAN |
| K010374 |
02/07/2001 |
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM |
SONOSITE,INC. |
MICHAEL A HOFFMAN |
| K014299 |
12/31/2001 |
SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH |
SORBA MEDICAL SYSTEMS, INC. |
JILL BARNEY |
| K014211 |
12/21/2001 |
OXYARM CO2 |
SOUTHMEDIC, INC. |
PAUL E DRYDEN |
| K010415 |
02/12/2001 |
ISODAN |
SPECIALITES SEPTODONT |
PETER S REICHERZ |
| K014105 |
12/13/2001 |
SPECTRAL'S TROPONIN I |
SPECTRAL DIAGNOSTICS, INC. |
NISAR A SHAIKH |
| K010563 |
02/26/2001 |
END-TO-END AND SIDE-BY-SIDE CONNECTORS |
SPINAL CONCEPTS, INC. |
DAVID M HOOPER |
| K013979 |
12/03/2001 |
SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEM |
SPINAL CONCEPTS, INC. |
DAVID M HOOPER |
| K014200 |
12/21/2001 |
OPTIMESH |
SPINEOLOGY, INC. |
PAMELA R SNYDER |
| K014037 |
12/07/2001 |
SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE) |
ST. JUDE MEDICAL, INC. |
WILLIAM MCKELVEY |
| K014161 |
12/19/2001 |
SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE) |
ST. JUDE MEDICAL, INC. |
WILLIAM MCKELVEY |
| K014049 |
12/10/2001 |
EPOCA CODR STEM AND HEAD |
STELKAST COMPANY |
DONALD A STEVENS |
| K013993 |
12/04/2001 |
NEOCALEX |
STEPHEN M KORAL, DMD |
STEPHEN M KORAL |
| K010534 |
02/23/2001 |
CROSS-CHECKS DUAL, MODEL CI 125 |
STERITEC PRODUCTS, INC. |
LINDA NELSON |
| K014062 |
12/10/2001 |
SIMPLICITY EASY ACCESS INFUSION SET |
STERLING MEDIVATIONS, INC. |
JOEL S DOUGLAS |
| K010373 |
02/07/2001 |
SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFUSION PUMPS AND MINIMED MEDICATION RESERVOIRS (MODEL MMT-103) |
STERLING MEDIVATIONS, INC. |
JOEL DOUGLASS |
| K014061 |
12/10/2001 |
SIMPLICITY STARPLUS SOFT INFUSION SET |
STERLING MEDIVATIONS, INC. |
JOEL S DOUGLAS |
| K014091 |
12/12/2001 |
STRYKER PAINPUMP |
STRYKER CORP. |
NICOLE PETTY |
| K014263 |
12/27/2001 |
NEWGEN/UNIVERSAL MANDIBULAR SYSTEM |
STRYKER INSTRUMENTS |
ROBIN L ROWE |
| K014050 |
12/10/2001 |
HEX-LOCK TEMPORARY ABUTMENT |
SULZER DENTAL, INC. |
SEAN HARIRI |
| K014175 |
12/20/2001 |
SULZER DENTAL CERAMIC SYSTEM-HEXLOCK |
SULZER DENTAL, INC. |
SEAN HARIRI |
| K014214 |
12/21/2001 |
SULZER DENTAL CERAMIC SYSTEM-SPLINE |
SULZER DENTAL, INC. |
SEAN HARIRI |
| K014136 |
12/17/2001 |
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY |
SULZER INTRATHERAPEUTICS, INC. |
MARIA E BRITTLE |
| K014089 |
12/11/2001 |
VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES |
SUN BIOMEDICAL LABORATORIES, INC. |
MING SUN |
| K010449 |
02/15/2001 |
IVD (IN VIVO DOSIMETER), MODEL 1131 |
SUN NUCLEAR CORP. |
NOEL M DOWNEY |
| K014140 |
12/17/2001 |
RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET |
SUNDER BIOMEDICAL TECH. CO., LTD. |
TONY HUNG |
| K014134 |
12/17/2001 |
POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G) |
SUPERGRADE HEALTHCARE PRODUCTS SDN. BHD. |
JANNA P TUCKER |
| K014230 |
12/26/2001 |
STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) |
SUPERMAX GLOVE MANUFACTURING SDN BHD |
STANLEY THAI |
| K010371 |
02/07/2001 |
LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT |
SURETEX, LTD. |
LON D MCILVAIN |
| K010542 |
02/23/2001 |
SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION |
SURGICAL NAVIGATION SPECIALISTS, INC. |
CAROL NAKAGAWA |
| K014021 |
12/06/2001 |
SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYED |
SURGICAL SPECIALTIES CORP. |
ELIZABETH LAZARO |
| K014033 |
12/07/2001 |
EMORY CARDIAC TOOLBOX 2.1 EXECUTING ON NUCLEAR MEDICINE COMPUTERS |
SYNTERMED, INC. |
KENNETH F VAN TRAIN |
| K010344 |
02/05/2001 |
ADJUSTABLE LARGE FIXATOR SYSTEM |
SYNTHES (USA) |
BONNIE J SMITH |
| K010321 |
02/02/2001 |
MODULAR FOOT SYSTEM - 2.7 MM MODULE |
SYNTHES (USA) |
THOMAS M MAGUIRE |
| K010527 |
02/22/2001 |
SYNTHES (USA) IMF SCREWS |
SYNTHES (USA) |
THOMAS M MAGUIRE |
| K010499 |
02/21/2001 |
SYNTHES (USA) MIDFACE DISTRACTOR |
SYNTHES (USA) |
THOMAS M MAGUIRE |
| K010518 |
02/22/2001 |
SYNTHES ANTEROLATERAL CALCANEAL PLATE |
SYNTHES (USA) |
THOMAS M MAGUIRE |
| K014197 |
12/21/2001 |
SYNTHES HIGH TIBIAL OSTEOTOMY PLATE |
SYNTHES (USA) |
MATTHEW M HULL |
| K010578 |
02/27/2001 |
TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017 |
TAGA MEDICAL TECHNOLOGIES, INC. |
GARY AUSTIN |
| K014198 |
12/21/2001 |
BIOTECH B990K VIVI WHEELCHAIR |
TAIWAN ARMADA ENTERPRISE CO., LTD. |
Ke-Min Jen |
| K014009 |
12/05/2001 |
TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TANITA ULTIMATE SCALE |
TANITA CORP. OF AMERICA |
CAROL ALLOIAN (BENSON) |
| K010412 |
02/12/2001 |
FLEXIBLE ENDOSCOPIC SCISSORS |
TELEMED SYSTEMS, INC. |
MICHAEL CARROLL |
| K010383 |
02/08/2001 |
TEMP SCAN |
TENGHI CO. LTD |
TONY C S. CHANG |
| K010438 |
02/13/2001 |
MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50 MICRGRAMS OR LESS) |
TERANG NUSA SDN BHD |
CHIN-GUAN LOW |
| K010439 |
02/12/2001 |
MAXITEX DUPLEX STERILE LATEX POWDERED SURGEON GLOVES WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS) |
TERANG NUSA SDN BHD |
CHIN-GUAN LOW |
| K010443 |
02/14/2001 |
CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
GARRY A COURTNEY |
| K014182 |
12/20/2001 |
TETRAD MODEL TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TRANSDUCERS |
TETRAD CORP. |
CHARLES F HOTTINGER |
| K010441 |
02/13/2001 |
FREELITE KAPPA FREE KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K010440 |
02/13/2001 |
FREELITE LAMBDA FREE KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K014270 |
12/27/2001 |
MININEPH HUMAN B2-MICROGLOBULIN KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K010401 |
02/12/2001 |
TRI-PLEX ADAPTER |
THE MEDICAL DEVICE GROUP, INC. |
E.J. Smith |
| K010466 |
02/16/2001 |
TETHER ACFS |
THEKEN SURGICAL,LLC |
ROBERT THEKEN |
| K010472 |
02/20/2001 |
PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50 |
THOMSON & NIELSEN ELECTRONICS, LTD. |
ANDREW HARTSHORN |
| K014260 |
12/27/2001 |
TISSUELINK SOLID CYLINDER MONOPOLAR DEVICE |
TISSUELINK MEDICAL, INC. |
VICKI ANASTASI |
| K014258 |
12/26/2001 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K014259 |
12/26/2001 |
SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K010545 |
02/23/2001 |
TBW |
TRI-MED, INC. |
ROBERT J MEDOFF |
| K014243 |
12/26/2001 |
BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL BMCD-35-3040, MBCD-35-4050 |
TRIAGE MEDICAL INC |
BRAD CULBERT |
| K014304 |
12/31/2001 |
BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S |
TRIAGE MEDICAL INC |
BRAD CULBERT |
| K013974 |
12/03/2001 |
RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A |
TRIMEDYNE, INC. |
SUSAN H GAMBLE |
| K014233 |
12/26/2001 |
CAPTIAM SYPHILIS-G ASSAY |
TRINITY BIOTECH, PLC |
FIONA CAMPBELL |
| K014248 |
12/26/2001 |
DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER |
UROGYN LTD. |
EREZ ADIV |
| K014086 |
12/11/2001 |
CTL BODY / SPINE ARRAY COIL |
USA INSTRUMENTS, INC. |
RONY THOMAS |
| K014011 |
12/05/2001 |
CANVAS N-VAS-D 2.0 |
VASSOL, INC. |
LYNETTE L HOWARD |
| K014127 |
12/17/2001 |
KARMA DISCOVERY, MODEL KP40 |
VESTIL MANUFACTURING CORP. |
RICH MICHAEL |
| K014224 |
12/26/2001 |
PRECISION PLUS TUNA OFFICE SYSTEM |
VIDAMED, INC. |
YI CHEN |
| K014154 |
12/18/2001 |
VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00 |
VILEX, INC. |
ABRAHIM LAVI |
| K013973 |
12/03/2001 |
ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CLEAR AND TINTED (VISIBILITY AND/OR COSMETIC) WITH UV BLOC |
VISTAKON |
JAMES W PARZIALE |
| K010507 |
02/21/2001 |
VISTAKON (METHAFILCON A) CONTACT LENSES |
VISTAKON |
MICHAEL J TERSAK |
| K014111 |
12/14/2001 |
REBILDA SC |
VOCO GMBH |
EVAN DICK |
| K014068 |
12/10/2001 |
ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115 |
W & H DENTALWERK BUERMOOS GMBH |
RALF BENDA |
| K014215 |
12/21/2001 |
VIABIL BILIARY ENDOPROSTHESIS |
W.L. GORE & ASSOCIATES,INC |
JACQUELINE KALBACH |
| K010326 |
02/02/2001 |
WAKO AUTOKIT C3 |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K010325 |
02/02/2001 |
WAKO AUTOKIT C4 |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K010332 |
02/02/2001 |
WAKO IMMUNOASSAY CALIBRATOR SET |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K010334 |
02/02/2001 |
WAKO LIPID CALIBRATOR |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K010427 |
02/13/2001 |
LORENZ FIDUCAIL SCREW |
WALTER LORENZ SURGICAL, INC. |
KIM REED |
| K014148 |
12/18/2001 |
SELF-DRILLING RADIOGRAPHIC MARKER |
WALTER LORENZ SURGICAL, INC. |
KIM REED |
| K010447 |
02/13/2001 |
MODIFICATION TO ACTICOAT FOAM DRESSING |
WESTAIM BIOMEDICAL, INC. |
Steve Chartier |
| K013983 |
12/03/2001 |
WIENER LAB. ALP 405 |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
| K010421 |
02/12/2001 |
WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105 |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
| K014158 |
12/19/2001 |
ENDOSCOPIC CAMERA TC804/C4 |
WORLD OF MEDICINE LEMKE GMBH |
SUSANNE RAAB |
| K014171 |
12/20/2001 |
ADVANCE UNICONDYLAR KNEE SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
EHAB M ESMAIL |
| K010532 |
02/23/2001 |
OSTEOSET BVF KIT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
EHAB M ESMAIL |
| K014288 |
12/28/2001 |
DERMGRIP POWDER FREE POLYMER COATED LATEX SURGEON'S GLOVES,STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM ORS |
WRP SPECIALTY PRODUCTS SDN. BHD. |
MOHD H HUSSEIN |
| K014119 |
12/17/2001 |
WU'S 3-WHEELED NEO SCOOTER, WT-M3 |
WU'S TECH CO., LTD. |
Ke-Min Jen |
| K014147 |
12/18/2001 |
80 CHANNEL EEG |
XLTEK |
SONJA MARKEZ |
| K014146 |
12/18/2001 |
84 CHANNEL EEG |
XLTEK |
SONJA MARKEZ |
| K014070 |
12/10/2001 |
EPOCH HIP PROSTHESIS, MODEL 4075 SERIES |
ZIMMER, INC. |
KAREN CAIN |
| K013991 |
12/04/2001 |
PROLONG HIGHLY CROSSLINKED POLYETHTYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS |
ZIMMER, INC. |
STEPHEN H MCKELVEY |
