FDA 510(k) Applications Received During September, 2001

FDA 510(k) Number Submission Date Device Name Applicant Contact
K012998 09/06/2001 AMPHETAMINE/METHAMPHETAMINE ABBOTT LABORATORIES ALICIA SIMPSON
K012996 09/06/2001 BARBITURATES ABBOTT LABORATORIES LINDA MORRIS
K013143 09/20/2001 BENZODIAZEPINES ABBOTT LABORATORIES LINDA MORRIS
K013247 09/28/2001 CANNABINOIDS ABBOTT LABORATORIES LINDA MORRIS
K013004 09/06/2001 COCAINE ABBOTT LABORATORIES ALICIA SIMPSON
K013001 09/06/2001 METHADONE ABBOTT LABORATORIES ALICIA SIMPSON
K013096 09/17/2001 PHENCYCLIDINE ABBOTT LABORATORIES LINDA MORRIS
K013100 09/17/2001 PROPOXYPHENE ABBOTT LABORATORIES LINDA MORRIS
K012975 09/05/2001 SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS ABBOTT LABORATORIES JANET S CONNOLLY
K012983 09/05/2001 ACIST 4 FRENCH ANGIOGRAPHIC CATHETER ACIST MEDICAL SYSTEMS, INC. CARL M BEAURLINE
K013003 09/06/2001 APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER ADVANCED STERILIZATION PRODUCTS NATALIE BENNINGTON
K012986 09/06/2001 BIPOLAR IRRIGATION FORCEPS AESCULAP, INC. LISA M MILLINGTON
K013176 09/24/2001 MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE AFP IMAGING CORP. MARY MCNAMARA-CULLINANE
K013138 09/19/2001 ADC COMPACT PLUS AGFA-GEVAERT AG T. WHIT ATHEY
K013087 09/17/2001 SINGLE DOSE DISPENSING PIN, MODEL 2201 ALARIS MEDICAL SYSTEMS, INC. RENEE L FLUET
K012984 09/06/2001 BREATHABLE IMPERVIOUS GOWNS ALLEGIANCE HEALTHCARE CORP. SHARON ROBBINS
K013180 09/24/2001 RAPIDONE-ECSTASY TEST AMERICAN BIO MEDICA CORP. HENRY WELLS
K013168 09/21/2001 IMUBIND PLASMA PAI-1 ELISA,MODEL 822 AMERICAN DIAGNOSTICA, INC. JOHN B BERRYMAN
K012968 09/04/2001 APPLIED ACCESS SEAL APPLIED MEDICAL RESOURCES CORP. ANIL BHALANI
K013231 09/27/2001 AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035L AVID N.I.T., INC. SCOTT HENDERSON
K013232 09/27/2001 CYBERCASES BY BAUSCH & LOMB BAUSCH & LOMB, INC. KIM S DEVITTO
K012988 09/06/2001 HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469 BAXTER HEALTHCARE CORP. DAVID E CURTIN
K013171 09/24/2001 3420 DIGIT PULSE OXIMETER, MODEL 3420 BCI, INC. DONALD ALEXANDER
K013235 09/28/2001 MODIFICATION TO SYNCHRON CONTROL BECKMAN COULTER, INC. MARY BETH TANG
K013076 09/14/2001 SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR BECKMAN COULTER, INC. MARY BETH TANG
K013073 09/14/2001 INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. LESLIE WOOD
K013062 09/12/2001 BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT BIOCHECK, INC. ROBIN J HELLEN
K012997 09/06/2001 COLLATEK FOAM BIOCORE MEDICAL TECHNOLOGIES, INC. AJAY KUMAR
K012990 09/06/2001 COLLATEK POWDER BIOCORE MEDICAL TECHNOLOGIES, INC. AJAY KUMAR
K012995 09/06/2001 COLLATEK SHEET BIOCORE MEDICAL TECHNOLOGIES, INC. AJAY KUMAR
K013243 09/28/2001 COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1 BIOFORM, INC. VICTOR M BOWERS
K012955 09/04/2001 COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER BIOFORM, INC. VICTOR M BOWERS
K013148 09/20/2001 BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) BIOGENEX LABORATORIES GURVINDER S NANDA
K012960 09/04/2001 BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR BIOGENEX LABORATORIES GURVINDER S NANDA
K013193 09/24/2001 MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE BIOLITEC, INC. CAROL J MORELLO
K013042 09/10/2001 DISCOVERY ELBOW BIOMET ORTHOPEDICS, INC. SARA B SHULTZ
K013147 09/20/2001 GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE BIONOSTICS, INC. KATHY STORRO
K013057 09/12/2001 BIOCUFF,C, MODELS 236018, 236028, 236036 BIONX IMPLANTS, INC. TUIJA ANNALA
K013055 09/11/2001 THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM BIOPLATE, INC. CAROL E JONES
K013050 09/11/2001 THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM BIOPLATE, INC. CAROL E JONES
K013083 09/14/2001 CARTO XP EP NAVIGATION SYSTEM BIOSENSE WEBSTER, INC. AMY WALTERS
K013002 09/06/2001 TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002 BIOSITE INCORPORATED JEFFREY R DAHLEN
K012999 09/06/2001 TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001 BIOSITE INCORPORATED JEFFREY R DAHLEN
K013194 09/25/2001 UNIMARK HCG COMBO PREGNANCY TEST BIOTECH ATLANTIC, INC. FRANCIS LEE
K013151 09/20/2001 ASMOTOM AUTOMATED TREPHINE SYSTEM BKG OPTHALMICS USA, INC. ART WARD
K013177 09/24/2001 MULTITAK SUTURE SNAP SYSTEM BONUTTI RESEARCH, INC. PATRICK BALSMANN
K013153 09/20/2001 AUTOTOME RX MODEL # 4515, 4516 BOSTON SCIENTIFIC CORP. LISA M QUAGLIA
K012985 09/06/2001 MATRIX DETACHABLE COILS BOSTON SCIENTIFIC, TARGET SETH A SCHULMAN
K012952 09/04/2001 HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT BOSTON SCIENTIFIC/MEDI-TECH JENNIFER BOLTON
K012948 09/04/2001 MODIFICATION TO VAXCEL DIALYSIS CATHETER BOSTON SCIENTIFIC/MEDI-TECH NICHOLAS CONDAKES
K013124 09/19/2001 MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP BRANAN MEDICAL CORP. RAPHAEL WONG
K013111 09/18/2001 EXHALE PROBE BRONCUS TECHNOLOGIES, INC. TIMOTHY R WILLIAMS
K013144 09/20/2001 DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE; DUAL PORT WIZARD FEEDING/DECOMPRESSION TUBE, MODEL 00220W C.R. BARD, INC. MARION GORDON
K013251 09/28/2001 SPIRIT 300 CAIRE, INC. ROGER BRIESE
K013032 09/10/2001 PHYSIOLOG, SERIES 95000 CAMTRONICS, LTD. SCOTT J PEASE
K013043 09/10/2001 CANDELA CLEARBEAM PULSED DYE LASER CANDELA CORP. JOAN CLIFFORD
K013234 09/27/2001 MICROJET CRONO CANE SRL DANIEL KAMM
K013019 09/07/2001 "DATACAPTOR" CAPSULE TECHNOLOGIE DANIEL KAMM
K013175 09/24/2001 TM2000 EASYTRACE PLUS RECEIVING CENTER CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K013201 09/25/2001 CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR CARDIOFOCUS, INC. JOHN GREENBAUM
K013204 09/25/2001 AQUIFY LENS COMFORT DROPS CIBA VISION CORPORATION STEVEN DOWDLEY
K013165 09/21/2001 USA SERIES LAPAROSCOPES CIRCON ACMI WAYNE B STERNER
K012951 09/04/2001 APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE CIRCON VIDEO WAYNE B STERNER
K013112 09/18/2001 FOCAL SIM COMPUTERIZED MEDICAL SYSTEMS, INC. MICHAEL A PARSONS
K013216 09/26/2001 DIODENT DENTAL LASER SYSTEM CONTINUUM ELECTRO-OPTICS, INC. RONALD KOHLHARDT
K013241 09/28/2001 ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET COOK, INC. HEIDI MASTEN
K013252 09/28/2001 PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET COOK, INC. HEIDI MASTEN
K013182 09/24/2001 TRIPLE LUMEN CENTRAL VENOUS CATHETER COOK, INC. LISA HOPKINS
K012993 09/06/2001 MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM CORDIS CORP. SAM MIRZA
K013079 09/14/2001 REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT CORGENIX, INC. NANCI DEXTER
K013080 09/14/2001 REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT CORGENIX, INC. NANCI DEXTER
K013077 09/14/2001 REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT CORGENIX, INC. NANCI DEXTER
K013018 09/07/2001 REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT CORGENIX, INC. NANCI DEXTER
K013169 09/21/2001 IMMUNE CELL FUNCTION ASSAY CYLEX, INC. JUDI SMITH
K013114 09/18/2001 BCS SYSTEM DADE BEHRING, INC. REBECCA S AYASH
K013155 09/21/2001 DADE THROMBOPLASTIN C PLUS DADE BEHRING, INC. RADAMES RIESGO
K013128 09/19/2001 N LATEX LP(A) DADE BEHRING, INC. REBECCA S AYASH
K013130 09/19/2001 N LP(A) CONTROL SY DADE BEHRING, INC. REBECCA S AYASH
K013126 09/19/2001 N LP(A) STANDARD SY DADE BEHRING, INC. REBECCA S AYASH
K013210 09/26/2001 TRUWAVE DAN MED, INC. THOMAS SANDGAARD
K013156 09/21/2001 MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM DATA CRITICAL CORP. TERESA DAVIDSON
K013246 09/28/2001 DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01 DATEX-OHMEDA JOEL KENT
K013230 09/27/2001 CERCON BASE DEGUSSA - NEY DENTAL, INC. THOMAS CAMERON
K013049 09/11/2001 NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE DENNIS R. BAILEY, DDS DENNIS R BAILEY
K013154 09/20/2001 MARK II/MARK III MANOMETRIC PERFUSION PUMP DENTSLEEVE PTY., LTD. ROBERT N CLARK
K012971 09/05/2001 ISOLA SPINAL SYSTEMS DEPUY ACROMED LISA GILMAN
K013222 09/27/2001 SUMMIT OCCIPITO-CERVICO- THORACIC (OCT) SPINAL SYSTEM DEPUY ACROMED KAREN F JURCZAK
K013178 09/24/2001 DC-UIBC-CO2-CAL, MODEL SE-153 DIAGNOSTIC CHEMICALS LTD. NANCY OLSCAMP
K013134 09/19/2001 IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS) DIAGNOSTIC PRODUCTS CORP. EDWARDS M LEVINE
K013135 09/19/2001 IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS) DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K012967 09/04/2001 MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING SYSTEM DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. ELAD MAGAL
K013236 09/28/2001 LUXABITE DMG USA, INC. PAMELA PAPINEAU
K013179 09/24/2001 LUXAGLAZE DMG USA, INC. PAMELA PAPINEAU
K013237 09/28/2001 STATUSBLUE DMG USA, INC. PAMELA PAPINEAU
K012989 09/06/2001 DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070 DOLPHIN MEDICAL INC. BILL CURNAN
K013142 09/20/2001 DIASUS DYNAMIC IMAGING LTD. ALLEN FINDLAY
K012957 09/04/2001 TOWEL DRAPE, MODELS 4409, 4410 DYNAREX CORP. JOHN GAGLIARDI
K013219 09/26/2001 PROTOCO2L INSUFFLATOR MODEL 6400 E-Z-EM, INC. ROBERT WILLIAMS
K013088 09/17/2001 ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS ECHOTECH 3D IMAGING SYSTEMS, INC. KEVIN MORNINGSTAR
K013152 09/20/2001 ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS ELAN HOLDINGS, INC. WYNN STOCKING
K013255 09/28/2001 SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF ELLMAN INTL., INC. FRANK LIN
K012958 09/04/2001 BREATHING CIRCUIT FILTER EMERGENCY FILTRATION PRODUCTS, INC. DOUGLAS K BEPLATE
K013191 09/24/2001 PASS SPINAL SYSTEM ENCORE ORTHOPEDICS, INC. JOANNA DROEGE
K012977 09/05/2001 VARICES INJECTION NEEDLE ENDO-THERAPEUTICS, INC. TODD ADKISSON
K013122 09/19/2001 EMS ELECTROSTATIC FLITER AND HME COMBINATION ENGINEERED MEDICAL SYSTEMS PAUL DRYDEN
K013089 09/17/2001 EMS HEPA FILTER AND HME COMBINATIONS ENGINEERED MEDICAL SYSTEMS PAUL DRYDEN
K013123 09/19/2001 EMS PULMONARY FUNCTION TESTING FILTER ENGINEERED MEDICAL SYSTEMS PAUL DRYDEN
K013226 09/27/2001 EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT EVENFLO COMPANY, INC. MATTHEW G MCCARTY
K013116 09/18/2001 DURQ/ QUALIDURA EVER-SAFETY TECHNICAL SERVICE DANIEL YANG
K013211 09/26/2001 MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS EXACTECH, INC. ROBERT PAXSON
K013037 09/10/2001 EXCEL A.V FISUTAL NEEDLE SET EXELINT INTL. CO. ARMAND HAMID
K013229 09/27/2001 LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE FERRANIA USA, INC. DOUG HALE
K013118 09/18/2001 MODIFICATION TO ALPHA DX SYSTEM FIRST MEDICAL, INC. GREG HOLLAND
K012947 09/04/2001 SMARTFLOW FLORENCE MEDICAL LTD. SHOSHANA FRIEDMAN
K013067 09/12/2001 FRIALOC DENTAL IMPLANT SYSTEM FRIADENT GMBH CAROL PATTERSON
K013218 09/26/2001 FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II FUJIFILM MEDICAL SYSTEM U.S.A., INC. JOSEPH M AZARY
K013198 09/25/2001 FUJI VII CAPSULE GC AMERICA, INC. TERRY L JORITZ
K012970 09/04/2001 GE SIGNA ASSET IMAGING OPTION GE MEDICAL SYSTEMS LARRY KROGER
K013136 09/19/2001 ANEURYSM CLIPS GISTLSTRASSE DIETER VON SEPPELIN
K012976 09/05/2001 TWIN PLUS GRASS-TELEFACTOR DIVISON JOHN B CHATTEN
K013026 09/10/2001 POWDERED LATEX EXAMINATION GLOVES GREAT GLOVE (THAILAND) CO. LTD. KM LEE
K013092 09/17/2001 HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING GUIDANT CORP. JENNIFER P RIGGS
K013069 09/13/2001 BIOSPEED H.S. HOSPITAL SERVICES S.P.A. LUCIO IMPROTA
K013070 09/13/2001 JAMSHIDI BIOPSY NEEDLE H.S. HOSPITAL SERVICES S.P.A. LUCIO IMPROTA
K013071 09/13/2001 SECURCUT ASPIRATION BIOPSY NEEDLE H.S. HOSPITAL SERVICES S.P.A. LUCIO IMPROTA
K013108 09/17/2001 BIOSUC HAKKO MEDICAL CO., LTD. MSHIRO KITAGAWA
K013109 09/17/2001 SONOPSY HAKKO MEDICAL CO., LTD. SHIRO JITAGAWA
K013033 09/10/2001 MODIFICATION TO: HL168W TOUCH SCREEN HEALTH & LIFE CO., LTD. PAUL YANG
K013253 09/28/2001 HISONIC-TRD TINNITUS RELIEF DEVICE HEARING INNOVATIONS, INC. GERARD J PRUD'HOMME
K013078 09/14/2001 ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 HELENA LABORATORIES PATRICIA FRANKS
K013141 09/20/2001 MICROGYN PLUS STIMULATION DEVICE HOLLISTER, INC. JOSEPH S TOKARZ
K013106 09/17/2001 2 PIECE MODULAR HIP STEM HOWMEDICA OSTEONICS CORP. WILLIAMR J CYMBALUK
K012956 09/04/2001 HYGIA HEALTH SERVICES REPROCESSED NU TECH COMBO, MODEL LEFT LIMB AND RIGHT LIMB HYGIA HEALTH SERVICES, INC. GEOFF M FATZINGER
K013213 09/26/2001 HYPERION VISIQUANT ANA TEST KIT HYPERION, INC. RADHA GOOLABSINGH
K013060 09/11/2001 ICS MEDICAL MODEL VG-30 VIDEO GOGGLES ICS MEDICAL ROBERT M SIMENSON
K013039 09/10/2001 INION CPS 2.0 ORTHOGNATHIC PLATE INION LTD. HANNA MARTTILA
K013005 09/06/2001 ACT 11 MP VENTRICULAR CATHETER INNERSPACE, INC. DONALD E BOBO
K012964 09/04/2001 56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM INNOLATEX SDN. BHD CHANG AH-KAU
K012962 09/04/2001 DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM INNOLATEX SDN. BHD CHANG AH-KAU
K013021 09/07/2001 LIGHTLANCE LASER SKIN PERFORATOR INNOTECH USA, INC. HOWARD HOLSTEIN
K013017 09/07/2001 MEDIGROUP KEY TUBE JANIN GROUP, INC. JOHN A NAVIS
K013107 09/17/2001 BIOABSORBABLE INTERFERENCE SCREW MEGAFIX KARL STORZ ENDOSCOPY JAMES A LEE
K012946 09/04/2001 SUNLITELED MODEL #2810 KINETIC INSTRUMENTS, INC. WILLIAM J BECKER
K013054 09/11/2001 KONICA DIRECT DIGITIZER REGIUS MODEL 350 KONICA MINOLTA MEDICAL & GRAPHIC, INC. KOJI KUBO
K013052 09/11/2001 KONICA LASER IMAGER, DRYPRO MODEL 751/752 KONICA MINOLTA MEDICAL & GRAPHIC, INC. KOJIICHI KUBO
K013197 09/25/2001 WS-501 HEAT LAMP LHASA MEDICAL, INC. KYUNG P RIIHIMAKI
K013131 09/19/2001 BIOSCREW XTRALOK LINVATEC CORP. LAURA D SENEFF
K013117 09/18/2001 RESECTION ABLATOR LINVATEC CORP. LAURA D SENEFF
K013223 09/27/2001 PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM (PVOCS) LITTON SYSTEMS, INC. GARY BYRD
K013119 09/18/2001 VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006 MAINE STANDARDS CO. CHRISTINE BEACH
K012992 09/06/2001 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIES OF SENSORS AND CABLES MASIMO CORP. JAMES J CRONIN
K013239 09/28/2001 COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES MED GEN, INC. THEODORE BARASH
K013244 09/28/2001 COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE MED GEN, INC. THEDORE BARASH
K013225 09/27/2001 INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE MEDAFOR, INC. PHILIP B JARVI
K013120 09/18/2001 PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18 MEDAMICUS, INC. DENNIS S MADISON
K013162 09/21/2001 14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH SPLIT-CATH, 14FX36CM ASH SPLIT-CATH, 14F X 40CM ASH MEDCOMP JEANNE M CUSH
K012994 09/06/2001 WIZAIR DVT MEDICAL COMPRESSION SYSTEMS (DBN) LTD. SHOSHANA FRIEDMAN
K012979 09/05/2001 COMPRESSIBLE LIMB SLEEVE MEDICAL DEVICE SERVICES, INC. RON EAMES
K013098 09/17/2001 KIMAX REMOTE VIEWING STATION MEDICAL METRICS, INC. ANN TUNSTALL
K012944 09/04/2001 POWER DRIVE MEDITEAM AB THOMAS STJERNKVIST
K013082 09/14/2001 MEDSTAR 100 INTERFERENTIAL STIMLATOR MEDNET SERVICES, INC. DAVID L MATHEWS
K013081 09/14/2001 MEDSTAR 150 MEDNET SERVICES, INC. DAVID L MATHEWS
K012950 09/04/2001 MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM MEDRAD, INC. LORRAINE R FREDES
K012969 09/04/2001 DOUBLE SPRINGERS NONOXNOL 9 CONDOM MEDTECH PRODUCTS LTD. A. V. K. REDDY
K013013 09/07/2001 MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR. MEDTRONIC CARDIAC SURGICAL PRODUCTS ROGER W BRINK
K013063 09/12/2001 GRIP LOCK ANCHOR, MODEL 411374 MEDTRONIC NEUROLOGICAL MONAYA LEE
K013000 09/06/2001 MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520 MEDTRONIC NEUROSURGERY JANET MCAULEY
K013084 09/14/2001 AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T MEDTRONIC PERFUSION SYSTEMS MARIE HOLM
K013014 09/07/2001 BLOCK CEMENT RESTRICTOR (CR) - TITANIUM MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE
K012953 09/04/2001 GIOTTO IMAGE MEDX, INC. FLOYD R ROWAN
K013192 09/25/2001 SONICATOR PLUS 930, MODEL ME 930 METTLER ELECTRONICS CORP. ROBERT E FLEMING
K013205 09/25/2001 MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 MILLAR INSTRUMENTS, INC. MONICA R MONTANEZ
K013228 09/27/2001 3M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR MINNESOTA MINING AND MFG. CO. TIERNEY NORSTED
K013040 09/10/2001 LIGHT SABER INTRODUCER NEEDLE MINRAD, INC. HOWARD M HOLSTEIN
K013047 09/10/2001 FOTONA DUALIS ND:YAG LASER SYSTEM, FOTONA TWINLIGHT ND:YAG LASER SYSTEM MOJCA VALIJAVEC MOJCA VALJAVEC
K013159 09/21/2001 HRH-63-8 HEAD ARRAY COIL MRI DEVICES CORP. TOM SCHUBERT
K013099 09/17/2001 MODIFICATION TO: QWH-420 WRIST ARRAY COIL MRI DEVICES CORP. TOM SCHUBERT
K013163 09/21/2001 UNIGLOVE LANO-E POWDER-FREE LATEX EXAMINATION GLOVES N.S. UNI-GLOVES SDN. BHD. ROBERT D VANDER LEEK
K013053 09/11/2001 MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING NANMA MFG CO., LTD. YOLANDA SMITH
K013113 09/18/2001 MODIFICATION TO NANMA VACUUM PUMP NANMA MFG CO., LTD. YOLANDA SMITH
K013051 09/11/2001 NANMA ADJUSTABLE CONSTRICTION RING NANMA MFG CO., LTD. YOLANDA SMITH
K013212 09/25/2001 WAVELENGHT ULTRASOUND LOTION NATIONAL THERAPY PRODUCTS INC. PAUL L HOOEY
K013137 09/19/2001 ALGO 3 NEWBORN HEARING SCREENER NATUS MEDICAL, INC. SHEILA RAMERMAN
K013024 09/07/2001 SELECTIVA GUIDEWIRE NEO METRICS, INC. GENE CHAMPEAU
K012982 09/05/2001 COOLTOUCH VARIZOOM NEW STAR LASERS, INC. DONALD V JOHNSON
K013167 09/21/2001 MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500 NEWCARE PRODUCTS, LLC. T. WHIT ATHEY
K013036 09/10/2001 NOMOS MOTORIZED CRANE II NOMOS CORP. FRANCIS X DOBSCHA
K013133 09/19/2001 NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116 NORDIX, INC. MARIAN LISAK
K013185 09/24/2001 TCM ENDO III NOUVAG AG COLLEEN BOSWELL
K013215 09/26/2001 MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM NUVASIVE, INC. SEAN M CURRY
K013066 09/12/2001 HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE OLYMPUS AMERICA, INC. LAURA STORMS-TYLER
K013094 09/17/2001 ORTHOSONIX ENERGEX ORTHOSONIX, INC. RUSSELL PAGANO
K013006 09/06/2001 OVUS CAPLESS SAFETY NEEDLE OVUS SYSTEMS T. WHIT ATHEY
K013041 09/10/2001 PLEXOLONG SETS PAJUNK GMBH BURK A BRANDT
K013093 09/17/2001 PALL ULTIPOR ANESTHESIA BREATHING SYSTEM PALL MEDICAL LEONARD S BERMAN
K013028 09/10/2001 PALOMAR SLP 1000 PALOMAR MEDICAL PRODUCTS, INC. MARCY MOORE
K013199 09/25/2001 PHILIPS COMPONENT COMPACT MONITOR,MODEL M1275B, PHILIPS COMPENENT RACK, MODEL M1276B PHILIPS MEDICAL SYSTEMS, INC. DAVE OSBORN
K012987 09/06/2001 PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER PHOENIX DIAGNOSTICS, INC. RAM NUNNA
K013220 09/26/2001 HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS) POLY VUE TECHNOLGIES, INC. MARTIN DALSING
K013203 09/25/2001 BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS POLYMER TECHNOLOGY SYSTEMS, INC. MARGO ENRIGHT
K013173 09/24/2001 BIOSCANNER PLUS; LIPID PANEL TEST STRIPS POLYMER TECHNOLOGY SYSTEMS, INC. MARGO ENRIGHT
K013038 09/10/2001 SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010 POLYSTAN A/S DANA OLSEN
K013172 09/24/2001 PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, "OVER THE GUIDE" TIP, MODEL PORGES S.A. BERNARD ISMAEL
K013174 09/24/2001 PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL, PORGES S.A. BERNARD ISMAEL
K012974 09/05/2001 PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007 PRIZM MEDICAL, INC. CATHRYN N CAMBRIA
K013200 09/25/2001 RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01 RENNELS MEDICAL CORP. DAVID LEE
K013027 09/10/2001 MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123 RESPIRONICS HEALTHSCAN, INC. SUSAN D GOLDSTEIN-FALK
K013129 09/19/2001 RHODIA DENTAL PUTTY IMPRESSION MATERIAL RHODIA INC. ALAIN MORIN
K013140 09/19/2001 RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL RHODIA INC. ALAIN MORIN
K013206 09/25/2001 TINA-QUANT APOLIPOPROTEIN B VER.2 ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K013207 09/25/2001 TINA-QUANT APOLIPOPROTEIN B VER.2 ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K013249 09/28/2001 TINA-QUANT APOLIPOPROTEIN VER.2 ROCHE DIAGNOSTICS CORP. HELEN T TORNEY
K012966 09/04/2001 ROCHE COBAS TAQMAN ANALYZER ROCHE MOLECULAR SYSTEMS, INC. GARY S RIORDAN
K013121 09/18/2001 MT ALERT INFUSION MONITOR SIERRA BIOSEARCH INC RICHARD CITRENAUM
K013056 09/11/2001 GELCLAIR CONCENTRATED ORAL GEL SINCLAIR PHARMACEUTICALS, LTD. PRISCILLA COX
K012949 09/04/2001 URETEX SUP PUBOURETHRAL SLING SOFRADIM PRODUCTION MARY MCNAMARA-CULLINANE
K013170 09/24/2001 SCANTAC MEMBRANE OR SCANTAC STRIP SONOTECH, INC. MARGARET J LARSON
K013090 09/17/2001 SOPRO 67D OPERATING ROOM CAMERA SOPRO PIERRE MONTILLOT
K013046 09/10/2001 COSMOS SYSTEM SPACELABS MEDICAL, INC. EDWARD M BASILE
K013196 09/25/2001 ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM SPINAL INNOVATIONS, LLC. KENNETH RUSSELL
K013160 09/21/2001 POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER SPIRE BIOMEDICAL INC DONALD FICKETT
K013029 09/10/2001 SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515 ST. JUDE MEDICAL JIM M TAUFEN
K013139 09/19/2001 STELLARTECH COAGULATION SYSTEM STELLARTECH RESEARCH CORP. JAMES R SANTOS
K013242 09/28/2001 AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM STERIS CORPORATION ROBERT H MCCALL
K013104 09/17/2001 SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE STERLING MEDIVATIONS, INC. JOEL DOUGLAS
K013059 09/11/2001 STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES) STONY BROOK SURGICAL INNOVATIONS, INC. SUSAN D GOLDSTEIN-FALK
K012991 09/06/2001 NEPTUNE WASTE MANAGEMENT STSTEM STRYKER INSTRUMENTS SUZANNE VELAZQUEZ
K013022 09/07/2001 SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS SULZER CARBOMEDICS, INC. LISA PETERSON
K013227 09/27/2001 SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT SULZER DENTAL, INC. FOSTER BOOP
K013031 09/10/2001 MOST OPTIONS SYSTEM SULZER ORTHOPEDICS, INC. FRANCES E HARRISON
K012961 09/04/2001 SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM SULZER ORTHOPEDICS, INC. MITCHELL A DHORITY
K013132 09/19/2001 SIGN IM NAIL SURGICAL IMPLANT GENERATION NETWORK (SIGN) DOUG DONNELLY
K013009 09/06/2001 BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2 SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K013007 09/06/2001 BELLEGLASS HP ENAMEL 2 SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K013008 09/06/2001 NEXUS 2 MODIFIED SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K013072 09/13/2001 CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP) SYNTHES THOMAS M MARGUIRE
K012945 09/04/2001 SYNTHES 2.4 MM CANNULATED SCREW SYNTHES (USA) MATTHEW M HULL
K013044 09/10/2001 SYNTHES 3.9 MM PELVIC SCREWS SYNTHES (USA) MATTHEW M HULL
K013248 09/28/2001 SYNTHES LCP DISTAL TIBIA PLATES SYNTHES (USA) MATTHEW M HULL
K013061 09/11/2001 BIOTOUCH MASSAGE THERAPY SYSTEM TACTILE SYSTEMS TECHNOLOGY INC ERIC MCKEE
K013164 09/21/2001 SURSHIELD SAFETY WINGED BLOOD COLLECTION SET TERUMO MEDICAL CORP. BARBARA SMITH
K013034 09/10/2001 MODIFICATION TO: THERMACOOL IIA THERMAGE, INC. PAMELA M BUCKMAN
K013202 09/25/2001 MODIFICATION TO BRAIDED GUIDING INTRODUCER THOMAS MEDICAL PRODUCTS, INC. TIM STOUDT
K013016 09/07/2001 TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE TILLOTSON HEALTHCARE CORP. F. W PERRELLA
K013254 09/28/2001 POLYCOAT POWDERED LATEX EXAMINATION GLOVE WITH ALOE VERA & PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) TOP QUALITY MFG., INC. ART WARD
K013214 09/26/2001 CEREBRAL BLOOD FLOW ANALYSIS SYSTEM (CBP), MODEL NUMBER CSCP-001A TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K013195 09/25/2001 HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K013075 09/14/2001 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K013086 09/14/2001 WET LIGHT PERSONAL MOISTURIZER TRIGG LABORATORIES, INC. W. PATRICK NOONAN
K013150 09/20/2001 MR-GUIDE 2000 ULTRAGUIDE LTD. GEORGE MYERS
K013146 09/20/2001 VIATRONIC V3D CALCIUM SCORING VIATRONIX, INC. SUSAN D GOLDSTEIN-FALK
K013091 09/17/2001 ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM VON ZEPPELIN GMBH DIETER VON ZEPPELIN
K013250 09/28/2001 GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT W. L. GORE & ASSOCIATES, INC. TIMOTHY J RYNN
K013101 09/17/2001 WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA WIENER LABORATORIES S.A.I.C. VIVIANA CETOLA
K013102 09/17/2001 WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002 WIENER LABORATORIES S.A.I.C. VIVIANA CETOLA
K013145 09/20/2001 WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR. WIENER LABORATORIES S.A.I.C. VIVIANA CETOLA
K013097 09/17/2001 WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003 WIENER LABORATORIES S.A.I.C. VIVIANA CETOLA
K013095 09/17/2001 WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311 WIENER LABORATORIES S.A.I.C. VIVIANA CETOLA
K013035 09/10/2001 GUARDIAN LIMB SALVAGE SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
K013025 09/10/2001 MODIFICATION TO FLOUROLAB PLUS Z-KAT, INC. WILLIAM F TAPIA


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact