FDA 510(k) Decisions During March, 2002  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K004009 03/25/2002 3M ATTEST 290 AUTO-READER 3M COMPANY STEPHAN NORSTED
K020256 03/25/2002 UNICEM 3M ESPE AG DENTAL PRODUCTS ANDREAS PETERMANN
K012998 03/13/2002 AMPHETAMINE/METHAMPHETAMINE ABBOTT LABORATORIES ALICIA SIMPSON
K012996 03/20/2002 BARBITURATES ABBOTT LABORATORIES LINDA MORRIS
K013143 03/13/2002 BENZODIAZEPINES ABBOTT LABORATORIES LINDA MORRIS
K013247 03/13/2002 CANNABINOIDS ABBOTT LABORATORIES LINDA MORRIS
K013004 03/13/2002 COCAINE ABBOTT LABORATORIES ALICIA SIMPSON
K013001 03/20/2002 METHADONE ABBOTT LABORATORIES ALICIA SIMPSON
K013314 03/13/2002 OPIATES ABBOTT LABORATORIES ALICIA SIMPSON
K013096 03/13/2002 PHENCYCLIDINE ABBOTT LABORATORIES LINDA MORRIS
K013100 03/20/2002 PROPOXYPHENE ABBOTT LABORATORIES LINDA MORRIS
K012983 03/13/2002 ACIST 4 FRENCH ANGIOGRAPHIC CATHETER ACIST MEDICAL SYSTEMS, INC. CARL M BEAURLINE
K013987 03/01/2002 REPROCESSED DISPOSABLE TROCARS ADVEN MEDICAL MARK W ALDANA
K011030 03/01/2002 AESCULAP -MIETHKE SHUNT SYSTEM AESCULAP, INC. JOYCE THOMAS
K014172 03/19/2002 NELSON ELECTROSURGICAL UNIT, MODEL GN640 AESCULAP, INC. LISA MILLINGTON
K014149 03/18/2002 PAEDISCOPE, MODEL # P010A AND PF011A AESCULAP, INC. GEORG KELLER
K014207 03/21/2002 REPOSABLE INSTRUMENT SYSTEM, MODELS MF001-MF083 AESCULAP, INC. LISA MILLINGTON
K020324 03/13/2002 LIFESTYLE OXYGEN CONCENTRATOR AIRSEP CORP. CHARLOTTE H HAMILTON
K010131 03/26/2002 PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB AKSYS, LTD. JAN L ZORN
K014081 03/05/2002 AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGES AKTINA MEDICAL PHYSICS CORP. JOAN KACHAROPOULOS
K020593 03/18/2002 CONVERTORS SMS POLYOLEFIN GOWN ALLEGIANCE HEALTHCARE CORP. SHARON ROBBINS
K020536 03/15/2002 GAZELLE WHEELCHAIR ALUM CREEK WHEELCHAIR CO., INC. RICHARD ROY
K014101 03/20/2002 RAPIDONE-OXY TEST AMERICAN BIO MEDICA CORP. HENRY WELLS
K013318 03/08/2002 ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 AMERICAN DIAGNOSTICA, INC. JOHN BERRYMAN
K013168 03/07/2002 IMUBIND PLASMA PAI-1 ELISA,MODEL 822 AMERICAN DIAGNOSTICA, INC. JOHN B BERRYMAN
K013492 03/13/2002 IMUBIND TPA ELISA, MODEL 860 AMERICAN DIAGNOSTICA, INC. JOHN B BERRYMAN
K020663 03/28/2002 MODIFICATION TO SPARC SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC. MARK MCINTYRE
K020446 03/13/2002 MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM AMERICAN MEDICAL SYSTEMS, INC. ELSA A LINKE
K012796 03/14/2002 AMLUCK AUTOMATIC DIGITAL WRIST, BLOOD PRESSURE MONITOR AK-3000/AK-4000 AMLUCK, INC. YANG TIEN-HSING
K012189 03/05/2002 ANGELTOUCH VENTED IV ADMINISTRATION SET ANGIPLAST PRIVATE LTD. ASHIT B SHAH
K020359 03/06/2002 ULTRA TOUCH POWDERED LATEX EXAMINATION GLOVES AR ALLIANCE HEALTHCARE SDN. BHD. CHUA CHOON CHUAN
K013433 03/05/2002 TROJAN PASSION BERRY GEL ARMKEL LLC STEPHEN C KOLAKOWSKY
K014155 03/18/2002 OPENING/CLOSING WEDGE OSTETOMY PLATES ARTHREX, INC. ANN WATERHOUSE
K020622 03/28/2002 ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000); ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; AND WANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K020557 03/21/2002 ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS ARTHROCARE CORP. BRUCE PROTHRO
K020621 03/28/2002 ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K014290 03/28/2002 ENTEC PLASMA WANDS ARTHROCARE CORP. BRUCE PROTHRO
K014305 03/29/2002 RESORBABLE LACTOSORB-L ACL CROSSPIN ARTHROTEK, INC. SARA B SHULTZ
K014057 03/08/2002 DERMASTAR ER:YAG LASER SYSTEM ASCLEPION-MEDITEC AG WILLIAM KELLEY
K020137 03/04/2002 AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON ASEPTICO, INC. GRANT RAMALEY
K020156 03/06/2002 DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T AXIS-SHIELD DIAGNOSTICS, LTD. EILEEN MCCAFFERTY
K020485 03/12/2002 ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML BAXTER HEALTHCARE CORP. MARY KONKOWSKI
K020806 03/27/2002 ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY BAYER CORP. THOMAS F FLYNN
K020217 03/15/2002 ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K014075 03/07/2002 BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145 BAYLIS MEDICAL CO., INC. KRIS SHAH
K020523 03/20/2002 BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757 BD PASQUALE AMOTO
K020521 03/01/2002 MODIFICATION TO VIGIL LIPID CONTROL BECKMAN COULTER, INC. GAIL LEFEBVRE
K020322 03/27/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM BECTON, DICKINSON & CO. BRADFORD M SPRING
K020068 03/04/2002 SONOREAL 3D SYSTEM BIO MEDI COM COLLEEN DENSMORE
K012960 03/08/2002 BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR BIOGENEX LABORATORIES GURVINDER S NANDA
K020645 03/15/2002 MODIFICATION TO THE MAESTRO SYSTEM BIOHORIZONS IMPLANT SYSTEMS, INC. DONALD E DALTON
K020870 03/25/2002 VITEK 2 ANTIMICROBIAL SUSCEPTIBILITY TEST SYTEM FOR SPARFLOXACIN BIOMERIEUX, INC. NANCY WEAVER
K020871 03/29/2002 VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN BIOMERIEUX, INC. NANCY WEAVER
K020580 03/22/2002 X-SERIES BI-METRIC HIP FEMORAL COMPONENTS BIOMET, INC. PATRICIA S BERES
K014000 03/11/2002 VISTITOME 20-10 MICROKERATOME BIOVISION AG DAVID S FERNQUIST
K014195 03/19/2002 KAYAK HYDROPHILIC GUIDE WIRES BOSTON SCIENTIFIC CORP. MARK MURPHY
K014109 03/12/2002 IN-TIME RETRIEVAL DEVICE BOSTON SCIENTIFIC, TARGET SETH A SCHULMAN
K004022 03/26/2002 M3 (MIRCO-MULTILEAF COLLIMATOR BRAINLAB AG STEFAN VILSMEIER
K012448 03/14/2002 VECTORVISION TRAUMA BRAINLAB AG RAINER BIRKENBACH
K014280 03/20/2002 LATEX EXAMINATION GLOVE (POWDERED) BRIGHTWAY GLOVES PVT. LTD. N. PARAMASIVAN
K014279 03/20/2002 LATEX EXAMINATION GLOVES (POWDER FREE) BRIGHTWAY GLOVES PVT. LTD. N. PARAMASIVAN
K020470 03/08/2002 MODIFICATION TO CORLINK AUTOMATED ANASTOMOTIC DEVICE BYPASS LTD. JONATHAN S KAHAN
K020702 03/29/2002 O'REGAN DISPOSABLE ANOSCOPE CANADIAN THEATRE PRODUCTS LTD. ANN-MARIE O'KEEFE
K012520 03/27/2002 GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E CARDIAC ASSIST DEVICES, INC. RASSOLL RASHIDI
K013201 03/18/2002 CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR CARDIOFOCUS, INC. JOHN GREENBAUM
K020437 03/15/2002 CLASSIC TENS CARE REHAB, INC. CHRISTIAN HUNT
K020233 03/14/2002 CHASE CARDIOVASCULAR PATCH KIT CHASE MEDICAL, INC. DAVE HERNON
K020241 03/13/2002 QACA IGG/IGM ELISA KIT CHESHIRE DIAGNOSTICS LTD. NEIL B STRINGER
K013949 03/27/2002 UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR CHURCHILL MEDICAL SYSTEMS, INC. KETIH PALUCH
K020544 03/12/2002 WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA CHURCHILL MEDICAL SYSTEMS, INC. KEITH PALUCH
K014236 03/26/2002 CLINICON WAVEGUIDE PLATFORM WITH INTERCONNECT FOR LUXAR ACCESSORIES CLINICON CORP. SEAN M CURRY
K014153 03/15/2002 COAPT SYSTMES ENDOTINE DEVICE COAPT SYSTEMS, INC. JUDE PAGANELLI
K013714 03/28/2002 CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP CODAN US CORP. MARILYN R POURAZAR
K020667 03/28/2002 CODMAN HAKIM SHUNT SYSTEMS CODMAN & SHURTLEFF, INC. ELIZABETH DOLAN
K020451 03/14/2002 COMFORT WHEELCHAIRS COMFORT ORTHOPEDIC CO. LTD. ERIC LEE
K013551 03/28/2002 ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM COMPUTER MOTION, INC. DAVID U THOMAS
K020490 03/28/2002 PBS, PBSW WITH CATIONS AND PHENOL RED CONCEPTION TECHNOLOGIES GRACE HOLLAND
K020237 03/19/2002 IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3 CONSOLIDATED TECHNOLOGY CANDICE BETZ
K014035 03/07/2002 "COOLTOUCH" AND "COOLTOUCH-II" ND:YAG LASER SYSTEMS COOLTOUCH CORP. DONALD V JOHNSON
K020316 03/20/2002 CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR; MODELS 466-P306AU & 466-P306BU CORDIS CORP. KAREN WILK
K014041 03/07/2002 TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM CORDIS NEUROVASCULAR ALINA CARABALLO
K020680 03/27/2002 PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS CORDIS NEUROVASCULAR, INC. MARITZA CELAYA
K012377 03/11/2002 OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES CORIN U.S.A. JOEL BATTS
K014262 03/26/2002 COSMED QUARK C12/QUARK T12 COSMED S.R.L. ROBERT SCHIFF
K014156 03/18/2002 CERASORB ORTHO CURASAN AG ERIC WIECHERT
K014216 03/21/2002 SECCA SYSTEM CURON MEDICAL, INC. JONATHAN S KAHAN
K020160 03/14/2002 DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLIN DADE BEHRING, INC. CYNTHIA VAN DUKER
K020162 03/14/2002 DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLIN DADE BEHRING, INC. CYNTHIA VAN DUKER
K020441 03/28/2002 EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY DADE BEHRING, INC. KATHLEEN A DRAY-LYONS
K020142 03/14/2002 MICROSCAN SYNERGIES PLUS DADE BEHRING, INC. MAUREEN MENDE
K020248 03/14/2002 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TRIMETHOPRIM/SULFAMETHOXAZOLE (0.25/4.75-64/1216 UG/ML) DADE BEHRING, INC. MAUREEN MENDE
K020037 03/22/2002 DRIED GRAM NEGATIVE MIC/COMBO PANELS DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K020511 03/06/2002 MICROSCAN SYNERGIES PLUS DADE MICROSCAN, INC. MAUREEN MENDE
K020479 03/26/2002 DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AND ACCESSORIES DATEX-OHMEDA JOEL C KENT
K020310 03/20/2002 DAVLITE MICROENDOSCOPE & ACCESSORIES DAVLITE TECHNOLOGIES DAVID A MCNALLY
K013359 03/08/2002 LP(A)-LATEX SEIKEN ASSAY KIT DENKA SEIKEN'S YOUSUKE MEGURO
K011400 03/27/2002 MRSA-SCREEN DENKA SEIKEN'S KEVIN MANGAN
K014188 03/15/2002 NEW PROPHY POWDER DENTSPLY INTL. P. JEFFERY LEHN
K014053 03/08/2002 CONDUIT TCP GRANULES DEPUY ACROMED KAREN F JURCZAK
K020522 03/21/2002 MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM DEPUY ACROMED KAREN F JURCZAK
K013984 03/28/2002 IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K020128 03/01/2002 ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500 DIAGNOSTIC SYSTEMS LABORATORIES, INC. CARROLL POTTS
K020596 03/23/2002 CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS DIAMOND DIAGNOSTICS, INC. LINDA STUNDTNER
K014030 03/26/2002 1,25-DIHYDROXYVITAMIN D125I RIA DIASORIN, INC. DAVID IKEDA
K014072 03/08/2002 FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH) DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. JONATHAN S KAHAN
K012535 03/01/2002 DRG DISPOSABLE VAGINAL SPECULUM DOCTOR'S RESEARCH GROUP, INC. RICHARD DESLAURIERS
K012989 03/20/2002 DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070 DOLPHIN MEDICAL INC. BILL CURNAN
K020526 03/19/2002 MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR DON WILSON/WILSON-COOK MEDICAL, INC. MARGARET J POSNER
K012957 03/06/2002 TOWEL DRAPE, MODELS 4409, 4410 DYNAREX CORP. JOHN GAGLIARDI
K020635 03/21/2002 KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622; KODAK DIRECTVIEW CR 900 SYSTEM, CATALOG# 1170976 EASTMAN KODAK COMPANY SUSAN PATE
K020403 03/08/2002 MODIFICATION TO EBI XFIX DFS OPTIROM ELBOW FIXATOR EBI, L.P. PATRICIA FLOOD
K014276 03/01/2002 MODIFICATION TO EBI XFIX DFS SYSTEM EBI, L.P. FREDERIC TESTA
K014052 03/08/2002 EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL EDWARDS LIFESCIENCES, LLC. JASON SMITH
K014054 03/08/2002 EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL EDWARDS LIFESCIENCES, LLC. JASON SMITH
K014090 03/11/2002 ENDIUS SPINAL FIXATION SYSTEM ENDIUS, INC. GENE DIPOTO
K013680 03/04/2002 CARBODISSECTING ENDOSCOPE ENDO SURGICAL DEVICES, INC. DEBBIE IAMPIETRO
K013089 03/14/2002 EMS HEPA FILTER AND HME COMBINATIONS ENGINEERED MEDICAL SYSTEMS PAUL DRYDEN
K013123 03/14/2002 EMS PULMONARY FUNCTION TESTING FILTER ENGINEERED MEDICAL SYSTEMS PAUL DRYDEN
K020243 03/05/2002 LASERPRO 16 ERADLINK, INC. ALBERT J KOUBA
K020428 03/04/2002 ENDOPATH DILATING TIP TROCAR, MODEL #512XD ETHICON ENDO-SURGERY, INC. ELIZABETH MILLER
K010761 03/05/2002 SPL-50 SPIROLYSER FIM MEDICAL ERIC DEREI
K014002 03/04/2002 ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 FORTUNE MEDICAL INSTRUMENT CORP. ABE WANG
K013867 03/15/2002 XIVE DENTAL IMPLANT SYSTEM FRIADENT GMBH CAROL PATTERSON
K020342 03/28/2002 UNIFIL FLOW GC AMERICA, INC. TERRY L JORITZ
K020796 03/26/2002 CARD IQ ANALYSIS II GE MEDICAL SYSTEMS LARRY A KROGER
K012915 03/21/2002 DINAMAP PRO 1000 MONITOR, MODEL 1000 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES THOMAS J ENGLISH
K014289 03/28/2002 ORTHOSS RESORBABLE BONE VOID FILLER GEISTLICH-PHARMA PETER S REICHERTZ
K020524 03/20/2002 PATIENTNET MONITORING SYSTEM GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN DIANA M THORSON
K020590 03/20/2002 MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER GETINGE/CASTLE, INC. FREDERICK R CATT
K012869 03/11/2002 GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25 GIMMI GMBH DAGMAR MASER
K020340 03/01/2002 MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING GUIDANT CORP. JENNIFER PAE RIGGS
K020594 03/08/2002 DIEGO POWERED DISSECTOR AND DRILL SYSTEM GYRUS ENT L.L.C. GREGORY SREDIN
K013109 03/12/2002 SONOPSY HAKKO MEDICAL CO., LTD. SHIRO JITAGAWA
K012805 03/13/2002 AUTOMARQER HAMILTON THORNE RESEARCH DIARMAID DOUGLAS-HAMITON
K014164 03/12/2002 GREAT TOE IMPLANT SYSTEM HARMOS ORTHOPAEDICS, INC. RICHARD W WOODS
K020467 03/29/2002 SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452 HELENA LABORATORIES PATRICIA FRANKS
K012045 03/12/2002 HIGHGATE CURVED ROD SYSTEM HIGHGATE ORTHOPAEDICS KAREN E WARDEN
K014240 03/22/2002 PRONTO HITACHI MEDICAL SYSTEMS AMERICA, INC. ROBERT MCCARTHY
K013612 03/19/2002 INCARE PELVIC FLOOR THERAPY SYSTEM HOLLISTER, INC. JOSEPH S TOKARZ
K013653 03/05/2002 INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE HOLLISTER, INC. CINDY ROBERTS
K013871 03/29/2002 LIFEGUARD SAFETY INFUSION SET HORIZON MEDICAL PRODUCTS, INC. PATRICIA D JONES
K020572 03/04/2002 ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM HOWMEDICA OSTEONICS CORP. NANCY J RIEDER
K020677 03/29/2002 GAMMA 3 LAG SCREW HOWMEDICA OSTEONICS CORP. WILLIAM J CYMBALUK
K020650 03/29/2002 MODIFICATION TO REFLEX ANTERIOR CERVICAL PLATE SYSTEM HOWMEDICA OSTEONICS CORP. WILLIAM J CYMBALUK
K020497 03/04/2002 TRIDENT ELEVATED RIM LINER HOWMEDICA OSTEONICS CORP. NANCY J RIEDER
K010744 03/26/2002 FLOWTRON UNIVERSAL, MODEL AC600 HUNTLEIGH HEALTHCARE, INC. AUDRY WITKO
K020660 03/20/2002 HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO I-FLOW CORP. SHANE NOEHRE
K020862 03/26/2002 I-FLOW ELASTOMERIC PUMP I-FLOW CORP. SHANE NOEHRE
K014022 03/04/2002 MRI LINE MARKER I.Z.I. CORP. HELEN ZINREICH
K020223 03/04/2002 INVIGRA INDUS MEDICARE LTD. P. K REDDY
K013005 03/08/2002 ACT 11 MP VENTRICULAR CATHETER INNERSPACE, INC. DONALD E BOBO
K020041 03/14/2002 IALUSET HYDROCOLLOID INSTITUT BIOCHIMIQUE SA (IBSA) CLARENCE E JONES
K020558 03/21/2002 LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE INTEGRA NEUROSCIENCES NANCY MATHEWSON
K020798 03/28/2002 HEMOCHRON JR. SIGNATURE + INTERNATIONAL TECHNIDYNE CORP. JOHN CLAY
K012406 03/26/2002 ACCESS SEQUESTRATION SYSTEM INTERPORE CROSS INTL. PROISE REY-FESSLER
K020898 03/29/2002 D.SIGN 15 (DW286 B) IVOCLAR VIVADENT, INC. ANDERJEET GULATI
K020183 03/13/2002 PISCES PLUS (DW286 C) IVOCLAR VIVADENT, INC. ANDERJEET GULATI
K012849 03/27/2002 GLASS POST J. MORITA USA, INC. KEITH A BARRITT
K020158 03/07/2002 NON-EUGENOL TEMPORARY CEMENT J. MORITA USA, INC. KEITH A BARRITT
K020157 03/04/2002 TEMPORARY CROWN AND BRIDGE MATERIAL J. MORITA USA, INC. KEITH A BARRITT
K014300 03/01/2002 SAFETOUCH JAMES D RUSIN MD, MBA JAMES D RUSIN
K013876 03/04/2002 INFRARED EAR THERMOMETER, MODEL DX-707 JAWON MEDICAL CO., LTD. WON-HEE PARK
K014303 03/26/2002 JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE JOSTRA AG KATHLEEN JOHNSON
K014204 03/05/2002 ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822 K-JUMP HEALTH CO., LTD. JONATHAN S KAHAN
K020091 03/21/2002 OPTILUX 501 KERR CORPORATION (DANBURY) COLLEEN BOSWELL
K020178 03/15/2002 BELLEGLASS HP MODELING GEL KERR DENTAL MATERIALS CENTER COLLEEN BOSWELL
K011590 03/20/2002 RESORB-X RESORBABLE PLATING SYSTEM KLS-MARTIN L.P. ARTHUR WARD
K013054 03/01/2002 KONICA DIRECT DIGITIZER REGIUS MODEL 350 KONICA MINOLTA MEDICAL & GRAPHIC, INC. KOJI KUBO
K014087 03/04/2002 LATEXX MANUFACTURING NON-CHLORINATED, POLYMER COATED, POWDER-FREE RUBBER LATEX EXAMINATION GLOVE LATEXX MANUFACTURING SDN.BHD. YOLANDA SMITH
K020006 03/29/2002 DYNA INTRA-LIMBAL LENS LENS DYNAMICS, INC. AL VASKE
K012825 03/19/2002 HEARTTRENDS LEV-EL, LTD. EINAT SHAMMAI
K020450 03/21/2002 VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108 MAINE STANDARDS CO. CHRISTINE BEACH
K011378 03/25/2002 JOE LUB "HELMET" CONDOM MARKETING SALES CONCEPTS, INC. (MSCI) ERIC J ARTHUR
K011363 03/25/2002 JOE LUBE CONDOM MARKETING SALES CONCEPTS, INC. (MSCI) ERIC J ARTHUR
K020518 03/07/2002 MEDELA SYMPHONY BREAST PUMP, MODEL 024 MEDELA, INC. WERNER FREI
K012994 03/27/2002 WIZAIR DVT MEDICAL COMPRESSION SYSTEMS (DBN) LTD. SHOSHANA FRIEDMAN
K020069 03/18/2002 MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM MEDTRONIC MIDAS REX GREG CANNEDY
K012506 03/07/2002 MASTERGRAFT RESORBABLE CERAMIC GRANULES MEDTRONIC SOFAMOR DANEK USA, INC. RICHARD W TREHARNE
K020632 03/15/2002 ENGUARD REMOTE PATIENT MONITOR MENNEN MEDICAL LTD. EREZ NIMROD
K012414 03/06/2002 PRIME ECG SYSTEM MERIDIAN MEDICAL TECHNOLOGIES, INC. JAMIL F LAHAM
K013779 03/29/2002 THERMOMETER MODELS ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST8542C, AND ST8542F MESURE TECHNOLOGY PHIL ZULUETA
K014060 03/05/2002 MICROAIRE 1000E SYSTEM MICROAIRE SURGICAL INSTRUMENTS, INC. CARL ANGLES
K020725 03/12/2002 MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1 MICROLIFE CORP. SUSAN D GOLDSTEIN-FALK
K014272 03/27/2002 PERIOLASE ND:YAG DENTAL LASER SYSTEM MILLENNIUM DENTAL TECHNOLOGIES, INC. DAVID M HARRIS
K012294 03/04/2002 WRISTORE FIXATOR MILLENNIUM MEDICAL TECHNOLOGIES, INC. DAVID W SCHLERF
K013572 03/14/2002 MITEK BIOCRYL INTERFERENCE SCREWS MITEK PRODUCTS CHRISTINE KUNTZ-NASSIF
K020737 03/21/2002 CAT ACTIVE WHEELCHAIR MOVINGPEOPLE.NET PEGGY SPILIADIS
K020606 03/13/2002 NVA-63-8 NEUROVASCULAR ARRAY COIL MRI DEVICES CORP. TOM SCHUBERT
K020599 03/13/2002 MTP CLEARVISION DISPOSABLE TUBING SET MTP MEDICAL TECHNICAL PROMOTION GMBH JAMES A LEE
K020060 03/05/2002 ASTOFLO NATS CORP. RICHARD C LANZILLOTTO
K012891 03/07/2002 OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA "ACCESSORIES") NELLCOR PURITAN BENNETT, INC. RONALD J EHMSEN
K020031 03/27/2002 EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302 NEOTHERMIA CORP. SHERRIE COVAL-GOLDSMITH
K012575 03/12/2002 PREFERNCE IMRT TREATMENT PLANNING MODULE NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC. LEE MYERS
K014044 03/04/2002 MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT) NOTAL VISION, INC. RICHARD E LIPPMAN
K014251 03/26/2002 NTERO HOTROD SYSTEM NTERO SURGICAL, INC. BOMMI BOMMANNAN
K013353 03/04/2002 NEUROSPECTQUAD GAMMA CAMERA NUCLEAR CARDIOLOGY SYSTEMS, INC. CHARLES H ROSE
K020015 03/13/2002 IMPLANT GUIDANCE SYSTEM APPLICATOR SET NUCLETRON CORP. LISA DIMMICK
K020411 03/12/2002 NUVASIVE TRIAD FACET SCREW SYSTEM NUVASIVE, INC. LAETITIA BERNARD
K011269 03/04/2002 LIFEMATE MLA MULTI-LINE ADAPTOR; LIFEMATE SFR STERILE FLUID RESERVOIR NXSTAGE MEDICAL, INC. KAREN ST. ONGE
K014170 03/04/2002 STAURENGHI WIDE FIELD SCANNING LASER LENS OCULAR INSTRUMENTS, INC. RAYMOND GRAHAM
K014286 03/08/2002 SALUTE, MODEL 3022 ONUX MEDICAL, INC. RUTHANN DEPIETRO
K012852 03/26/2002 EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS OPTONOL, LTD RICHARD E LIPPMAN
K020049 03/18/2002 FORTAFLEX SURGICAL MESH ORGANOGENESIS, INC. PATRIC BILBO
K014189 03/21/2002 ODI TALON INTRAMEDULLARY HIP NAIL ORTHOPEDIC DESIGNS, INC. JOHN SODEIKA
K020669 03/28/2002 PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB OSCOR INC. MILA DOSKOCIL
K014253 03/26/2002 DERMACHILLER 4 PARADIGM TREX, LLC NIKOLAI TANKOVICH
K020239 03/20/2002 TOUCH&BOND-PLUS PARKELL, INC. NELSON J GENDUSA
K020331 03/20/2002 PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. LINDA K DILLON
K011688 03/20/2002 PELVICFLEXER EXERCISE DEVICE PELVICFLEX, INC. SUSAN D GOLDSTEIN-FALK
K014268 03/27/2002 NORAPAD PLAIN; NORAPAD TA PERLEI MEDICAL, INC. ART WARD
K020055 03/15/2002 PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION PHILIPS MEDICAL SYSTEMS LYNN HARMER
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K014302 03/29/2002 UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM PISHARODI SURGICALS, INC. MADHAVEN PISHARODI
K020202 03/12/2002 PLAYTEX DEODORANT TAMPONS, MODEL 34702 PLAYTEX PRODUCTS, INC. MARK ROSENGARTEN
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K012350 03/14/2002 MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL POREX SURGICAL, INC. HOWARD MERCER
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K020269 03/27/2002 PROCERA ALLCERAM BRIDGE MATERIAL PROCERA SANDVIK AB AGNETA ODEN
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K014133 03/14/2002 PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE PULPDENT CORP. KENNETH J BERK
K014138 03/14/2002 PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT PULPDENT CORP. KENNETH J BERK
K013662 03/08/2002 MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS QUANTIMETRIX CORP. GEBHARD NEYER
K020094 03/08/2002 EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN 600-665 AND EN 600-670 MECHANICAL WHEELCHAIRS REGULATORY INSIGHT, INC. KEVIN WALLS
K020100 03/08/2002 SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL WHEELCHAIRS REGULATORY INSIGHT, INC. KEVIN WALLS
K020777 03/20/2002 BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX RESPIRONICS, INC. ZITA A YURKO
K014139 03/21/2002 DIABETES ASSISTANT SOFTWARE ROCHE DIAGNOSTICS CORP. SCOTT THIEL
K020369 03/06/2002 ELECSYS ANTI-TG CALCHECK ROCHE DIAGNOSTICS CORP. SHERRI L COENEN
K020438 03/08/2002 SAS VALUE HCG SA SCIENTIFIC, INC. RICARDO R MARTINEZ
K020605 03/08/2002 SANARUS VISICA TREATMENT SYSTEM SANARUS MEDICAL, INC. VINCENT CUTARELLI
K020881 03/27/2002 MODIFICATION TO PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT SCIENCE INCORPORATED LYNN WEIST
K013931 03/27/2002 OMNI OXYGEN SYSTEM, MODEL 1000 SEQUAL TECHNOLOGIES, INC. PAM JACKSON
K020265 03/08/2002 SERRALENE, MODEL CATALOG NO 1S SERRAL, S.A. DE C.V. SCOTT HENDERSON
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K020573 03/13/2002 MODIFICATION TO MAGNETOM RHAPSODY SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. JAMES YIEH
K013426 03/26/2002 MOONRAY MOBILE C-ARM SIMAD S.R.L. JEFFREY S KEES
K020480 03/12/2002 RBM SMITH & NEPHEW, INC. WILLIAM MCCALLUM
K020159 03/26/2002 SMITH & NEPHEW TWINFIX TI QUICK T SMITH & NEPHEW, INC. WILLIAM MCCALLUM
K012778 03/15/2002 VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE GENESIS KNEE SYSTEM, THE GENESIS II KNEE SYS SMITH & NEPHEW, INC. DAVID HENLEY
K012787 03/15/2002 VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE REFLECTION ACTABULAR SYSTEM (ACETABULAR LINE SMITH & NEPHEW, INC. DAVID HENLEY
K012788 03/15/2002 VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE COFIELD TOTAL SHOULDER SYSTEM, THE NEER II SMITH & NEPHEW, INC. DAVID HENLEY
K013488 03/27/2002 SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8 SOPHYSA SA JACQUELINE E MASSE
K020270 03/14/2002 SOPRO 367D 3CCD FULL DIGITAL ENDOSCOPY CAMERA SOPRO PIERRE MONTILLOT
K020611 03/27/2002 UNIVERSAL BONE PLATE III SYSTEM (UBP III) SPINAL CONCEPTS, INC. DAVID M HOOPER
K020659 03/29/2002 DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT SSL AMERICAS, INC. JOYCE NING
K012732 03/04/2002 INTEGRAPH FLASH, MODEL CI 110 STERITEC PRODUCTS, INC. LINDA NELSON
K020391 03/08/2002 STERN MICRO ERA ATTACHMENT SYSTEM STERNGOLD MARIA RAO
K020097 03/15/2002 STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM STRYKER ENDOSCOPY ALISA MILLER
K014263 03/08/2002 NEWGEN/UNIVERSAL MANDIBULAR SYSTEM STRYKER INSTRUMENTS ROBIN L ROWE
K014175 03/20/2002 SULZER DENTAL CERAMIC SYSTEM-HEXLOCK SULZER DENTAL, INC. SEAN HARIRI
K014214 03/19/2002 SULZER DENTAL CERAMIC SYSTEM-SPLINE SULZER DENTAL, INC. SEAN HARIRI
K020136 03/20/2002 VISUALINE BARBITURATES DIPSTRIP TEST SUN BIOMEDICAL LABORATORIES, INC. MING SUN
K014230 03/13/2002 STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) SUPERMAX GLOVE MANUFACTURING SDN BHD STANLEY THAI
K013774 03/05/2002 CHLORINATED POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH ALOE VERA SUPERMAX SDN BHD PRISCILLA WEE
K011588 03/28/2002 SURETONE SURETONE INTERNATIONAL MARYNA BURKE
K020973 03/29/2002 EX-308 EXCIMER LASER FOR PHOTOTHERAPY TREATMENT OF VITILIGO SURGILIGHT, INC. TIMOTHY SHEA
K020126 03/15/2002 MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX TV SYSTEM) SURX, INC. ALAN CURTIS
K020267 03/29/2002 OPTILUX CURING LIGHTS SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K014197 03/21/2002 SYNTHES HIGH TIBIAL OSTEOTOMY PLATE SYNTHES (USA) MATTHEW M HULL
K020472 03/08/2002 BIOTECH MANUAL WHEELCHAIR B900 SUPER LIGHT WHEELCHAIR TAIWAN ARMADA ENTERPRISE CO., LTD. KE-MIN JEN
K020188 03/08/2002 BIOTECH MANUAL WHEELCHAIR, A1000 SUPER SPORT WHEELCHAIR TAIWAN ARMADA ENTERPRISE CO., LTD. KE-MIN JEN
K020175 03/21/2002 URS-IG (GLUCOSE TEST) TECO DIAGNOSTICS OLIVIA CHEN
K013737 03/01/2002 MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON TELEMED SYSTEMS, INC. MICHAEL CARROLL
K012041 03/28/2002 THE HAMMER MODEL H100 TENACORE HOLDINGS, INC. BRAND CASO
K014260 03/27/2002 TISSUELINK SOLID CYLINDER MONOPOLAR DEVICE TISSUELINK MEDICAL, INC. VICKI ANASTASI
K001638 03/04/2002 O-RING PROSTHETIC ATTACHMENT TITAN IMPLANTS LYNETTE L HOWARD
K013821 03/05/2002 SILK TOUCH POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) TOP QUALITY MFG., INC. MARC SINKOW
K010253 03/19/2002 ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 TRANSONIC SYSTEMS, INC. MARK S ALSBERGE
K020002 03/21/2002 MODEL P-33, BATTERY OPERATED, THREE WHEEL, POWER SCOOTER , MODEL P-33 TRANSWORLD MOBILITY DISTRIBUTION, L.L.C. JUAN C RIVERA
K020001 03/21/2002 PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-3 TRANSWORLD MOBILITY DISTRIBUTION, L.L.C. JUAN C RIVERA
K014259 03/26/2002 SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K014243 03/26/2002 BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL BMCD-35-3040, MBCD-35-4050 TRIAGE MEDICAL INC BRAD CULBERT
K014304 03/27/2002 BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S TRIAGE MEDICAL INC BRAD CULBERT
K013677 03/08/2002 MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM U.S. FILTER/IONPURE, INC. DAVID A DENTINO
K020500 03/19/2002 UNIVEC BIFURCATED SLIDING SHEATH SYRINGE UNIVEC, INC. R. COHEN
K014248 03/21/2002 DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER UROGYN LTD. EREZ ADIV
K014127 03/15/2002 KARMA DISCOVERY, MODEL KP40 VESTIL MANUFACTURING CORP. RICH MICHAEL
K020658 03/07/2002 VIATRONIX V3D COLON VIATRONIX, INC. BAMAN PATTANAYAK
K014154 03/18/2002 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
K014111 03/06/2002 REBILDA SC VOCO GMBH EVAN DICK
K020190 03/13/2002 PORTADUR P 4 WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
K020194 03/15/2002 SIMIDUR KF PLUS WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
K020195 03/15/2002 SIMIDUR S1S WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
K020192 03/15/2002 SIMIDUR S2 WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
K020180 03/21/2002 RELIEFBAND DEVICE, MODELS RB-DL, RB-EL, RB-RL WOODSIDE BIOMEDICAL, INC. CAROL PATTERSON
K020336 03/14/2002 ENDOSCOPIC CAMERA MC404/C3 WORLD OF MEDICINE LEMKE GMBH SUSANNE RAAB
K014158 03/14/2002 ENDOSCOPIC CAMERA TC804/C4 WORLD OF MEDICINE LEMKE GMBH SUSANNE RAAB
K014171 03/15/2002 ADVANCE UNICONDYLAR KNEE SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
K013473 03/06/2002 XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL XTRAK MEDICAL INC. DEBBIE IAMPIETRO
K012755 03/15/2002 AUTODIMER ASSAY MODEL # 1431 XTRANA, INC. PATRICK J O'LEARY
K011388 03/25/2002 ZOLL PAD ZOLL MEDICAL CORP. PAUL DIAS


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