| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K022547 |
08/28/2002 |
ACIDIFIED TYRODES SOLUTION |
INTL., INC. |
MICHAEL D CECCHI |
| K022330 |
08/26/2002 |
ALLGRAD 45 AND 90 CELL SEPARATION MEDIA |
INTL., INC. |
MICHAEL D CECCHI |
| K022335 |
08/23/2002 |
ALLGRAD AND ALLGRAD100 |
INTL., INC. |
MICHAEL D CECCHI |
| K022334 |
08/28/2002 |
HTF PLUS - HTF WITH NON-ESSENTIAL AMINO ACIDS |
INTL., INC. |
MICHAEL D CECCHI |
| K022352 |
08/28/2002 |
HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS) |
INTL., INC. |
MICHAEL D CECCHI |
| K022332 |
08/23/2002 |
LITE MINERAL OIL |
INTL., INC. |
MICHAEL D CECCHI |
| K022590 |
08/30/2002 |
PVP (POLYVINYLPYRROLIDONE) |
INTL., INC. |
MICHAEL D CECCHI |
| K022476 |
08/02/2002 |
RELYX RMGIP |
3M COMPANY |
KAREN O'MALLEY |
| K021450 |
08/01/2002 |
CLINPRO PROPHY POWDER |
3M ESPE AG DENTAL PRODUCTS |
ANDREAS PETERMANN |
| K020768 |
08/23/2002 |
3T VESSEL CANNULAS |
3T MEDICAL SYSTEMS, LLC. |
ROBERT P EATON |
| K020529 |
08/26/2002 |
LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2 |
A-MED SYSTEMS, INC. |
CYNTHIA G ROYSTER |
| K021782 |
08/26/2002 |
BNF |
AAP IMPLANTATE AG |
DIPL-ING CHRISTIAN ABEL |
| K022203 |
08/01/2002 |
ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384 |
ABBOTT LABORATORIES |
FRANK POKROP |
| K021960 |
08/16/2002 |
PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY |
ABBOTT LABORATORIES |
JANET S CONNOLLY |
| K021062 |
08/23/2002 |
CHITO-SEAL |
ABBOTT VASCULAR INC. |
SEVRINA CIUCCI |
| K020984 |
08/14/2002 |
ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS |
ACCESS CARDIOSYSTEMS, INC. |
DAVID BARASH |
| K022480 |
08/22/2002 |
ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC |
ACMI CORPORATION |
JOHN A DELUCIA |
| K022567 |
08/13/2002 |
SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM |
ACUSON CORP. |
JERRY W TSUTSUMI |
| K012693 |
08/01/2002 |
MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES |
ACUTRONIC MEDICAL SYSTEMS AG |
TERRY TORZALA |
| K022428 |
08/06/2002 |
QUANTITATIVE BLOOD POOL SPECT (QBS) |
ADAC LABORATORIES |
COLEEN COLEMAN |
| K021964 |
08/12/2002 |
ALPHA INFUSION PUMP AND CATHETERS |
ADVANCED INFUSION, INC. |
JAMES CHRISTENSEN |
| K022222 |
08/08/2002 |
LAMITRODE S-SERIES (S4 AND S8) LEADS |
ADVANCED NEUROMODULATION SYSTEM,INC |
KATRYNA WARREN |
| K013003 |
08/28/2002 |
APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER |
ADVANCED STERILIZATION PRODUCTS |
NATALIE BENNINGTON |
| K021528 |
08/21/2002 |
REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP |
ADVEN MEDICAL |
MARK W ALDANA |
| K022511 |
08/26/2002 |
AART CALF IMPLANT |
AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. |
CATHERINE RIPLE |
| K022223 |
08/08/2002 |
AART SILICONE SHEETING |
AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. |
CATHERINE RIPLE |
| K021542 |
08/06/2002 |
ADC DENTAL |
AGFA CORP. |
JEFF JEDLICKA |
| K021934 |
08/12/2002 |
MODIFICATION TO MEDSTATION |
AISOFTW@RE MEDICAL, S.P.A. |
DIANA UPTON |
| K022209 |
08/06/2002 |
ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS |
ALARIS MEDICAL SYSTEMS, INC. |
RENNE L FLUET |
| K021143 |
08/08/2002 |
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION |
ALCON UNIVERSAL, LTD. |
RALPH H LARSEN |
| K022564 |
08/30/2002 |
INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K021386 |
08/05/2002 |
POLY STAT HCG DIPSTICK TEST |
ALIDEX, INC. |
HELEN LANDICHO |
| K012931 |
08/20/2002 |
GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM |
ALLEGIANCE HEALTHCARE CORP. |
LANCE MARCONI |
| K012708 |
08/13/2002 |
ELECTROPHYSIOLOGY CATHETER |
ALLIANCE MEDICAL CORP. |
DON SELVEY |
| K013396 |
08/07/2002 |
ALPHA DRIVE SYSTEM |
ALPHA OMEGA LTD. |
AJWAD AKASHI |
| K022425 |
08/14/2002 |
SCREWLINE |
ALTATEC BIOTECHNOLOGIES N.A., INC. |
ROBERT J SLOMOFF |
| K021493 |
08/30/2002 |
ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S & 18S |
ANDERSEN PRODUCTS, INC. |
WENDY HEDRICK |
| K014023 |
08/02/2002 |
BABY TEETHER, MODEL 20104 |
ANGELINA TRADING, INC. |
JOHN CHANG |
| K013756 |
08/29/2002 |
ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES) |
ARGUS BIOMEDICAL PTY LTD |
BARBARA S FANT |
| K021723 |
08/08/2002 |
SHEATH ADAPTER, MODEL SA-09847 |
ARROW INTL., INC. |
BRANDON EPTING |
| K021293 |
08/22/2002 |
ARTERIA BLOOD FILTER |
ARTERIA MEDICAL SCIENCE, INC. |
ALAN HINTON |
| K022543 |
08/30/2002 |
ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| DEN020003 |
08/20/2002 |
RETROX |
AURIC HEARING SYSTEMS, INC. |
DAVID J NAVAROLI |
| K014210 |
08/16/2002 |
PALMO THERMOREGULATION INTERFACE ACCESSORY |
AVACORE TECHNOLOGIES, INC. |
CRAIG COOMBS |
| K013532 |
08/22/2002 |
ULTRASTIM KIT |
AXELGAARD MFG. CO., LTD. |
DAN JEFFERY |
| K020785 |
08/28/2002 |
INTROCAN SAFETY IV CATHETER |
B. BRAUN MEDICAL, INC. |
AMY S KRALL |
| K022575 |
08/21/2002 |
PERFUSOR COMPACT WITH FM SYSTEM |
B. BRAUN MEDICAL, INC. |
LINDA MORGAN |
| K022019 |
08/01/2002 |
PERIFIX CATHETER CONNECTOR |
B. BRAUN MEDICAL, INC. |
AMY S KRALL |
| K022128 |
08/22/2002 |
BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS |
BAUSCH & LOMB INCORPORATED |
DEBRA L KETCHUM |
| K022523 |
08/12/2002 |
RAPID-FILL TUBESET, MODEL 90005 |
BAXA CORP. |
KARL STEINBECK |
| K022426 |
08/08/2002 |
BD PRESET BLOOD COLLECTION SYRINGE, BD A-LINE BLOOD COLLECTION SYRINGE, MODELS 365313, 365323,365316,365356,365373,36538 |
BECTON DICKINSON & CO. |
M. WENDY BOSSHARDT |
| K022172 |
08/12/2002 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM |
BECTON, DICKINSON & CO. |
MICHELLE B BANDY |
| K021954 |
08/01/2002 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CLINDAMYCIN 0.125-8.0MCG/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
| K022024 |
08/01/2002 |
NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (GREEN) |
BEST MANUFACTURING COMPANY |
DAVID C YOUNG |
| K022529 |
08/15/2002 |
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669 |
BIO-RAD |
ELIZABETH PLATT |
| K022525 |
08/15/2002 |
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509 |
BIO-RAD |
ELIZABETH PLATT |
| K022707 |
08/22/2002 |
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438; LEVEL S2E, MODEL 439 |
BIO-RAD |
ELIZABETH PLATT |
| K022795 |
08/30/2002 |
MODIFICATION TO THE MAESTRO SYSTEM |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
WINSTON GREER |
| K022790 |
08/28/2002 |
THE AUTOTAC SYSTEM TITANIUM TACK |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
WINSTON GREER |
| K013691 |
08/13/2002 |
CERALAS D DIODE LASER SYSTEM, MODEL # D50 |
BIOLITEC, INC. |
JONATHAN S KAHAN |
| K020607 |
08/30/2002 |
SLEEPFLO, MODEL 101501 |
BIOMEC, INC. |
TRACEY H WIELINSKI |
| K021877 |
08/07/2002 |
MDA D-DIMER |
BIOMERIEUX, INC. |
RON SANYAL |
| K022045 |
08/15/2002 |
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID |
BIOMERIEUX, INC. |
Nancy Weaver |
| K022586 |
08/15/2002 |
ANTERIOR STABILIZED TIBIAL BEARINGS |
BIOMET ORTHOPEDICS, INC. |
DALENE T BINKLEY |
| K022463 |
08/16/2002 |
HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH COLLARED PROXIMAL POROUS FEMORAL STEMS |
BIOMET ORTHOPEDICS, INC. |
DALENE T BINKLEY |
| K022531 |
08/26/2002 |
2MM PEDIATRIC FLEX NAIL |
BIOMET, INC. |
TRACY J BICKEL |
| K021786 |
08/26/2002 |
TITANIUM ANKLE ARTHRODESIS NAIL |
BIOMET, INC. |
LONNIE WITHAM |
| K020710 |
08/14/2002 |
BIOTEST HEMOGLOBIN MEASURING SYSTEM |
BIOTEST MEDIZINTECHNIK GMBH |
MARK LICATA |
| K021503 |
08/01/2002 |
UNINHIBITED |
BISCO, INC. |
STEPHEN (STEVE) SMITH |
| K022399 |
08/06/2002 |
BLACKSTONE SPINAL FIXATION SYSTEM SPACER |
BLACKSTONE MEDICAL, INC. |
ALAN LOMBARDO |
| K022605 |
08/21/2002 |
BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER |
BLACKSTONE MEDICAL, INC. |
ALAN LOMBARDO |
| K021996 |
08/23/2002 |
BOLTON PTA CATHETER |
Bolton Medical, Inc. |
VIVIAN KELLY |
| K022427 |
08/22/2002 |
CONTOUR SE MICROSPHERES |
BOSTON SCIENTIFIC CORP. |
JODI LYNN GREENIZEN |
| K020120 |
08/02/2002 |
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 6220 |
BOSTON SCIENTIFIC CORP. |
PAIGE SWEENEY |
| K013784 |
08/08/2002 |
URETERAL STENT |
BOSTON SCIENTIFIC CORP. |
JANET A MCGRATH |
| K021735 |
08/08/2002 |
BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC SCIMED, INC. |
CANDICE BURNS |
| K020833 |
08/08/2002 |
BOYD DELIVERY UNIT |
BOYD INDUSTRIES, INC. |
BRUCE LIVINGSTON |
| K020312 |
08/07/2002 |
ULTIMA SNORING MIKE, MODEL 0540 |
BRAEBON MEDICAL CORP. |
RICHARD A BONATO |
| K021583 |
08/12/2002 |
PATXFER |
BRAINLAB AG |
STEFAN VILSMEIER |
| K021355 |
08/30/2002 |
ENDOSSEOUS IMPLANT |
BRANEMARK INTEGRATION AB |
RICKARD BRANEMARK |
| K021481 |
08/06/2002 |
BRESAGEN CATHETER, MODEL CS-3000 |
BRESAGEN, INC. |
JOHN KUCHARCZYK |
| K022509 |
08/13/2002 |
BRUNO ELECTRA-RIDE, MODEL SRE-2700 |
BRUNO INDEPENDENT LIVING AIDS, INC. |
RICHARD KELLER |
| K022350 |
08/23/2002 |
BARD CRURASOFT PATCH, MODELS 0116003 & 0116001 |
C.R. BARD, INC. |
BRIAN A KANERVIKO |
| K022434 |
08/05/2002 |
BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U |
C.R. BARD, INC. |
BETH A ZIS |
| K022561 |
08/23/2002 |
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 |
C.R. BARD, INC. |
PEGGY KEIFFER |
| K022054 |
08/06/2002 |
F 900 |
C.S.O. S.R.L. |
R. BRENT MINER |
| K021617 |
08/02/2002 |
C.T.M. POWER CHAIR, MODEL HS-2800 |
C.T.M. HOMECARE PRODUCT, INC. |
ROBERT S MCQUATE |
| K020057 |
08/27/2002 |
PALMLIGHT |
CAO GROUP, INC. |
TRACY S BEST |
| K020150 |
08/02/2002 |
CRC-15BT |
CAPINTEC, INC. |
MARY ANNE DELL |
| K021574 |
08/12/2002 |
TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
| K021080 |
08/29/2002 |
NONCOR INFUSION SETS; NONCOR PORT INFUSION SETS |
CARDIOMED SUPPLIES, INC. |
DONNA MCCOMB |
| K022107 |
08/08/2002 |
CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 |
CARDIOMEDICS, INC. |
GARY CLARK |
| K013305 |
08/23/2002 |
ENOXAPARIN TEST CARD |
CARDIOVASCULAR DIAGNOSTICS, INC. |
PETER SCOTT |
| K021781 |
08/30/2002 |
EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS |
CHAY MEDICAL, LLC. |
STEPHEN C PEARSON |
| K022232 |
08/01/2002 |
CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3 |
CLINIQA CORPORATION |
CAROL RUGGIERO |
| K022491 |
08/27/2002 |
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS |
CLINIQA CORPORATION |
CAROL RUGGIERO |
| K021737 |
08/26/2002 |
REPHRESH VAGINAL GEL |
COLUMBIA LABORATORIES, INC. |
SUSAN A WITHAM |
| K022044 |
08/23/2002 |
SURGISIS STAPLE LINE REINFORCEMENT |
COOK BIOTECH, INC. |
MARK BLEYER |
| K022002 |
08/12/2002 |
SYDNEY IVF CULTURE OIL |
COOK UROLOGICAL, INC. |
BRENDA DAVIS |
| K021920 |
08/14/2002 |
7.0 FR. ENDOBRONCHIAL BLOCKER |
COOK, INC. |
APRIL LAVENDER |
| K021898 |
08/14/2002 |
SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM |
CORDIS CORP. |
SAM MIRZA |
| K022435 |
08/14/2002 |
507EL VITAL SIGNS MONITOR |
CRITICARE SYSTEMS, INC. |
ALEX KAPLAN |
| K021633 |
08/14/2002 |
ECAT VISION PET SCANNER, MODELS 3000 & 5000 |
CTI PET SYSTEMS, INC. |
WILLIAM SKREMSKY |
| K013623 |
08/16/2002 |
CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420 |
CURELIGHT LTD |
JONATHAN S KAHAN |
| K022290 |
08/27/2002 |
PROTEIN S AC |
DADE BEHRING, INC. |
DONNA A WOLF |
| K020550 |
08/28/2002 |
PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX |
DATASCOPE CORP. |
RUSSELL OLSEN |
| K021265 |
08/30/2002 |
DATEX-OHMEDA HMEF 500 |
DATEX-OHMEDA |
JOEL C KENT |
| K022507 |
08/23/2002 |
DATEX-OHMEDA S/5 NETWORK AND CENTRAL '02 |
DATEX-OHMEDA |
JOEL KENT |
| K021352 |
08/01/2002 |
DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMODIALYSIS |
DAYTON WATER SYSTEMS |
DAYNE GILLELAND |
| K022704 |
08/27/2002 |
TAILWIND |
DELTAGLIDE |
JERE PERCHY |
| K020655 |
08/13/2002 |
DELTEC INSULIN INFUSION PUMP AND ACCESSORIES |
DELTEC, INC. |
LISA STONE |
| K021999 |
08/13/2002 |
GRIPPER PLUS NEEDLE |
DELTEC, INC. |
LISA STONE |
| K021805 |
08/19/2002 |
SEAL & PROTECT PROTECTIVE SEALANT |
DENTSPLY INTL. |
P. JEFFERY LEHN |
| K022623 |
08/27/2002 |
5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM) |
DEPUY ACROMED |
FRANK MAAS |
| K022285 |
08/13/2002 |
MODIFICATION TO ISOLA SPINAL SYSTEM |
DEPUY ACROMED |
LISA GILMAN |
| K022246 |
08/02/2002 |
MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM |
DEPUY ACROMED |
KAREN F JURCZAK |
| K021933 |
08/26/2002 |
TEMPFIX EXTERNAL FIXATION SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
CHERYL K HASTINGS |
| K022538 |
08/23/2002 |
IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
MIKE BERG |
| K022603 |
08/21/2002 |
IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K022153 |
08/15/2002 |
BLADDERSCAN BVI 6100 |
DIAGNOSTIC ULTRASOUND CORP. |
RUSS GARRISON |
| K022184 |
08/20/2002 |
FLASH-LITE LED DENTAL CURING LIGHT |
DISCUS DENTAL, INC. |
GARRY L HOLLAR |
| K021725 |
08/02/2002 |
DISETRONIC D-TRON INSULIN INFUSION PUMP |
DISETRONIC MEDICAL SYSTEMS AG |
SANDRA SONIEC |
| K021724 |
08/19/2002 |
DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEMS |
DORNIER MEDTECH AMERICA, INC. |
Tim Thomas |
| K022544 |
08/21/2002 |
DORNIER MEDILAS H LASER FIBER CABLES |
DORNIER MEDTECH AMERICA, INC. |
Tim Thomas |
| K022031 |
08/29/2002 |
NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2 |
DRAEGER MEDICAL, INC. |
MICHAEL A KELHART |
| K021753 |
08/06/2002 |
E-CARE INFARED EAR THERMOMETER, MODEL LCT-200 |
E-CARE TECHNOLOGY CORPORATION |
SUSAN D GOLDSTEIN-FALK |
| K021749 |
08/12/2002 |
EBI DYNAFIX VS OSTEOTOMY SYSTEM |
EBI, L.P. |
JON CAPARETTA |
| K022419 |
08/12/2002 |
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM |
EBI, L.P. |
JON CAPAROTTA |
| K022319 |
08/12/2002 |
EBI XFIX DFS SYSTEM |
EBI, L.P. |
FREDERIC TESTA |
| K022328 |
08/13/2002 |
EMS PIEZON MASTER 600 |
ELECTRO MEDICAL SYSTEMS SA |
CYNTHIA J.M. NOLTE |
| K021550 |
08/09/2002 |
LUMENIS SELECTA DUET |
Ellex Medical Pty. Ltd. |
BILL SWAIM |
| K022437 |
08/23/2002 |
UNI KNEE |
ENCORE MEDICAL, L.P. |
JOANNA DROEGE |
| K022578 |
08/23/2002 |
ENDIUS FLEXTIP BLADE |
ENDIUS, INC. |
CHRISTINE KUNTZ-NASSIF |
| K021837 |
08/30/2002 |
BRANENMARK BONE-ANCHORED-HEARING AID (BAHA) |
ENTIFIC MEDICAL SYSTEMS, INC. |
CONSTANCE BUNDY |
| K021765 |
08/16/2002 |
CEMENT RESTRICTOR, SMALL AND LARGE |
EXACTECH, INC. |
GARY MILLER |
| K021599 |
08/13/2002 |
96 CHANNEL EEG HEADBOX MODEL EMU96 |
EXCEL TECH. LTD. |
JOHN MUNFORD |
| K021486 |
08/01/2002 |
HERPESELECT 2 ELISA IGG, MODEL ELO920G |
FOCUS TECHNOLOGIES, INC. |
MICHAEL J WAGNER |
| K022063 |
08/29/2002 |
SAFEPRO SAFETY SYRINGE |
FORMOSA MEDICAL DEVICES, INC. |
JOSEPH J CHANG |
| K022510 |
08/27/2002 |
FONIX, MODEL 7000 |
FRYE ELECTRONICS, INC. |
KRISTINA FRYE |
| K010805 |
08/06/2002 |
PRISMA SYSTEM |
GAMBRO RENAL PRODUCTS |
SUZANNE DENNIS |
| K022397 |
08/22/2002 |
SIGNA 3.0T MAGNETIC RESONANCE SYSTEM |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K022193 |
08/01/2002 |
DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MELISSA ROBINSON |
| K022482 |
08/13/2002 |
SENSA-CUFF, MODELS INFANT, CHILD, ADULT |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MELISSA ROBINSON |
| K022310 |
08/01/2002 |
ADVANTAGE WINDOWS X-RAY/MR FUSION |
GE MEDICAL SYSTEMS, INC. |
LARRY KROGER |
| K022240 |
08/06/2002 |
MOBILE MILLENNIUM MG SYSTEM |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
| K020290 |
08/14/2002 |
DASH 3000/4000 PATIENT MONITOR |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
KAREN WEBB |
| K022410 |
08/20/2002 |
SAPH-LOOP LIGATING LOOP |
GENZYME BIOSURGERY |
KAREN K SYLVIA |
| K022362 |
08/09/2002 |
GIVEN DIAGNOSTICS SYSTEM |
GIVEN IMAGING LTD. |
SHOSHANA FRIEDMAN |
| K013828 |
08/13/2002 |
GLOVCO EBONY |
GLOVCO (M) SDN. BHD. |
TAN PENG HOCK |
| K021807 |
08/29/2002 |
GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM |
GRASS INSTRUMENT CO. |
PETER L FULLER |
| K021455 |
08/02/2002 |
RAPIDO GUIDING CATHETER, 6F MODEL# 6776; RAPIDO GUIDING CATHETER, 8F MODEL# 6775, 6777, 6778, 6779, 6780, 6781, 6782, |
GUIDANT CORP. |
KAREN S ALSOP |
| K022718 |
08/28/2002 |
VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002 |
GUIDANT CORPORATION, CARDIAC SURGERY |
ANNE SCHLAGENHAFT |
| K021777 |
08/26/2002 |
GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) |
GYRUS ENT L.L.C. |
JEFFREY W COBB |
| K020759 |
08/13/2002 |
7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT |
HANS RUDOLPH, INC. |
KEVIN RUDOLPH |
| K021916 |
08/29/2002 |
HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001 |
HARMAC MEDICAL PRODUCTS, INC. |
ROBERT F MORAN |
| K022333 |
08/15/2002 |
SPIFE LIPPOROTEIN-12, MODEL 3344 |
HELENA LABORATORIES |
PATRICIA FRANKS |
| K020226 |
08/22/2002 |
XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03 |
HELLEN PROFESSIONAL SERVICES |
ROBIN HELLEN |
| K022305 |
08/08/2002 |
MULTIPLE LABELS, POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE |
HEYUAN HONGLI INDUSTRIES, INC. |
JANNA P TUCKER |
| K021751 |
08/15/2002 |
ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUGLAS THISTLETHWAITE |
| K021472 |
08/06/2002 |
HMS-DHR-3 NEUROMUSCULAR STIMULATOR |
HOME MEDICAL SERVICES |
C.A. TEKLINSKI |
| K021496 |
08/06/2002 |
HMS-DHR-3 NEUROMUSCULAR STIMULATOR |
HOME MEDICAL SERVICES |
C.A. TEKLINSKI |
| K022546 |
08/12/2002 |
HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES |
HORIZONS INTL. CORP. |
RAFIC SALEH |
| K022461 |
08/22/2002 |
S2 FEMORAL NAIL |
HOWMEDICA OSTEONICS |
KAREN ARIEMMA |
| K022160 |
08/01/2002 |
XIA SPINAL SYSTEM |
HOWMEDICA OSTEONICS |
KAREN ARIEMMA |
| K022555 |
08/26/2002 |
ACCOLADE C FEMORAL STEMS |
HOWMEDICA OSTEONICS CORP. |
DEBRA BING |
| K022481 |
08/26/2002 |
S2 TIBIAL NAIL |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K021949 |
08/12/2002 |
FULCRUM |
HOWTEK, INC. |
JOHN E ROSENSTENGEL |
| K022530 |
08/26/2002 |
POWDERED LATEX EXAM GLOVES WITH PROTEIN LABELING (200UG/G OR LESS) |
HYCARE INTL. CO., LTD. |
JANNA P TUCKER |
| K022074 |
08/13/2002 |
SPHERZ |
I.Z.I. CORP. |
HELEN ZINREICH |
| K022563 |
08/30/2002 |
HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1 |
IMPLEX CORP. |
MARCI HALEVI |
| K022233 |
08/12/2002 |
HYDROBOOT |
INCAPPE, INC. |
ROBERT SHERIDAN |
| K013958 |
08/19/2002 |
INDUS TEXTILES TOWEL-STERILE AND NON-STERILE |
INDUS TEXTILES, INC. |
MICHELE H VOVOLKA |
| K021668 |
08/12/2002 |
NITRILE EXAMINATION GLOVES POWDERFREE (BLUE COLOR) |
INNOVATIVE GLOVES CO; LTD |
RAJEEV KUMAR SOOD |
| K022032 |
08/29/2002 |
ACETAL |
INOVATIV, LLC |
ROBERT BOWERS |
| K022030 |
08/28/2002 |
POLY-CARB |
INOVATIV, LLC |
ROBERT BOWERS |
| K022195 |
08/07/2002 |
COAMATIC AT-400 |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K022550 |
08/27/2002 |
COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K021792 |
08/14/2002 |
BILAYER MATRIX WOUND DRESSING |
INTEGRA LIFESCIENCES CORP. |
DIANA M BORDON |
| K022553 |
08/20/2002 |
CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L |
INTEGRA NEUROSCIENCES |
NANCY A MATHEWSON |
| K022554 |
08/23/2002 |
MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM |
INTEGRA NEUROSCIENCES |
DONNA WALLACE |
| K022348 |
08/15/2002 |
ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000 |
INTERPORE CROSS INTL. |
PROSIE REY-FESSLER |
| K022242 |
08/14/2002 |
INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER |
INTERVASCULAR |
Amy Aulwes |
| K022260 |
08/29/2002 |
FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS |
ISOLATION SYSTEMS, INC. |
TED ULATOWSKI |
| K013869 |
08/28/2002 |
SR IVOCRON |
IVOCLAR VIVADENT, INC. |
DONNA M HARTNETT |
| K022206 |
08/29/2002 |
JENSEN GOLD FOIL |
JENSEN INDUSTRIES, INC. |
JOHN SLANSKI |
| K022486 |
08/14/2002 |
K-ASSAY HS-CRP CONTROLS |
KAMIYA BIOMEDICAL CO. |
BRIAN SCHLIESMAN |
| K021776 |
08/15/2002 |
KSEA QUADRO SWITCH |
KARL STORZ ENDOSCOPY |
JAMES A LEE |
| K011700 |
08/16/2002 |
MODULITH SLK LITHOTRIPTER |
KARL STORZ ENDOSCOPY |
JENNIFER S PORTUGAL |
| K022102 |
08/22/2002 |
CLEANTEXX POWDERFREE BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVES, BLUE COLOUR |
LATEXX MANUFACTURING SDN.BHD. |
LAW SIAU WOEI |
| K022548 |
08/15/2002 |
MEDTEXX BLUE COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES |
LATEXX MANUFACTURING SDN.BHD. |
LAW SIAU WOEI |
| K022347 |
08/15/2002 |
MEDTEXX GREEN COLOUR POWDERED NITRILE RUBBER EXAMINATION GLOVES |
LATEXX MANUFACTURING SDN.BHD. |
TEOH CHOH SHEE |
| K022101 |
08/02/2002 |
MEDTEXX POWDERFREE NITRILE RUBBER EXAMINATION GLOVES, GREEN COLOUR |
LATEXX MANUFACTURING SDN.BHD. |
LAW SIAU WOEI |
| K013197 |
08/29/2002 |
WS-501 HEAT LAMP |
LHASA MEDICAL, INC. |
KYUNG P RIIHIMAKI |
| K021819 |
08/23/2002 |
ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM |
LIFESCAN, INC. |
MARY ELLEN HOLDEN |
| K021538 |
08/08/2002 |
LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR |
LIGHTMED CORP. |
IRENE LIN |
| K021887 |
08/15/2002 |
CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071 |
Lin-Zhi International, Inc. |
CHIU CHIN CHANG |
| K013999 |
08/06/2002 |
LODOX, MODEL BASELINE |
LODOX SYSTEMS (PTY) LTD. |
BRADLEY SACKS |
| K021398 |
08/27/2002 |
APL IGA ELISA KIT |
LOUISVILLE APL DIAGNOSTICS, INC. |
SILVIA S PIERANGELI |
| K021947 |
08/26/2002 |
CERANUM 87 |
LUCIUS METALS COM. |
DAE-KYU CHANG |
| K021083 |
08/30/2002 |
VERACAM |
LUMALITE, INC. |
W. EDWARD JOHANSEN |
| K021762 |
08/23/2002 |
BCLEAR |
LUMENIS, INC. |
C. ROBERT PAYNE, JR. |
| K021904 |
08/14/2002 |
MAEDA SILVER ACUPUNCTURE NEEDLE |
MAEDA TOYOKICHI SHOTEN |
E.J. Smith |
| K021579 |
08/09/2002 |
MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM |
MAGLY ORTHOPEDICS, LLC |
DAVE STINSON |
| K021662 |
08/12/2002 |
MAGLY 6.5MM CANNULATED SCREWS |
MAGLY ORTHOPEDICS, LLC |
DAVE STINSON |
| K021452 |
08/01/2002 |
STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL EXAMINATION GLOVE |
MAXXIM MEDICAL |
JULIO GONZALEZ |
| K022689 |
08/23/2002 |
MODIFICATION TO MEDAMICUS AXIA RSN |
MEDAMICUS, INC. |
KARYL HASKELL |
| K021759 |
08/27/2002 |
14F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT55 |
MEDCOMP |
FLORENCE A CAIKOSKI |
| K022395 |
08/13/2002 |
1.5T SCANMED PV ARRAY |
MEDIC, INC. |
RANDALL W JONES |
| K022568 |
08/29/2002 |
PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF UNWANTED HAIR |
MEDICAL BIO CARE SWEDEN AB |
CONNIE WHITE HOY |
| K022569 |
08/29/2002 |
PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF VASCULAR LESIONS |
MEDICAL BIO CARE SWEDEN AB |
CONNIE WHITE HOY |
| K013704 |
08/05/2002 |
MEDIPLUS SINGLE USE GI MANOMETRY CATHETER |
MEDIPLUS LTD. |
ELIZABETH M PAUL |
| K021988 |
08/29/2002 |
MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM |
MEDRAD, INC. |
LORRAINE R FREDES |
| K021791 |
08/26/2002 |
VERTE-STACK SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K022191 |
08/28/2002 |
MODIFICATION TO TENOR SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
| K022414 |
08/14/2002 |
STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE |
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES |
VICTORIA G RENDON |
| K022764 |
08/28/2002 |
7F LAUNCHER GUIDE CATHETER |
MEDTRONIC VASCULAR |
FRED L BOUCHER |
| K021902 |
08/12/2002 |
MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300 |
MEDTRONIC VASCULAR |
LUCY TAN |
| K021804 |
08/28/2002 |
PRECISION PLUS TUNA OFFICE SYSTEM; PRESISION TUNA OFFICE SYSTEM; PROVU TUNA SYSTEM |
MEDTRONIC VASCULAR |
JULIE GOODE |
| K022168 |
08/01/2002 |
ENVOY |
MENNEN MEDICAL LTD. |
DAVID P JOHNSON |
| K020400 |
08/23/2002 |
DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR |
MEPS, LLC. |
HARRY BENEDICT |
| K020360 |
08/29/2002 |
ABR-2000 |
MERIDIAN CO., LTD. |
SOO-RANG LEE |
| K020520 |
08/06/2002 |
EASYTEM EAR THERMOMETER, MODEL BT-020 |
METATECH CO., LTD. |
GUENTER GINSBERG |
| K021956 |
08/13/2002 |
MHS MED LIGHT 1000 |
MICRO HEALTH SYSTEMS INC. |
ROBERT BARNES |
| K022025 |
08/15/2002 |
MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT |
MILTON HODOSH, M.D. |
MILTON HODOSH |
| K021974 |
08/06/2002 |
MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311 |
MINIMED, INC. |
GERDA RESCH |
| K021834 |
08/28/2002 |
SUTURE FIXATION DEVICE; MESH FIXATION DEVICE |
MLE, INC. |
CHRISTINE E NICHOLS |
| K001755 |
08/05/2002 |
MPW HEMODIALYSIS WATER PURIFICATION SYSTEM |
MPW INDUSTRIAL WATER SERVICES, INC. |
BILL WATSON |
| K022372 |
08/13/2002 |
HRH-127-8 HEAD ARRAY COIL |
MRI DEVICES CORP. |
TOM SCHUBERT |
| K021631 |
08/13/2002 |
ISA-21 INTERVENTIONAL SPINE ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K022487 |
08/23/2002 |
MODEL EXS-63-INT SMALL EXTREMITY ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K022488 |
08/23/2002 |
MODEL OBC-63 BREAST ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K013051 |
08/22/2002 |
NANMA ADJUSTABLE CONSTRICTION RING |
NANMA MFG CO., LTD. |
YOLANDA SMITH |
| K021971 |
08/01/2002 |
CERALOY |
NEIRYNCK & VOGT NV |
JOSH ANDRACHEK |
| K020357 |
08/07/2002 |
800 SERIES EASYNEB NEBULIZER |
NELLCOR PURITAN BENNETT, INC. |
GINA TO |
| K021626 |
08/12/2002 |
HALLU PLATES |
NEWDEAL S.A. |
NORMAN F ESTRIN |
| K021986 |
08/23/2002 |
BRAINET |
NICOLET BIOMEDICAL, INC. |
Gary Syring |
| K022443 |
08/28/2002 |
SPERMASSIST |
NIDACON INTERNATIONAL AB |
DANIEL KAMM |
| K010727 |
08/09/2002 |
FLEXLINE CLAMP |
NOVARE SURGICAL SYSTEMS, INC. |
DAVID W SCHLERF |
| K022157 |
08/28/2002 |
RF TENT |
ODIN MEDICAL TECHNOLOGIES LTD. |
ADI ICKOWICZ |
| K022270 |
08/14/2002 |
MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA |
OLYMPUS OPTICAL CO., LTD. |
LAURA STORMS-TYLER |
| K013759 |
08/20/2002 |
MSS-28CS-301/701 NEEDLESCOPE |
OLYMPUS OPTICAL CO., LTD. |
LAURA STORMS-TYLER |
| K021696 |
08/20/2002 |
20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25 |
OPHTHALMED LLC |
JAY MANSOUR |
| K021508 |
08/07/2002 |
OPUSDUO EC DENTAL LASER SYSTEM |
OPUSDENT LTD. |
DORIT WINITZ |
| K021702 |
08/06/2002 |
CRYOBAG, MODEL CB |
ORIGEN BIOMEDICAL, INC. |
RICHARD MARTIN |
| K022711 |
08/26/2002 |
MODIFICATION TO AVALON CUP SYSTEM |
ORTHOPEDIC SOURCE INC. |
STEVEN M MANDELL |
| K021760 |
08/27/2002 |
NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120 |
ORTHOSOFT, INC. |
CHRISTOPHER MCLEAN |
| K011879 |
08/27/2002 |
3A DENTAL IMPLANT SYSTEM |
OSSECO BIOSOURCE, LTD |
MICHELE H VOVOLKA |
| K013618 |
08/14/2002 |
INTRAORAL MANDIBULAR DISTRACTION SYSTEM |
OSTEOMED CORP. |
DAWN T HOLDEMAN |
| K021618 |
08/08/2002 |
OSA RIGID INTERNAL FIXATION SYSTEM |
OSTEOMED CORP. |
DAWN T HOLDEMAN |
| K021342 |
08/01/2002 |
NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR |
OSTEOMEDICS, INC. |
ALBERT ENAYATI |
| K021341 |
08/01/2002 |
NORMED BONE TRANSPORT DISTRACTION DEVICE |
OSTEOMEDICS, INC. |
ALBERT ENAYATI |
| K021659 |
08/12/2002 |
PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS) |
P.T. HEALTHCARE GLOVINDO |
ELLEN HUTAPEA |
| K013093 |
08/01/2002 |
PALL ULTIPOR ANESTHESIA BREATHING SYSTEM |
PALL MEDICAL |
LEONARD S BERMAN |
| K022404 |
08/08/2002 |
ACTIBAND |
PAW, LLC |
ANDREW J WHELAN |
| K022150 |
08/21/2002 |
TRIONOMER |
PENTRON CLINICAL TECHNOLOGIES |
ANNMARIE TENERO |
| K021457 |
08/01/2002 |
FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL |
PENTRON CORP. |
ANNMARIE TENERO |
| K021492 |
08/07/2002 |
K-Y BRAND WARMING LIQUID PERSONAL LUBRICANT |
PERSONAL PRODUCTS CO., DIV. OF MCNEIL PPC, INC. |
MARYLOU PANICO |
| K022601 |
08/26/2002 |
POWDER-FREE LATEX EXAMINATION GLOVE (SURFACE TREATED WITH ALOE VERA GEL) |
PERUSAHAAN GETAH ASAS SDN BHD |
JAMES F LOGAN |
| K022542 |
08/20/2002 |
PHILIPS BABY THERMOMETER SET (SBC SC530) |
PHILIPS CONSUMER ELECTRONICS |
BOB POOLER |
| K021644 |
08/06/2002 |
PERF (OMMAYA STYLE) RESERVOIRS |
PHOENIX BIOMEDICAL CORP. |
COURTNEY SMITH |
| K022401 |
08/21/2002 |
PTS PANELS MULTI-CHEMISTRY CONTROLS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
| K013038 |
08/14/2002 |
SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010 |
POLYSTAN A/S |
DANA OLSEN |
| K022281 |
08/06/2002 |
SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045 |
POLYSTAN A/S |
DANA OLSEN |
| K021357 |
08/05/2002 |
MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT |
POREX SURGICAL, INC. |
HOWARD MERCER |
| K022239 |
08/23/2002 |
SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM |
PRAXIM |
SHEILA HEMEON-HEYER |
| K022072 |
08/23/2002 |
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS |
PRECISION SYSTEMS, INC. |
BILL HADEN |
| K020040 |
08/01/2002 |
LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM |
PT. MAJA AGUNG LATEXINDO |
EMMY TJOENG |
| K021573 |
08/13/2002 |
PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION |
PURITAN-BENNETT |
GINA TO |
| K021972 |
08/21/2002 |
FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY |
Qualigen, Inc. |
DOROTHY DEINZER |
| K021650 |
08/16/2002 |
ATHOSCAN FOR THE ATHOS LASER CONSTANS COOLING HAND PIECE FOR THE ATHOS LASER |
QUANTEL MEDICAL |
ROGER W BARNES |
| K022591 |
08/30/2002 |
RANDOX LIPID CONTROL |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
| K022407 |
08/16/2002 |
MULTI FUCTIONAL REHABILITATION CHAIR |
RAYE'S, INC. |
WILLARD LEE FRICKEY |
| K022405 |
08/12/2002 |
MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MIC |
REHABILICARE, INC. |
EDWARD F VALDEZ |
| K022345 |
08/15/2002 |
AUTOPULSE RESUSCITATION SYSTEM |
REVIVANT CORP. |
SUSANNE T SMITH |
| K022017 |
08/14/2002 |
RHIGENE MESACUP-2 TEST RNP, MODEL M7741 |
RHIGENE, INC. |
YUSUKE KOBE |
| K020672 |
08/05/2002 |
ELECSYS ANTI-TG TEST SYSTEM |
ROCHE DIAGNOSTICS CORP. |
SHERRI L COENEN |
| K022654 |
08/29/2002 |
MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB |
ROCHE DIAGNOSTICS CORP. |
SHERRI L COENEN |
| K020897 |
08/06/2002 |
ROSSMAX AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODELS B150 & Q400 |
ROSSMAX INTERNATIONL LTD. |
MICHAEL YEH |
| K021540 |
08/01/2002 |
RUSCH EDGAR TUBE |
RUSCH INTL. |
RICK LYKINS |
| K021064 |
08/08/2002 |
QUANTIM 16 AUTOCLAVE |
SCICAN |
BRENDA MURPHY |
| K021707 |
08/14/2002 |
SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, SINGLE STEP HOLDERS |
SENORX, INC. |
AMY BOUCLY |
| K020597 |
08/14/2002 |
SERRALGUT |
SERRAL, S.A. DE C.V. |
SCOTT HENDERSON |
| K021853 |
08/01/2002 |
DISPOSABLE VINYL EXAMINATION GLOVES, YELLOW COLOR, POWDER FREE WITH VITAMIN E |
SHANGHAI ANTARES INDUSTRIES, INC. |
JOHN LAI |
| K022337 |
08/13/2002 |
3D NAVIGATION INTERFACE FOR SIREMOBILE ISO-C 3D |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
AMY SHAW HOSLER |
| K021162 |
08/30/2002 |
AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT II |
| K022065 |
08/06/2002 |
SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X |
SINTEA BIOTECH, INC. |
MARIANNE GRUNWALDT |
| K022556 |
08/28/2002 |
REFLECTION MODIFIED ACETABULAR SHELLS |
SMITH & NEPHEW, INC. |
KIM KELLY |
| K022460 |
08/19/2002 |
SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATIONS |
SMITH & NEPHEW, INC. |
GINO ROUSS |
| K022010 |
08/19/2002 |
TOTAL KNEE FEMORAL COMPONENT |
SMITH & NEPHEW, INC. |
KIM KELLY |
| K021720 |
08/12/2002 |
MULTIVISION METHAFILCON A SOFT (HYDROPILIC) MULTIFOCAL LENS FOR DAILY WEAR |
SOFLEX ISRALENS CONTACT LENS LTD. |
Kevin Walls |
| K022317 |
08/02/2002 |
DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETS |
SOOIL DEVELOPMENT CO., LTD. |
CYNTHIA J.M. NOLTE |
| K013046 |
08/21/2002 |
COSMOS SYSTEM |
SPACELABS MEDICAL, INC. |
EDWARD M BASILE |
| K021995 |
08/01/2002 |
ESCAPE CONTROL MODULE |
SPECIALTY DRIVES TECHNOLOGIES, INC. |
SCOTT KERSEY |
| K022218 |
08/12/2002 |
CADENCE CEMENT RESTRICTOR |
SPINAL CONCEPTS, INC. |
DAVID M HOOPER |
| K021719 |
08/15/2002 |
FORTITUDE CEMENT RESTRICTOR |
SPINAL CONCEPTS, INC. |
DAVID M HOOPER |
| K021507 |
08/01/2002 |
PLUS PIVOT LINK UNIVERSAL SYSTEM |
SPINE VISION, INC |
LYNNETTE WHITAKER |
| K021510 |
08/01/2002 |
UNI-T UNI-THREAD SPINAL SYSTEM |
SPINE VISION, INC |
LYNNETTE WHITAKER |
| K021549 |
08/01/2002 |
CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM |
STD MFG., INC. |
STEVE EK |
| K012523 |
08/14/2002 |
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS |
STERILMED, INC. |
PATRICK FLEISCHHACKER |
| K012678 |
08/14/2002 |
REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS |
STERILMED, INC. |
PATICK FLEISCHHACKER |
| K022248 |
08/06/2002 |
STRYKER L3 HYDROLERT |
Stryker Endoscopy |
MICHAEL HILLDOERFER |
| K021440 |
08/02/2002 |
BONESOURCE HAC |
STRYKER INSTRUMENTS |
WADE T RUTKOSKIE |
| K022162 |
08/01/2002 |
STRYKER T4 URETHANE HOOD; STRYKER T4 URETHANE ZIPPER TOGA; STRYKER T4 URETHANE PULLOVER TOGA |
STRYKER INSTRUMENTS |
DANNIELLE WHEELER |
| K020320 |
08/28/2002 |
RADIOSYSTEM/NT, MODEL 80-13020 |
STYKER INSTRUMENTS |
KELLI BITTERBURG |
| K021578 |
08/09/2002 |
NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE |
SULZER ORTHOPEDICS, INC. |
FRANCES E HARRISON |
| K021718 |
08/15/2002 |
INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY |
SUNI IMAGING MICROSYSTEMS, INC. |
F. AL BETTENCOURT |
| K021747 |
08/15/2002 |
DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR |
SURGICON, INC. |
CURTIS RAYMOND |
| K012105 |
08/02/2002 |
POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM |
SYMMETRY MEDICAL, INC. |
D. DARIN MARTIN |
| K020220 |
08/23/2002 |
ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE |
SYNERGETICS, INC. |
SUE OSTER |
| K021556 |
08/09/2002 |
SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW |
SYNTHES (USA) |
BONNIE J SMITH |
| K021642 |
08/14/2002 |
SYNTHES CRANIOFACIAL PLATES |
SYNTHES (USA) |
MATTHEW M HULL |
| K021731 |
08/08/2002 |
ADAPT OPEN ACCESS PORT, MODEL 41233 |
TAUT, INC. |
MAX CLOAT |
| K020537 |
08/15/2002 |
TL10 TENSYMETER BLOOD PRESSURE MONITORING SYSTEM |
TENSYS MEDICAL, INC. |
STUART L GALLANT |
| K014270 |
08/15/2002 |
MININEPH HUMAN B2-MICROGLOBULIN KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K022197 |
08/13/2002 |
SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY |
THE ELECTRODE STORE, INC. |
CARL YOUNGMANN |
| K003128 |
08/12/2002 |
MODIFICATION TO RELIEF BRIEF |
THE JM KOHN CO. |
CHARLES L MORIN |
| K021950 |
08/01/2002 |
TOP GLOVE MEDICAL (THAILAND) POWDERED LATEX EXAMINATION GLOVES |
TOP GLOVE MEDICAL (THAILAND) CO., LTD. |
AUDIE SEOW |
| K021855 |
08/05/2002 |
TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS) |
TOP GLOVE SDN. BHD. |
LIM WEE CHAI |
| K022400 |
08/06/2002 |
SSA-700A, APLIO DIAGNOSTIC ULTRASOUND SYSTEM |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
MICHAELA MAHL |
| K021738 |
08/19/2002 |
FLAT PANEL DISPLAYS, ME SERIES & CCL SERIES |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
| K021571 |
08/12/2002 |
TRANSONIC FLOW-QC SET MODEL ADT1010 |
TRANSONIC SYSTEMS, INC. |
MARK S ALSBERGE |
| K022354 |
08/13/2002 |
ULTRAGUIDE CTG 2000SA |
ULTRAGUIDE LTD. |
GEORGE MYERS |
| K021511 |
08/06/2002 |
CYTOFLEX MESH |
UNICARE BIOMEDICAL, INC. |
STAN YANG |
| K021657 |
08/12/2002 |
UKNEE TOTAL KNEE SYSTEM |
UNITED ORTHOPEDIC CORP. |
PHILIP LEUNG |
| K012687 |
08/01/2002 |
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS |
VANGUARD MEDICAL CONCEPTS, INC. |
MIKE SAMMON |
| K022402 |
08/22/2002 |
DISPOSABLE PRESSURE MANOMETER |
VITAL SIGNS, INC. |
DAVID L NAJJAR |
| K021315 |
08/21/2002 |
SURE-LOK |
VITAL SIGNS, INC. |
THOMAS W DIELMANN |
| K021745 |
08/20/2002 |
VASCLIP |
VMBC, LLC |
DAVID ELLIOT, JR. |
| K022066 |
08/14/2002 |
REGISTRADO X-TRA |
VOCO GMBH |
GERALD W SHIPPS |
| K021686 |
08/20/2002 |
LASER FIBER GF500 |
W.O.M. WORLD OF MEDICINE AG |
SUSANNE RAAB |
| K021808 |
08/14/2002 |
WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER |
WECK |
JAMES LUCKY |
| K022453 |
08/21/2002 |
MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM |
WELCH ALLYN PROTOCOL, INC. |
DON M ABBEY |
| K022095 |
08/09/2002 |
DURACLEAN WITH LYCRA POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE |
WILSHIRE TECHNOLOGIES |
STEVE REITZLER |
| K021717 |
08/20/2002 |
ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5 |
WORLD OF MEDICINE LEMKE GMBH |
SUSANNE RAAB |
| K021456 |
08/01/2002 |
ER150/M2 |
WORLD OF MEDICINE LEMKE GMBH |
SUSANNE RAAB |
| K011327 |
08/15/2002 |
DB1 EMBRYO FREEZE |
ZANDER MEDICAL SUPPLIES, INC. |
FRED ZANDER |
