FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K021460 |
05/22/2002 |
OCO DENTAL IMPLANT |
"O" CO., INC. |
DAVID D DALISE |
K020365 |
05/03/2002 |
3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE |
3T MEDICAL SYSTEMS, LLC. |
ROBERT P EATON |
K020618 |
05/14/2002 |
AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL |
AALTO SCIENTIFIC LTD. |
KENNETH GAUTHIER |
K020579 |
05/13/2002 |
AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR03 |
AARON MEDICAL INDUSTRIES |
RICHARD A KOZLOFF |
K020452 |
05/07/2002 |
HIGH SILVER CONVENTIONAL |
AB ARDENT |
CLYDE E INGERSOLL |
K021350 |
05/14/2002 |
ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348 |
ABBOTT LABORATORIES |
FRANK POKROP |
K011461 |
05/28/2002 |
ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR |
ACCESS CARDIOSYSTEMS, INC. |
DAVID BARASH |
K013596 |
05/16/2002 |
MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP) |
ACCUMETRICS, INC. |
RHONDA MOE |
K021244 |
05/03/2002 |
ACE HA SCREW DENTAL IMPLANT SYSTEM |
ACE SURGICAL SUPPLY CO., INC. |
J EDWARD CARCHIDI |
K021272 |
05/21/2002 |
SIB CATHETER, MODEL 61-7005 |
ACKRAD LABORATORIES |
RICHARD HETTENBACH |
K021166 |
05/09/2002 |
ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR |
ACMI-CIRCON CORPORATION |
JOHN A DELUCIA |
K020313 |
05/08/2002 |
ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE |
ACON LABORATORIES CO. |
EDWARD TUNG |
K020771 |
05/15/2002 |
ACON ONE STEP DRUG SCREEN TEST CARD |
ACON LABORATORIES, INC. |
EDWARD TUNG |
K021614 |
05/30/2002 |
DIGITAL CLINICAL THERMOMETER, MODEL ACT 3020 |
ACTHERM, INC. |
RICHARD HSIEH |
K021612 |
05/30/2002 |
DIGITAL CLINICAL THERMOMETER, MODELS ACT 2030, 2038 |
ACTHERM, INC. |
RICHARD HSIEH |
K013886 |
05/10/2002 |
AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) |
ADVANCED DIAGNOSTICS, INC. |
STEVE HESSLER |
K021175 |
05/15/2002 |
AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000 |
AEROGEN, INC. |
TRACI V. A EDWARDS |
K021447 |
05/22/2002 |
TELE-CLINIQ DATA TRANSMISSION SYSTEM BLOOD PRESSURE MEASUREMENT SYSTEM |
AEROTEL MEDICAL SYSTEMS (1998) LTD. |
GEORGE MYERS |
K020648 |
05/01/2002 |
GRIDLOCK 195 ADHESIVE |
ALLODEX SYSTEMS |
MELVYN A STEINBERG |
K021263 |
05/15/2002 |
MODIFICATION TO SPARC SLING SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
MARK MCINTYRE |
K021439 |
05/29/2002 |
MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO |
ANIMAS CORP. |
MICHAEL J ANDREWS |
K020865 |
05/08/2002 |
ONLINE POWDER FREE, LATEX EXAMINATION GLOVES |
APL PRODUCTS SDN. BHD. |
LEE SON HONG |
K020577 |
05/22/2002 |
APPLIED URETERAL CATHETER |
APPLIED MEDICAL RESOURCES CORP. |
ANIL BHALANI |
K021121 |
05/28/2002 |
AROMACRYL |
AROMACRYL, LLC |
TANYA L WOODS |
K021120 |
05/02/2002 |
RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP |
ARROW INTL., INC. |
DEBBIE PEACOCK |
K021364 |
05/30/2002 |
MODIFICATION TO ENTEC PLASMA WANDS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
K020408 |
05/02/2002 |
SYSTEM 2000 CONTROLLER, SYSTEM 5000 CONTROLLER, FOOTSWITCH, POWER CORD, AND VISAGE WANDSFF |
ARTHROCARE CORP. |
BRUCE PROTHRO |
K020634 |
05/08/2002 |
MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER |
ATRIUM MEDICAL CORP. |
JOSEPH P DE PAOLA |
K020349 |
05/02/2002 |
ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS |
AXIS-SHIELD DIAGNOSTICS, LTD. |
EILEEN A MCCAFFERTY |
K020348 |
05/02/2002 |
ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS |
AXIS-SHIELD DIAGNOSTICS, LTD. |
EILEEN A MCCAFFERTY |
K020687 |
05/02/2002 |
DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300 |
AXIS-SHIELD DIAGNOSTICS, LTD. |
EILEEN MCCAFFERTY |
K013587 |
05/14/2002 |
BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS |
BABIES BEST, INC. |
JAY SALKIN |
K020375 |
05/03/2002 |
THE NURTURE III BREAST PUMP |
BAILEY MEDICAL ENGINEERING |
BARRY BAILEY |
K020927 |
05/16/2002 |
BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS |
BAUSCH & LOMB |
DEBRA L. B KETCHUM |
K020802 |
05/31/2002 |
RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION |
BAUSCH & LOMB INCORPORATED |
PAUL G STAPLETON |
K021274 |
05/17/2002 |
PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719 |
BAXTER HEALTHCARE CORP. |
VIVKI L DREWS |
K020354 |
05/03/2002 |
BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL) |
BAYLIS MEDICAL CO., INC. |
KRIS SHAH |
K021343 |
05/20/2002 |
ISOSEEDS I-125 |
BEBIG ISOTOPEN-UND MEDIZINTECHNIK GMBH |
SVEN LANGER |
K020842 |
05/15/2002 |
ERTAPENEM 10UG BBL SENSI-DISC |
BECTON DICKINSON & CO. |
MICHELLE BANDY |
K020321 |
05/23/2002 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM |
BECTON, DICKINSON & CO. |
BRADFORD M SPRING |
K021215 |
05/15/2002 |
BIO-LOGIC ABAER CUB |
BIO-LOGIC SYSTEMS CORP. |
NORMAN E BRUNNER |
K021498 |
05/24/2002 |
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL |
BIO-RAD |
MARIA ZEBALLOS |
K021415 |
05/29/2002 |
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469 |
BIO-RAD |
ELIZABETH PLATE |
K021414 |
05/29/2002 |
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 467 |
BIO-RAD |
ELIZABETH PLATE |
K021411 |
05/29/2002 |
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463 |
BIO-RAD |
ELIZABETH PLATE |
K021384 |
05/29/2002 |
LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444 |
BIO-RAD |
ELIZABETH PLATT |
K013897 |
05/21/2002 |
SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW |
BIO-SCAN S.A |
RICHARD M SANO |
K020962 |
05/24/2002 |
G4 SLEEVED NAIL |
BIOMET MANUFACTURING, INC. |
TRACY J BICKEL |
K020381 |
05/06/2002 |
EXPANDABLE KNEE |
BIOMET ORTHOPEDICS, INC. |
PATRICIA SANDBORN BERES |
K021403 |
05/31/2002 |
HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED FEMORAL STEM |
BIOMET ORTHOPEDICS, INC. |
DALENE T BINKLEY |
K021380 |
05/28/2002 |
OSS LES PROXIMAL FEMORAL COMPONENT |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
K021182 |
05/13/2002 |
RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR |
BIOMET, INC. |
TRACY J BICKEL |
K020628 |
05/24/2002 |
CURELLE, PREFERRED CURELLE, CUTEQ 2.5 |
BIOTEQUE AMERICA, INC. |
DENIS DORSEY |
K021217 |
05/01/2002 |
AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP |
BIOTRONIK, INC. |
Jon Brumbaugh |
K013642 |
05/22/2002 |
AVEA |
BIRD PRODUCTS CORP. |
TOM GUTIERREZ |
K020730 |
05/22/2002 |
ORION NASAL CPAP SYSTEM |
BIRD PRODUCTS CORP. |
TOM GUITERREZ |
K020600 |
05/22/2002 |
BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER) |
BLACKSTONE MEDICAL, INC. |
ALAN LOMBARDO |
K020620 |
05/23/2002 |
BLACKSTONE III DEGREE ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER) |
BLACKSTONE MEDICAL, INC. |
ALAN LOMBARDO |
K020538 |
05/15/2002 |
BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES |
BOEHRINGER LABORATORIES |
CHRISTOPHER RADL |
K021232 |
05/16/2002 |
CONSTELLATION CATHETERS, MODEL 8031M |
BOSTON SCIENTIFIC CORP. |
CHRISTINA L ROWE |
K012113 |
05/03/2002 |
INDWELLING FECAL MANAGEMENT SYSTEM |
BOWEL MANAGEMENT SYSTEMS, LLC |
COLLEEN J HITTLE |
K014283 |
05/22/2002 |
LATEX SURGEONS GLOVE (POWDER FREE) |
BRIGHTWAY GLOVES PVT. LTD. |
N. PARAMASIVAN |
K014278 |
05/14/2002 |
LATEX SURGEONS GLOVE (POWDERED) |
BRIGHTWAY GLOVES PVT. LTD. |
N. PARAMASIVAN |
K020614 |
05/24/2002 |
IRRIGATING CANNULA |
CA GUARD, LTD. |
AL WEISENBORN |
K013855 |
05/09/2002 |
MICROJET CRONO H |
CANE S.R.I. |
DANIEL KAMM |
K013840 |
05/14/2002 |
MICROJET CRONO PAR AND CRONO APO-GO |
CANE SRL |
DANIEL KAMM |
K013822 |
05/08/2002 |
MICROJET CRONO PCA |
CANE SRL |
DANIEL KAMM, PE |
K012132 |
05/09/2002 |
CHROMAGEN V3.0 READING AID SOFT CONTACT LENS |
CANTOR & NISSEL LTD. |
MARTIN DALSING |
K020449 |
05/10/2002 |
CARDIONOW CARDIOLOGY WIDE AREA ARCHIVE AND RETRIEVAL SYSTEM |
CARDIONOW, INC. |
JOHNNY M GARZA |
K020637 |
05/28/2002 |
SELECT STIM |
CARE REHAB AND ORTHOPAEDIC |
CHRISTIAN HUNT |
K020516 |
05/16/2002 |
CARE IFC PLUS |
CARE REHAB, INC. |
CHRISTIAN E HUNT |
K013960 |
05/23/2002 |
APATIGHT HA-BONE GRAFT SUBSTITUTE |
CERABIO, LLC |
JAMES J CASSIDY |
K013966 |
05/16/2002 |
APATIGHT-TCP BONE GRAFT SUBSTITUTE |
CERABIO, LLC |
JAMES J CASSIDY |
K021192 |
05/16/2002 |
QACA IGG/IGM ELISA KIT HRP |
CHESHIRE DIAGNOSTICS LTD. |
NEIL B STRINGER |
K021395 |
05/13/2002 |
MODIFICATION TO 30 EXTENSION SET |
CHURCHILL MEDICAL SYSTEMS, INC. |
KEVIN PALUCH |
K021118 |
05/28/2002 |
DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570 |
CLASS A ENT. |
SAMANTHA L DRAPER |
K021054 |
05/09/2002 |
CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGER |
CODONICS, INC. |
RICK DAYTON |
K011344 |
05/17/2002 |
INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400 |
COLLINS MEDICAL, INC. |
JONATHAN S KAHAN |
K020732 |
05/30/2002 |
SS MATRIX |
COOK BIOTECH, INC. |
MARK BLEYER |
K021591 |
05/22/2002 |
PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS |
CORDIS NEUROVASCULAR, INC. |
MARITZA CELAYA |
K020723 |
05/08/2002 |
DIMENSION ALDL CALIBRATOR, MODEL DC131 |
DADE BEHRING, INC. |
RICHARD M VAUGHT |
K020724 |
05/09/2002 |
DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131 |
DADE BEHRING, INC. |
RICHARD M VAUGHT |
K020692 |
05/10/2002 |
EMIT 2000 VANCOMYCIN ASSAY |
DADE BEHRING, INC. |
DONNA A WOLF |
K020845 |
05/08/2002 |
EMIT 2000 VANCOMYCIN CALIBRATORS |
DADE BEHRING, INC. |
DONNA A WOLF |
K020820 |
05/09/2002 |
MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME |
DADE BEHRING, INC. |
CYNTHIA VAN DUKER |
K020822 |
05/08/2002 |
MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - VANCOMYCIN |
DADE BEHRING, INC. |
CYNTHIA VAN DUKER |
K020398 |
05/16/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML) |
DADE BEHRING, INC. |
MAUREEN MENDE |
K021037 |
05/06/2002 |
MICROSTREP PLUS PANEL WITH AMPICILLIN |
DADE BEHRING, INC. |
CYNTHIA VAN DUKER |
K020627 |
05/06/2002 |
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-GATIFLOXACIN |
DADE MICROSCAN, INC. |
CYNTHIA VAN DUKER |
K020937 |
05/06/2002 |
MICROSCAN MICROSTREP PLUS PANEL-AMOXICILLIN/CLAVULANIC ACID |
DADE MICROSCAN, INC. |
CYNTHIA VAN DUKER |
K020939 |
05/17/2002 |
MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE |
DADE MICROSCAN, INC. |
CYNTHIA VAN DUKER |
K012195 |
05/07/2002 |
STEAM STERILIZATION INTERGRATOR |
DANA PRODUCTS, INC. |
HARRY BALA |
K020760 |
05/03/2002 |
STARFLOW HV |
DANVILLE MATERIALS, INC. |
CRAIG R BRUNS |
K020513 |
05/16/2002 |
EPY-50 |
DDC TECHNOLOGIES, INC. |
DMITRY DONSKOY |
K020893 |
05/28/2002 |
NORAD NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE |
DENNIS R. BAILEY, DDS |
DENNIS R BAILEY |
K021416 |
05/13/2002 |
AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL |
DENTSPLY INTL. |
P. JEFFERY LEHN |
K021413 |
05/10/2002 |
AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL |
DENTSPLY INTL. |
P. JEFFERY LEHN |
K021410 |
05/08/2002 |
AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL |
DENTSPLY INTL. |
P. JEFFERY LEHN |
K021148 |
05/08/2002 |
MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD |
DEPUY ACROMED |
LISA GILMAN |
K020541 |
05/20/2002 |
AGILITY ANKLE REVISION PROSTHESIS |
DEPUY, INC. |
JANET G JOHNSON |
K020816 |
05/14/2002 |
IRON-PC-SL ASSAY MODEL # 151-10, 151-26 |
DIAGNOSTIC CHEMICALS LTD. |
NANCY OLSCAMP |
K021208 |
05/30/2002 |
IMMULITE 2000 MIXED ALLERGEN PANELS |
DIAGNOSTIC PRODUCTS CORP. |
ROBERT M DI TULLIO |
K021206 |
05/30/2002 |
IMMULITE 2000 SPECIFIC ALLERGENS |
DIAGNOSTIC PRODUCTS CORP. |
ROBERT M DI TULLIO |
K020945 |
05/31/2002 |
AXSYM INTACT PTH, MODEL 2G06 |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
CARROLL POTTS |
K020430 |
05/09/2002 |
DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK) |
DIATEK, INC. |
JON WILSON |
K021324 |
05/23/2002 |
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM) |
DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. |
YAEL RUBIN |
K020510 |
05/03/2002 |
SMOKE EVACUATION HOSES/TUBING |
DM MEDICAL INC. |
ROBERT W MAYS |
K020726 |
05/15/2002 |
DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE |
DUKAL CORP. |
PATRICK J LAMB |
K020887 |
05/16/2002 |
EBI AIS SPINE SYSTEM |
EBI, L.P. |
FREDERIC TESTA |
K021312 |
05/23/2002 |
EBI DFS OPTIROM ELBOW FIXATOR |
EBI, L.P. |
JON CAPAROTTA |
K021091 |
05/03/2002 |
EBI XFIX DFS SYSTEM |
EBI, L.P. |
FREDERIC TESTA |
K021031 |
05/16/2002 |
EBI XFIX RAIL SYSTEM |
EBI, L.P. |
MICHAEL T TAGGART |
K021102 |
05/08/2002 |
DM SLEEVE |
EMILY IKER M.D., A.P.C. |
JONATHAN S KAHAN |
K013712 |
05/31/2002 |
ENTERYX INJECTOR |
ENTERIC MEDICAL TECHNOLOGIES |
JILL M VISOR |
K020684 |
05/23/2002 |
FINESUN EMS STIMULATOR |
FINESUN WORLDWIDE INTL. CO., LTD. |
CHI-CHU WU CHEN |
K021108 |
05/03/2002 |
ESOP HA FEMORAL STEM |
FOURNITURES HOSPITALIERES |
ANDRE WEITH |
K020566 |
05/09/2002 |
FUJIREBIO DIAGNOSTICS CA 19-9 RIA |
FUJIREBIO DIAGNOSTICS, INC. |
DANIEL J O'SHANNESSY |
K021038 |
05/03/2002 |
GC ELITE CEMENT 100 |
GC AMERICA, INC. |
TERRY L JORITZ |
K021435 |
05/22/2002 |
DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MELISSA ROBINSON |
K021135 |
05/09/2002 |
MODEL 2120IS SERIES MATERNAL/FETAL MONITOR |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
JOELLE NEIDER |
K021491 |
05/22/2002 |
HISPEED DUAL |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
K021325 |
05/07/2002 |
MODIFICATION OF APEXPRO TELEMETRY SYSTEM |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
JOELLE NEIDER |
K020661 |
05/24/2002 |
UNITY IS PATIENT VIEWER |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
KAREN WEBB |
K021258 |
05/10/2002 |
GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER |
GERM TERMINATOR CORPORATION |
DAVID LINK |
K020341 |
05/02/2002 |
GIVEN DIAGNOSTIC SYSTEM |
GIVEN IMAGING LTD. |
SHOSHANA FRIEDMAN |
K021308 |
05/14/2002 |
GLOVCO POWDER-FREE NITRILE EXAMINATION GLOVES |
GLOVCO (M) SDN. BHD. |
TAN PENG HOCK |
K021284 |
05/02/2002 |
EASYTRAK GUIDING CATHETER |
GUIDANT CORP. |
KAREN S ALSOP |
K021283 |
05/02/2002 |
GUIDANT BALLOON CATHETER, SEVERAL MODELS |
GUIDANT CORP. |
KAREN S ALSOP |
K021228 |
05/15/2002 |
HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE |
GUIDANT CORP. |
JENNIFER PAE RIGGS |
K021285 |
05/02/2002 |
HI-TORQUE EXTRA S'PORT GUIDEWIRE |
GUIDANT CORP. |
KAREN S ALSOP |
K021282 |
05/02/2002 |
LV-1 HEMOSTASIS VALVE, MODEL #6789 |
GUIDANT CORP. |
KAREN S ALSOP |
K020701 |
05/24/2002 |
SYNCRUS INTERNAL CARDIOVERSION SYSTEM |
GUIDANT CORPORATION, CARDIAC SURGERY |
DEBBIE COGAN |
K020778 |
05/28/2002 |
GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420 |
GYRUS ENT L.L.C. |
JEFFERY W COBB |
K013615 |
05/29/2002 |
MICRO-INDUCTION 1000 SYSTEM |
HARBINGER MEDICAL, INC. |
HAROLD HOIUM |
K020643 |
05/28/2002 |
EZ-SCOPE AN & EZ-SCOPE AN LITE |
HEALTH POLICY RESORTERS GROUP, LLC |
T. WHIT ATHEY |
K021479 |
05/21/2002 |
CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 |
HEINZ KURZ GMBH MEDIZINTECHNIK |
DAGMAR MASER |
K020914 |
05/23/2002 |
ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 |
HELENA LABORATORIES |
PATRICIA FRANKS |
K020625 |
05/06/2002 |
SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 |
HELENA LABORATORIES |
PATRICIA FRANKS |
K013376 |
05/08/2002 |
QFLOW 500 PERFUSION MONITORING SYSTEM |
HEMEDEX INCORPORATED |
DEBBIE IAMPIETRO |
K020679 |
05/06/2002 |
INRATIO |
HEMOSENSE, INC. |
Judith Blunt |
K020652 |
05/15/2002 |
HERNIAMESH T-SLING |
HERNIAMESH |
LORENA TRABUCCO |
K020471 |
05/02/2002 |
HIVOX EAR THERMOMETER, TS SERIES |
HIVOX BIOTEK, INC. |
Ke-Min Jen |
K021310 |
05/21/2002 |
36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) |
HOWMEDICA OSTEONICS CORP. |
JENNIFER A DAUDELIN |
K020615 |
05/13/2002 |
SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS |
HOWMEDICA OSTEONICS CORP. |
WILLIAM J CYMBALUK |
K020384 |
05/06/2002 |
T2 ARTHRODESIS NAIL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
WILLIAM J CYMBALUK |
K020355 |
05/14/2002 |
I-STAT PROTHROMBIN TIME TEST |
I-STAT CORPORATION |
PAUL VANDERERF |
K020908 |
05/22/2002 |
HDM97 |
IBP INSTRUMENTS GMBH |
WERNER PFINGSTMANN |
K020909 |
05/22/2002 |
HDM99 |
IBP INSTRUMENTS GMBH |
WERNER PFINGSTMANN |
K020576 |
05/01/2002 |
VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE |
ID BIOMEDICAL CORP. |
DAVID CLARY |
K021163 |
05/10/2002 |
OCTEIA 25-HYDROXY VITAMIN D |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
PAUL PUNTIN |
K014235 |
05/16/2002 |
OSSEOTITE NT DENTAL IMPLANTS & ACCESSORIES |
IMPLANT INNOVATIONS, INC. |
JEANNETTE G DAILEY |
K021025 |
05/20/2002 |
MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ |
IMPLEX CORP. |
ROBERT POGGIE |
K021465 |
05/22/2002 |
MIDAS TOUCH LATEX EXAMINATION GLOVES-POLYMER COATED, POWDER FREE |
INDUSTRIAL CLOTHINGS, LTD. |
UMAIR AHMED |
K013021 |
05/30/2002 |
LIGHTLANCE LASER SKIN PERFORATOR |
INNOTECH USA, INC. |
HOWARD HOLSTEIN |
K021024 |
05/16/2002 |
HEMOSIL HIGH ABNORMAL CONTROL ASSAYED |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K021022 |
05/14/2002 |
HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED) |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K021023 |
05/14/2002 |
HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED) |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K021323 |
05/22/2002 |
MODIFICATION TO SAFE-STEER GUIDE WIRE SYSTEM |
INTRALUMINAL THERAPEUTICS, INC. |
PAMELA MISAJON |
K020849 |
05/20/2002 |
APEX 800 LASER SYSTEM, MODEL APEX 800 |
IRIDEX CORP. |
JOHN D'ANGELO |
K020374 |
05/03/2002 |
OCULIGHT SL/SLX |
IRIDEX CORP. |
JOHN D'ANGELO |
K013802 |
05/01/2002 |
FRC POSTEC |
IVOCLAR VIVADENT, INC. |
DONNA M HARTNETT |
K012496 |
05/17/2002 |
CARBON POST |
J. MORITA USA, INC. |
KEITH A BARRITT |
K021088 |
05/02/2002 |
JOGUIDE CARDIOVASCULAR GUIDING C ATHETER |
JOMED CATHETER, INC. |
NORMAN L HALL |
K021219 |
05/17/2002 |
SMARTWIRE/SMARTMAP PRESSURE SYSTEM |
JOMED, INC. |
TERRY SCHULTZ |
K020640 |
05/28/2002 |
KSEA SCB MEDIA CONTROL |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
JAMES A LEE |
K013982 |
05/21/2002 |
KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT |
KINAMED, INC. |
VINEET SARIN |
K020781 |
05/06/2002 |
WET CHAMBER |
KINETIC CONCEPTS, INC. |
JUITH A HARBOUR |
K020554 |
05/03/2002 |
MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM |
KINETIKOS MEDICAL, INC. |
FLOYD G LARSON |
K011859 |
05/01/2002 |
KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS |
KLIMAMED TECHNOLOGIE MEDIZINGERATE GMBH |
|
K020763 |
05/10/2002 |
COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT) |
Lin-Zhi International, Inc. |
CHIU CHIN CHANG |
K020254 |
05/10/2002 |
PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011 |
Lin-Zhi International, Inc. |
CHIU CHIN CHANG |
K020377 |
05/06/2002 |
PRE-LOADED BIOSTINGER HORNET |
LINVATEC CORP. |
LAURA D SENEFF |
K020633 |
05/15/2002 |
NATURAL AND COLORED LATEX CONDOM WITH FLAVORS |
LS RUBBER SDN BHD |
RAJILA VOHRA |
K020591 |
05/16/2002 |
BCLEAR |
LUMENIS |
C. ROBERT PAYNE JR. |
K020623 |
05/02/2002 |
DUOPRO SAFETY SYRINGE (DUOPROSS) |
M.K. MEDITECH CO. LTD. |
ROSINA ROBINSON |
K020562 |
05/16/2002 |
APEX INTRAMEDULLARY NAIL SYSTEM |
MAGLY ORTHOPEDICS, LLC |
DAVE STINSON |
K020993 |
05/21/2002 |
ILLUMINATOR AUTOMATIC TUNE VOX AND INTERFACE CABLE (ATIB) |
MAGNA-LAB, INC. |
JOHN GEISEL |
K021145 |
05/16/2002 |
ACCOMMODATOR WHEELCHAIR, MODEL #2000X |
MARKEN INTERNATIONAL, INC. |
STEVE RIFFEL |
K020393 |
05/03/2002 |
MASTER & FRANK SURGICAL DRAPES (STERILE) |
MASTER & FRANK ENTERPRSES CO.LTD. |
FRANK WU |
K020563 |
05/21/2002 |
MEDAMICUS AXIA RSN |
MEDAMICUS, INC. |
KARYL D HASKELL |
K020315 |
05/24/2002 |
14F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL |
MEDCOMP |
FLORENCE A CAIKOSKI |
K020465 |
05/22/2002 |
MEDCOMP ASH SPLIT-CATH II |
MEDCOMP |
FLORENCE A CAIKOSKI |
K021368 |
05/15/2002 |
MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057 |
MEDELA AG |
RERNER FREI |
K020780 |
05/20/2002 |
TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP |
MEDEX, INC. |
BARBARA LAW |
K012979 |
05/08/2002 |
COMPRESSIBLE LIMB SLEEVE |
MEDICAL DEVICE SERVICES, INC. |
RON EAMES |
K021606 |
05/31/2002 |
EN-SNARE ENDOVASCULAR SNARE AND CATHETER |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
K012614 |
05/01/2002 |
KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN |
MEDICAL INSTRUMENTS TECHNOLOGY, INC. |
JACK SPEER |
K021171 |
05/08/2002 |
Q-STRESS ECHO BED |
MEDICAL POSITIONING, INC. |
CAROL PATTERSON |
K020512 |
05/16/2002 |
MTI ST#1 SILICONE PESSARY |
MEDICAL TECHNOLOGY AND INNOVATIONS, INC. |
LARRY W JAMES |
K020787 |
05/02/2002 |
VERDICT-II PROPOXYPHENE |
MEDTOX DIAGNOSTICS, INC. |
MICHAEL TURANCHIK |
K021287 |
05/07/2002 |
TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT |
MEDTRONIC PERFUSION SYSTEMS |
PREETI JAIN |
K020709 |
05/09/2002 |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K021226 |
05/13/2002 |
MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K021106 |
05/03/2002 |
MODIFICATION TO TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
K020699 |
05/28/2002 |
TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
K021589 |
05/30/2002 |
ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218 |
MEDTRONIC VASCULAR |
KAREN REIDT |
K021587 |
05/30/2002 |
ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A |
MEDTRONIC VASCULAR |
KAREN REIDT |
K021256 |
05/17/2002 |
Z3 GUIDE CATHETER |
MEDTRONIC VASCULAR |
FRED L BOUCHER |
K020930 |
05/02/2002 |
MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES |
MENICON CO. LTD. |
BEVERLEY D VENUTI |
K020466 |
05/08/2002 |
HEC 1000 |
METRO MEDICAL EQUIPMENT, INC. |
PAUL MOCUR |
K020956 |
05/16/2002 |
VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA |
MICROTEK MEDICAL, INC. |
THOMAS BONNER |
K011726 |
05/16/2002 |
MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER |
MILLENIUM BIOLOGIX, INC. |
ROBERT SCHIFF |
K013888 |
05/01/2002 |
FIXATION (STEINMANN) PINS |
MILTEX, INC. |
RICHARD GORDON |
K013258 |
05/31/2002 |
INPATH E2 COLLECTOR |
MOLECULAR DIAGNOSTICS |
ROBERT L HABIG |
K021255 |
05/02/2002 |
Y.E.S 10 WHEELCHAIR |
MOVINGPEOPLE.NET |
PEGGY SPILIADIS |
K013053 |
05/09/2002 |
MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING |
NANMA MFG CO., LTD. |
YOLANDA SMITH |
K021090 |
05/08/2002 |
OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER |
NELLCOR PURITAN BENNETT, INC. |
GINA TO |
K021577 |
05/29/2002 |
MODIFICATION TO EN-BLOC BIOPSY SYSTEM |
NEOTHERMIA CORP. |
SHERRIE COVAL-GOLDSMITH |
K020584 |
05/22/2002 |
N2000 BASE STATION; N2001 NURSE STATION |
NEPTEC DESIGN GROUP, LTD. |
CHARLES H KYPER |
K013827 |
05/21/2002 |
TST - SUPPRESSOR MODEL #1000 |
NEUROSIM LIMITED |
IAN BROWN |
K020797 |
05/03/2002 |
PULMO-MIST COMPRESSOR MODEL # 4323 |
NIDEK MEDICAL PRODUCTS, INC. |
L. G SUELTER |
K020876 |
05/03/2002 |
ECHOSCAN, MODEL US-1800 |
NIDEK, INC. |
CAROL PATTERSON |
K020646 |
05/29/2002 |
REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162 |
NOBEL BIOCARE UAS INC |
VINCENT CHEUNG |
K012712 |
05/08/2002 |
NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 |
NORAV MEDICAL LTD. |
STEVE SPRINGROSE |
K020617 |
05/10/2002 |
NSI HEXED AND NON-HEXED IMPLANT SYSTEM |
NSI |
GRETA M HOLS |
K021286 |
05/23/2002 |
MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT DEVICES AND 105.988 FOR 230VOLT DEVICES |
NUCLETRON CORP. |
LISA DIMMICK |
K020547 |
05/09/2002 |
OHMEDA MEDICAL GIRAFFE INCUBATOR |
OHMEDA MEDICAL |
ALBERTO F PROFUMO |
K020543 |
05/09/2002 |
OHMEDA MEDICAL GIRAFFE OMNIBED |
OHMEDA MEDICAL |
ALBERTO F PROFUMO |
K021074 |
05/02/2002 |
VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TYLER |
K021073 |
05/01/2002 |
VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TYLER |
K021204 |
05/01/2002 |
OLYMPUS BF TYPE UM40 |
OLYMPUS OPTICAL CO., LTD. |
LAURA STORMS-TYLER |
K021082 |
05/22/2002 |
ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.0 |
ON SITE GAS SYSTEMS, INC. |
C. BARTON GULLONG |
K013390 |
05/23/2002 |
QUICKCLOT |
ON SITE GAS SYSTEMS, INC. |
C. BURTON GULLONG |
K021105 |
05/10/2002 |
FORTAFLEX SURGICAL MESH |
ORGANOGENESIS, INC. |
MICHAEL L SABOLINSKI |
K021107 |
05/15/2002 |
FORTAFLEX SURGICAL SLING |
ORGANOGENESIS, INC. |
MICHAEL L SABOLINSKI |
K020383 |
05/06/2002 |
ORTHO DEVELOPMENT BALANCED KNEE TIBIAL TRAY PEGGED |
ORTHO DEVELOPMENT CORP. |
CAROL FREASIER |
K021379 |
05/31/2002 |
SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06 |
ORTHO TEC LLC |
KAREN E WARDEN |
K013764 |
05/16/2002 |
IMMIX BONE GRAFT EXTENDER |
OSTEOGENICS BIOMEDICAL, INC. |
RICHARD A HAMER |
K021331 |
05/21/2002 |
DEXACARE G4 |
OSTEOMETER MEDITECH, INC. |
RAJA KRISHNAMURTI |
K020203 |
05/08/2002 |
PADPRO MODEL #2516 |
PADPRO LLC. |
DANIEL KAMM |
K020743 |
05/28/2002 |
PADPRO, MODEL 2502 |
PADPRO LLC. |
DANIEL KAMM |
K020453 |
05/10/2002 |
PALOMAR ESTELUX PULSED LIGHT SYSTEM AND PALOMAR COOLROLLER |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
Marcy Moore |
K020944 |
05/09/2002 |
VORTEX VALVED HOLDING CHAMBER |
PARI INNOVATIVE MANUFACTURERS, INC. |
LAWRENCE WEINSTEIN |
K021409 |
05/24/2002 |
AT HOME OVULATION TEST, MODEL 9032 |
PHAMATECH INC. |
CARL A MONGIOVI |
K020757 |
05/02/2002 |
VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796 |
PHARMACIA DEUTSCHLAND GMBH |
MICHAEL LINSS |
K020752 |
05/02/2002 |
VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596 |
PHARMACIA DEUTSCHLAND GMBH |
MICHAEL LINSS |
K020758 |
05/02/2002 |
VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696 |
PHARMACIA DEUTSCHLAND GMBH |
MICHARL LINSS |
K021514 |
05/16/2002 |
PHILIPS PLS9W/12/2P UVB |
PHILIPS LIGHTING CO. |
TONI J HOFFMANN |
K021092 |
05/16/2002 |
PHILIPS TL 20W/01RS UV-B, PHILIPS PL-S 9W/01/2P UV, AND PHILIPS PL-L 36W/01/4P UV-B |
PHILIPS LIGHTING CO. |
TONI J HOFFMANN |
K021300 |
05/08/2002 |
MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B |
PHILIPS MEDICAL SYSTEMS |
DAVE OSBORN |
K021347 |
05/07/2002 |
MODIFICATION TO M2376A DEVICELINK SYSTEM |
PHILIPS MEDICAL SYSTEMS |
DENISE HALEY |
K021422 |
05/15/2002 |
PHILIPS INFORMATION CENTER SOFTWARE REVISION D.02 |
PHILIPS MEDICAL SYSTEMS |
DAVE OSBORN |
K021251 |
05/07/2002 |
ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I. |
PHILIPS MEDICAL SYSTEMS |
DAVE OSBORN |
K020847 |
05/16/2002 |
XTRAC EXCIMER LASER SYSTEM, MODEL AL7000 |
PHOTO MEDEX, INC. |
BOB ROSE |
K020298 |
05/20/2002 |
GALILEO CAS/NAV TKR SYSTEM |
PLUS ORTHOPEDICS |
HARTMUT LOCH |
K021178 |
05/14/2002 |
SL-PLUS LATERALIZED STEM |
PLUS ORTHOPEDICS |
HARTMUT LOCH |
K020608 |
05/16/2002 |
HD/HDT, (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS) |
POLY VUE TECHNOLGIES, INC. |
DEANNA WERBER |
K021249 |
05/15/2002 |
SURGASSIST FLEXSHAFT 2, MODEL FS2 14 |
POWER MEDICAL INTERVENTIONS, INC. |
BARBARA J WHITMAN |
K020719 |
05/10/2002 |
SURGASSIST SYSTEM STRAIGHT LINEAR CUTTER DIGITAL LOADING UNIT, 55MM, 30MM WITH BLUE AND GREEN RELOAD CARTRIDGES |
POWER MEDICAL INTERVENTIONS, INC. |
BARBARA J WHITMAN |
K013846 |
05/22/2002 |
ULTRAGARD IMPERVIOUS REINFORCED GOWN |
PRECEPT MEDICAL PRODUCTS, INC. |
MARY ANN FAULKNER |
K013787 |
05/14/2002 |
NYCOCARD CRP |
PRIMUS CORP. |
JIMMIE K NOFFSINGER |
K021065 |
05/08/2002 |
PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM |
PRIMUS GLOVES PRIVATE LTD. |
JOSEPH J E PEREIRA |
K014193 |
05/23/2002 |
LIFESIGN DOA 4 (THC/OPI/COC/MET) |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
K014192 |
05/23/2002 |
LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
K020439 |
05/23/2002 |
STATUS HCG SERUM/URINE |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
K012716 |
05/07/2002 |
MAINSTREAM WATER PURIFICATION DEVICE |
PRISMEDICAL CORP. |
ELAINE ALAMBRA |
K011690 |
05/06/2002 |
MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY |
PROXIMA THERAPEUTICS, INC. |
MARTINE D SCHNEIDER |
K011426 |
05/03/2002 |
PSYCHEMEDICS RIA CANNABINOID ASSAY |
PSYCHEMEDICS CORP. |
WILLIAM R THISTLE |
K020514 |
05/16/2002 |
PULPDENT GLAZE II |
PULPDENT CORPORATION |
KENNETH J BERK |
K020587 |
05/23/2002 |
PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046 |
PULSION MEDICAL SYSTEMS AG |
JAMES M DELANEY |
K020801 |
05/17/2002 |
QUICKVUE ONE-STEP HCG-COMBO |
QUIDEL CORP. |
JENNIFER S HANKARD |
K020799 |
05/17/2002 |
QUICKVUE ONE-STEP HCG-URINE |
QUIDEL CORP. |
JENNIFER S HANKARD |
K020716 |
05/06/2002 |
RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS) |
RAPID DIAGNOSTICS, INC. |
CHARLES C.F. YU |
K021531 |
05/31/2002 |
RPI REPLACEMENT PHOTOTHERAPY LIGHTS |
REPLACEMENT PARTS INDUSTRIES, INC. |
IRA LAPIDES |
K014126 |
05/03/2002 |
SANIDAD HEALTH-UP TENS MP-73725 |
ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY |
JEN KE-MIN |
K013646 |
05/30/2002 |
ROSE K POST GRAFT LENS |
ROSE K INTERNATIONAL LTD. |
IAN JENNINGS |
K021225 |
05/22/2002 |
ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I |
ROSSMAX INTERNATIONAL LTD. |
MICHAEL YEH |
K020535 |
05/09/2002 |
INTERLUDE AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS |
ROSTAM LTD. |
ROBERT J STAAB |
K020053 |
05/01/2002 |
SAFE SHIELD POWEDER-FREE LATEX EXAMINATION GLOVES |
SAFE SHIELD CO. LTD |
SUSAN D GOLDSTEIN-FALK |
K020823 |
05/14/2002 |
PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT |
SANQUIN BLOOD SUPPLY FOUNDATION |
SUSAN D GOLDSTEIN-FALK |
K020476 |
05/03/2002 |
MEDION 6000 |
SELECTIVE MED COMPONENTS, INC. |
RICHARD FISHER |
K021246 |
05/13/2002 |
SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3 |
SENSIDYNE, INC. |
GEORGE MASON |
K020902 |
05/20/2002 |
SERRALESTER |
SERRAL, S.A. DE C.V. |
SCOTT HENDERSON |
K021000 |
05/31/2002 |
SHANGHAI GLOVMAX ENTERPRISE POWDERED BLUE NITRILE EXAMINATION GLOVES |
SHANGHAI GLOVMAX ENTERPRISE CO.,LTD |
SUSAN D GOLDSTEIN-FALK |
K021001 |
05/16/2002 |
SHANGHAI GLOVMAX ENTERPRISE POWDERFREE BLUE NITRILE EXAMINATION GLOVES |
SHANGHAI GLOVMAX ENTERPRISE CO.,LTD |
SUSAN D GOLDSTEIN-FALK |
K021013 |
05/22/2002 |
SMART GLOVE STERILE NITRILE EXAMINATION GLOVES (POWDERED FREE) |
SMART GLOVE CORP. SDN BHD |
NG YEW SOON |
K020642 |
05/24/2002 |
SOFT K. AND SOFT K. TORIC (XYLOFICON A) SOFT (HYDROPHILLIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR |
SOFLEX CONTACT LENS INDUSTRIES LTD. |
Kevin Walls |
K021628 |
05/31/2002 |
SONOSITE HAND-CARIED UNTRASOUND SYSTEM (POWERSERIES) |
SONOSITE,INC. |
MICHAEL A HOFFMAN |
K020950 |
05/24/2002 |
SPECTRAL'S 2 IN 1 (TNI-MYO) |
SPECTRAL DIAGNOSTICS, INC. |
NISAR SHAIKH |
K021212 |
05/17/2002 |
24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS |
SPIRE BIOMEDICAL INC |
DONALD FICKETT |
K020917 |
05/06/2002 |
SAVIEW 55F (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR |
ST. SHINE OPTICAL CO., LTD. |
Kevin Walls |
K020734 |
05/16/2002 |
SURGE-FREE ASPIRATION ADAPTER |
STAAR SURGICAL CO. |
HERB CRANE |
K013484 |
05/02/2002 |
TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH |
STEREOTAXIS, INC. |
PETER A TAKES |
K020664 |
05/14/2002 |
STERISHARP 3-GALLON RSDC, MODEL RSDC3G |
STERILOGIC WASTE SYSTEMS, INC. |
ERIK R SYNNESTVEDT |
K020747 |
05/17/2002 |
AMSCO CENTURY MEDIUM STERILIZER 26 X 26 |
STERIS Corporation |
LORI HALLER |
K021487 |
05/17/2002 |
SIMPLICITY EASY ACCESS P INFUSION SET |
STERLING MEDIVATIONS, INC. |
JOEL DOUGLAS |
K021530 |
05/21/2002 |
SIMPLICITY EASY P SOFT INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN |
STERLING MEDIVATIONS, INC. |
JOEL DOUGLAS |
K021296 |
05/14/2002 |
SIMPLICITY QD EASY P INFUSION SET |
STERLING MEDIVATIONS, INC. |
JOEL S DOUGLAS |
K021216 |
05/03/2002 |
SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADIGM INFUSION PUMPS |
STERLING MEDIVATIONS, INC. |
JOEL DOUGLAS |
K021367 |
05/16/2002 |
STERNGOLD 66, MODEL #1180230 |
STERNGOLD |
MARIA RAO |
K013687 |
05/28/2002 |
NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER |
STEVEN K. SUE |
STEVEN K SUE |
K021126 |
05/13/2002 |
EVERSTICK ORTHO |
STICK TECH LTD. |
WILLIAM TROETEL |
K020612 |
05/07/2002 |
SULTAN SPOROX TEST VIAL, MODEL 75195 |
SULTAN CHEMISTS, INC. |
CLARK SMITH |
K021563 |
05/31/2002 |
INTRACOIL SELF-EXPANDING PERIPHERAL STENT |
SULZER INTRATHERAPEUTICS, INC. |
MARIA E BRITTLE |
K020713 |
05/14/2002 |
MS-30 LATERAL FEMORAL STEM |
SULZER ORTHOPEDICS, INC. |
FRANCES E HARRISON |
K020344 |
05/02/2002 |
RPX TITANIUM CEMNT RESTRICTOR |
SULZER SPINE-TECH |
ANGELA BYLAND |
K021371 |
05/16/2002 |
SUNSPEX TECHNOLOGIES MODEL SE 02 |
SUNPEX TECHNOLOGY CO., LTD. |
JUDY HSU |
K020790 |
05/21/2002 |
INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL MICROCOIL, AND INTERCEPT VASCULAR INTERNAL MR COIL |
SURGI-VISION, INC. |
NANCY E TAYLOR |
K020033 |
05/31/2002 |
MAXISTAT PVA FOAM EMBOLIZATION PARTICLES |
SURGICA CORP. |
LOU MATSON |
K012658 |
05/14/2002 |
REPROCESSED COMPRESSION LIMB SLEEVES |
SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC. |
ROBERT S MCQUATE |
K020952 |
05/30/2002 |
SURX RF SYSTEM |
SURX, INC. |
ALAN CURTIS |
K020502 |
05/01/2002 |
SOLO ORTHO 3 |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
K021059 |
05/14/2002 |
SYNTEX POWDER-FREE LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM |
SYNTEX HEALTHCARE PRODUCTS CO. LTD. |
TAN SWU CHOON |
K021058 |
05/14/2002 |
SYNTEX POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM |
SYNTEX HEALTHCARE PRODUCTS CO. LTD. |
TAN SWU CHOON |
K020751 |
05/02/2002 |
SYNTEX POWDER-FREE POLYMER-COATED NITRILE EXAMINATION GLOVE |
SYNTEX HEALTHCARE PRODUCTS CO. LTD. |
TAN SWU CHOON |
K020602 |
05/20/2002 |
SYNTHES PILON PLATE |
SYNTHES |
MATTHEW M HULL |
K021382 |
05/16/2002 |
SYNTHES (USA) AUTOMATED TACK DRIVER |
SYNTHES (USA) |
BONNIE J SMITH |
K020401 |
05/08/2002 |
SYNTHES CALCANEAL PLATE |
SYNTHES (USA) |
MATTHEW M HULL |
K020379 |
05/06/2002 |
PPD BALLOON DILATATION CATHETER |
TELEMED SYSTEMS, INC. |
MICHAEL CARROLL |
K020846 |
05/21/2002 |
ULTIMA TENS XL-A1 |
TENS CARE LTD. |
BERNARD J TREMAINE |
K020445 |
05/10/2002 |
THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG |
THE ELECTRODE STORE, INC. |
CARL YOUNGMANN |
K021245 |
05/03/2002 |
DEGOTZEN SYNCHRO |
THE GOTZEN GROUP, INC. |
DONALD R HILL |
K021132 |
05/15/2002 |
UNI-PATCH ULTRASOUND COUPLING GEL |
THE LUDLOW COMPANY LP |
M. BETH RICE |
K021042 |
05/15/2002 |
THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS; MODELS # 7456, 7457, 7458,7459,7475,7476 |
THERMO FORMA, INC. |
RICHARD L MILLER |
K021117 |
05/02/2002 |
TTI THERMOMED MODEL 1.8 INSTRUMENT |
THERMOSURGERY TECHNOLOGIES, INC. |
GENE R HEDIN |
K011727 |
05/02/2002 |
TRANSSEPTAL NEEDLE/TROCAR |
THOMAS MEDICAL PRODUCTS, INC. |
TIM STOUDT |
K020574 |
05/20/2002 |
TISSUELINK BIPOLAR FLOATING BALL DEVICE |
TISSUELINK MEDICAL, INC. |
VICKI S ANASTASI |
K021374 |
05/30/2002 |
TOESCO AQUA BLUE LED LIGHT CURING DEVICE |
TOEI ELECTRIC CO., LTD. |
SUSAN D GOLDSTEIN-FALK |
K020561 |
05/09/2002 |
SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN |
TOMTEC IMAGING SYSTEMS, GMBH |
FLORIAN EISENBERGER |
K020489 |
05/14/2002 |
G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE |
TOSOH MEDICS, INC. |
LOIS NAKAYAMA |
K020859 |
05/15/2002 |
CEFOTAXIME |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
K020762 |
05/09/2002 |
GATIFLOXIN |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
K021339 |
05/09/2002 |
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNITHIA C KNAPP |
K020720 |
05/07/2002 |
OSSIFORM |
UNICARE BIOMEDICAL, INC. |
STAN YANG |
K021262 |
05/21/2002 |
MAGNETOM SYMPHONY QUADRATURE TX/RX HEAD COIL |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
K021268 |
05/22/2002 |
ECLIPSE, HELIOS OPTION |
VARIAN MEDICAL SYSTEMS, INC. |
LINDA S NASH |
K020113 |
05/17/2002 |
VECTOR F SERIES HIGH-SPEED DENTAL HANDPIECES |
VECTOR RESEARCH & DEVELOPMENT |
DANIEL KAMM |
K020567 |
05/02/2002 |
AKUPORT M1 |
VIBRANT HEALTH |
STEPHEN EMOND |
K021344 |
05/24/2002 |
B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM |
VISION-SCIENCES, INC. |
PAMELA PAPINEAU |
K020840 |
05/15/2002 |
VITAL SCIENTIFIC PT WITH CALCIUM |
VITAL SCIENTIFIC N.V. |
ISRAEL M STEIN |
K014068 |
05/03/2002 |
ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115 |
W & H DENTALWERK BUERMOOS GMBH |
RALF BENDA |
K021522 |
05/21/2002 |
LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW |
WALTER LORENZ SURGICAL, INC. |
SHERYL MALMBERG |
K020673 |
05/30/2002 |
WAVE FORM MANUFACTURING PROLASE GENERAL SHAPED FIBER |
WAVE FORM MFG., INC. |
JOE D BROWN |
K012800 |
05/03/2002 |
SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM |
WHITESIDE BIOMECHANICS, INC. |
DEBRA MEYER |
K020774 |
05/22/2002 |
IMAGINE H.E. PRESS DESIGN-CERAMIC |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
K021242 |
05/16/2002 |
PORTALLOY 54 |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
K020788 |
05/08/2002 |
WILSON-COOK ZILVER BILIARY STENT |
WILSON-COOK MEDICAL, INC. |
MARGARET J POSNER |
K020867 |
05/20/2002 |
BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL BMHN1104VX, & BONE MARROW BIOPSY NEEDL |
WORLDWIDE MEDICAL TECHNOLOGIES, LLC |
GARY LAMOUREUX |
K021396 |
05/16/2002 |
DERMAGRIP AND MULTIPLE POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NON-STERILE |
WRP SPECIALTY PRODUCTS SDN. BHD. |
V. NADARAJAN |
K021095 |
05/17/2002 |
HOLY DRAGON BRAND ACUPUNCTURE NEEDLES |
WUJIANG CITY HUA XIN MEDICAL APPLIANCE CO., LTD. |
LAURA J THORNE |