| MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING (K013053) | Nanma Mfg Co., Ltd. | 2002-05-09 |
| MODIFICATION TO CD HORIZON SPINAL SYSTEM (K020709) | Medtronic Sofamor Danek | 2002-05-09 |
| OHMEDA MEDICAL GIRAFFE OMNIBED (K020543) | Ohmeda Medical | 2002-05-09 |
| INTERLUDE AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS (K020535) | Rostam , Ltd. | 2002-05-09 |
| DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131 (K020724) | Dade Behring, Inc. | 2002-05-09 |
| MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME (K020820) | Dade Behring, Inc. | 2002-05-09 |
| DIMENSION ALDL CALIBRATOR, MODEL DC131 (K020723) | Dade Behring, Inc. | 2002-05-08 |
| EMIT 2000 VANCOMYCIN CALIBRATORS (K020845) | Dade Behring, Inc. | 2002-05-08 |
| DM SLEEVE (K021102) | Emily Iker M.D., A.P.C. | 2002-05-08 |
| HEC 1000 (K020466) | Metro Medical Equipment, Inc. | 2002-05-08 |
| ONLINE POWDER FREE, LATEX EXAMINATION GLOVES (K020865) | Apl Products Sdn. Bhd. | 2002-05-08 |
| PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM (K021065) | Primus Gloves Private , Ltd. | 2002-05-08 |
| MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER (K020634) | Atrium Medical Corp. | 2002-05-08 |
| AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL (K021410) | Dentsply Intl. | 2002-05-08 |
| MICROJET CRONO PCA (K013822) | Cane S.R.L. | 2002-05-08 |
| MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B (K021300) | Philips Medical Systems | 2002-05-08 |
| SYNTHES CALCANEAL PLATE (K020401) | Synthes (Usa) | 2002-05-08 |
| COMPRESSIBLE LIMB SLEEVE (K012979) | Medical Device Services, Inc. | 2002-05-08 |
| QFLOW 500 PERFUSION MONITORING SYSTEM (K013376) | Hemedex Incorporated | 2002-05-08 |
| WILSON-COOK ZILVER BILIARY STENT (K020788) | Wilson-Cook Medical, Inc. | 2002-05-08 |
| MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - VANCOMYCIN (K020822) | Dade Behring, Inc. | 2002-05-08 |
| PADPRO MODEL #2516 (K020203) | Padpro, LLC | 2002-05-08 |
| NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 (K012712) | Norav Medical , Ltd. | 2002-05-08 |
| Q-STRESS ECHO BED (K021171) | Medical Positioning, Inc. | 2002-05-08 |
| OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER (K021090) | Nellcor Puritan Bennett, Inc. | 2002-05-08 |
| ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE (K020313) | Acon Laboratories Co. | 2002-05-08 |
| MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD (K021148) | Depuyacromed | 2002-05-08 |
| STEAM STERILIZATION INTERGRATOR (K012195) | Dana Products, Inc. | 2002-05-07 |
| MODIFICATION OF APEXPRO TELEMETRY SYSTEM (K021325) | General Electric Medical Systems Information Techn | 2002-05-07 |
| ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I. (K021251) | Philips Medical Systems | 2002-05-07 |
| SULTAN SPOROX TEST VIAL, MODEL 75195 (K020612) | Sultan Chemists, Inc. | 2002-05-07 |
| TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT (K021287) | Medtronic Perfusion Systems | 2002-05-07 |
| MAINSTREAM WATER PURIFICATION DEVICE (K012716) | Prismedical Corp. | 2002-05-07 |
| MODIFICATION TO M2376A DEVICELINK SYSTEM (K021347) | Philips Medical Systems | 2002-05-07 |
| HIGH SILVER CONVENTIONAL (K020452) | Ab Ardent | 2002-05-07 |
| OSSIFORM (K020720) | Unicare Biomedical, Inc. | 2002-05-07 |
| MICROSCAN MICROSTREP PLUS PANEL-AMOXICILLIN/CLAVULANIC ACID (K020937) | Dade Microscan, Inc. | 2002-05-06 |
| MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-GATIFLOXACIN (K020627) | Dade Microscan, Inc. | 2002-05-06 |
| PRE-LOADED BIOSTINGER HORNET (K020377) | Linvatec Corp. | 2002-05-06 |
| ORTHO DEVELOPMENT BALANCED KNEE TIBIAL TRAY PEGGED (K020383) | Ortho Development Corp. | 2002-05-06 |
| MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY (K011690) | Proxima Therapeutics, Inc. | 2002-05-06 |
| INRATIO (K020679) | Hemosense, Inc. | 2002-05-06 |
| MICROSTREP PLUS PANEL WITH AMPICILLIN (K021037) | Dade Behring, Inc. | 2002-05-06 |
| SAVIEW 55F (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR (K020917) | St. shine Optical Co., Ltd. | 2002-05-06 |
| EXPANDABLE KNEE (K020381) | Biomet Orthopedics, Inc. | 2002-05-06 |
| PPD BALLOON DILATATION CATHETER (K020379) | Telemed Systems, Inc. | 2002-05-06 |
| WET CHAMBER (K020781) | Kinetic Concepts, Inc. | 2002-05-06 |
| T2 ARTHRODESIS NAIL SYSTEM (K020384) | Howmedica Osteonics Corp. | 2002-05-06 |
| SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 (K020625) | Helena Laboratories | 2002-05-06 |
| RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS) (K020716) | Rapid Diagnostics, Inc. | 2002-05-06 |
| THE NURTURE III BREAST PUMP (K020375) | Bailey Medical Engineering | 2002-05-03 |
| EBI XFIX DFS SYSTEM (K021091) | Ebi, L.P. | 2002-05-03 |
| MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM (K020554) | Kinetikos Medical, Inc. | 2002-05-03 |
| PSYCHEMEDICS RIA CANNABINOID ASSAY (K011426) | Psychemedics Corp. | 2002-05-03 |
| MASTER & FRANK SURGICAL DRAPES (STERILE) (K020393) | Master & Frank Enterprses Co., Ltd. | 2002-05-03 |
| GC ELITE CEMENT 100 (K021038) | GC America, Inc. | 2002-05-03 |
| SMOKE EVACUATION HOSES/TUBING (K020510) | Dm Medical, Inc. | 2002-05-03 |
| ECHOSCAN, MODEL US-1800 (K020876) | Nidek, Inc. | 2002-05-03 |
| 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE (K020365) | 3t Medical Systems, LLC | 2002-05-03 |
| ESOP HA FEMORAL STEM (K021108) | Fournitures Hospitalieres | 2002-05-03 |
| MEDION 6000 (K020476) | Selectivemed Components, Inc. | 2002-05-03 |
| ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115 (K014068) | W&H Dentalwerk Buermoos GmbH | 2002-05-03 |
| OCULIGHT SL/SLX (K020374) | Iridex Corp | 2002-05-03 |
| SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM (K012800) | Whiteside Biomechanics, Inc. | 2002-05-03 |
| BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL) (K020354) | Baylis Medical Co., Inc. | 2002-05-03 |
| MODIFICATION TO TSRH SPINAL SYSTEM (K021106) | Medtronic Sofamor Danek, Inc. | 2002-05-03 |
| DEGOTZEN SYNCHRO (K021245) | The Gotzen Group, Inc. | 2002-05-03 |
| INDWELLING FECAL MANAGEMENT SYSTEM (K012113) | Bowel Management Systems, LLC | 2002-05-03 |
| SANIDAD HEALTH-UP TENS MP-73725 (K014126) | Roc Chinese-European Industrial Research Society | 2002-05-03 |
| SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADIGM INFUSION PUMPS (K021216) | Sterling Medivations, Inc. | 2002-05-03 |
| STARFLOW HV (K020760) | Danville Materials, Inc. | 2002-05-03 |
| PULMO-MIST COMPRESSOR MODEL # 4323 (K020797) | Nidek Medical Products, Inc. | 2002-05-03 |
| ACE HA SCREW DENTAL IMPLANT SYSTEM (K021244) | Ace Surgical Supply Co., Inc. | 2002-05-03 |
| LV-1 HEMOSTASIS VALVE, MODEL #6789 (K021282) | Guidant Corp. | 2002-05-02 |
| GUIDANT BALLOON CATHETER, SEVERAL MODELS (K021283) | Guidant Corp. | 2002-05-02 |
| VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596 (K020752) | Pharmacia Deutschland GmbH | 2002-05-02 |
| TTI THERMOMED MODEL 1.8 INSTRUMENT (K021117) | Thermosurgery Technologies, Inc. | 2002-05-02 |
| HIVOX EAR THERMOMETER, TS SERIES (K020471) | Hivox Biotek, Inc. | 2002-05-02 |
| TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH (K013484) | Stereotaxis, Inc. | 2002-05-02 |
| AKUPORT M1 (K020567) | Vibrant Health | 2002-05-02 |
| TRANSSEPTAL NEEDLE/TROCAR (K011727) | Thomas Medical Products, Inc. | 2002-05-02 |
| GIVEN DIAGNOSTIC SYSTEM (K020341) | Given Imaging , Ltd. | 2002-05-02 |
| EASYTRAK GUIDING CATHETER (K021284) | Guidant Corp. | 2002-05-02 |
| MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES (K020930) | Menicon Co, Ltd. | 2002-05-02 |
| VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796 (K020757) | Pharmacia Deutschland GmbH | 2002-05-02 |
| VERDICT-II PROPOXYPHENE (K020787) | Medtox Diagnostics, Inc. | 2002-05-02 |
| DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300 (K020687) | Axis-Shield Diagnostics, Ltd. | 2002-05-02 |
| VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696 (K020758) | Pharmacia Deutschland GmbH | 2002-05-02 |
| SYNTEX POWDER-FREE POLYMER-COATED NITRILE EXAMINATION GLOVE (K020751) | Syntex Healthcare Products Co., Ltd. | 2002-05-02 |
| JOGUIDE CARDIOVASCULAR GUIDING C ATHETER (K021088) | Jomed Catheter, Inc. | 2002-05-02 |
| HI-TORQUE EXTRA S'PORT GUIDEWIRE (K021285) | Guidant Corp. | 2002-05-02 |
| VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA (K021074) | Olympus America, Inc. | 2002-05-02 |
| ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS (K020349) | Axis-Shield Diagnostics, Ltd. | 2002-05-02 |
| RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP (K021120) | Arrow Intl., Inc. | 2002-05-02 |
| Y.E.S 10 WHEELCHAIR (K021255) | Movingpeople.Net | 2002-05-02 |
| RPX TITANIUM CEMNT RESTRICTOR (K020344) | Sulzer Spine-Tech | 2002-05-02 |
| DUOPRO SAFETY SYRINGE (DUOPROSS) (K020623) | M.K. Meditech Co. , Ltd. | 2002-05-02 |
| ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS (K020348) | Axis-Shield Diagnostics, Ltd. | 2002-05-02 |
| SYSTEM 2000 CONTROLLER, SYSTEM 5000 CONTROLLER, FOOTSWITCH, POWER CORD, AND VISAGE WANDSFF (K020408) | Arthrocare Corp. | 2002-05-02 |
| VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V (K021073) | Olympus America, Inc. | 2002-05-01 |