| ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE (K021445) | Ab Biodisk | 2002-06-06 |
| MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN (K021078) | Dade Microscan, Inc. | 2002-06-06 |
| POWDERED (BLUE) NITRILE PATIENT EXAMINATION GLOVES (K021506) | Shijiazhuang Great Vision Plastic Products Co., LT | 2002-06-06 |
| NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K021220) | Siam Sempermed Corp., Ltd. | 2002-06-06 |
| GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4 (K021494) | Boston Scientific, Target | 2002-06-06 |
| M3 (MICRO-MULTILEAF COLLIMATOR) (K020860) | Brainlab AG | 2002-06-06 |
| STERILE DISPOSABLE VINYL EXAM GLOVES, POWDER FREE (K020943) | Shanghai Antares Industries, Inc. | 2002-06-06 |
| VAXCEL PICC WITH PASV VALVE TECHNOLOGY (K021704) | Catheter Innovations, Inc. | 2002-06-06 |
| GPF-29 GENERAL PURPOSE COIL SET (K020850) | Mri Devices Corp. | 2002-06-06 |
| SCORPIO INSET PATELLAR COMPONENT (K020830) | Howmedica Osteonics Corp. | 2002-06-06 |
| HBS HEADLESS BONE SCREW (K020791) | Millennium Medical Technologies, Inc. | 2002-06-06 |
| MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS (K021021) | Siemens Medical Solutions USA, Inc. | 2002-06-06 |
| OSCAR, MODEL OE3000 (K021502) | Orthosonics, Ltd. | 2002-06-06 |
| MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME (K021111) | Dade Microscan, Inc. | 2002-06-06 |
| ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840 (K021462) | Arrow Intl., Inc. | 2002-06-06 |
| PAINDOC (K021518) | Advanced Neuromodulation Systems | 2002-06-06 |
| FILMSAVER, NT VERSION 5.03 (K021072) | American Medical Resources, Ltd. (Amr) | 2002-06-06 |
| MICROSTREP PLUS PANEL, AZITHROMYCIN (K021169) | Dade Microscan, Inc. | 2002-06-06 |
| OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES (K011866) | Hyperbaric Technologies, Inc. | 2002-06-06 |
| DCM 2.0 (K020971) | Mds Nordion AB | 2002-06-06 |
| MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE (K021110) | Dade Microscan, Inc. | 2002-06-06 |
| VALVED PEELABLE INTRODUCER (K021004) | Medamicus, Inc. | 2002-06-06 |
| ARTHROCARE CONTROLLER, AUTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDS (K021519) | Arthrocare Corp. | 2002-06-06 |
| MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE (K021010) | Endocare, Inc. | 2002-06-06 |
| MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME (K021188) | Dade Microscan, Inc. | 2002-06-06 |
| MODEL 1133 IVD PC VERSION (K021463) | Sun Nuclear Corp. | 2002-06-06 |
| POWDER-FREE-VINYL EXAMINATION GLOVES, COLOR: WHITE (K021353) | Glormed Intl., Inc. | 2002-06-06 |
| FIXED BEARING UNI COMPONENT (K021621) | Biomet, Inc. | 2002-06-05 |
| ENDOSCOPIC LIGHT SOURCE XL202/L3 (K020889) | World of Medicine Lemke GmbH | 2002-06-05 |
| REDUCED SIZE ONCOLOGY SALVAGE SYSTEM (K021260) | Biomet, Inc. | 2002-06-05 |
| OMEGA II SYSTEM (K020772) | Howmedica Osteonics Corp. | 2002-06-05 |
| U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000 (K013902) | U-Systems, Inc. | 2002-06-05 |
| VACURECT VACUUM CONSTRICTION DEVICE (K020969) | Vacurect Manufacturing (Pty) , Ltd. | 2002-06-05 |
| REPLACE SCALLOPED MARGIN IMPLANT SYSTEM (K021584) | Nobel Biocare Uas, Inc. | 2002-06-05 |
| PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS (K020779) | Ethicon Endo-Surgery, Inc. | 2002-06-05 |
| PHYSICIAN'S DESKTOP REVIEW (K021669) | Adac Laboratories | 2002-06-05 |
| PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER (K013654) | Precision Systems, Inc. | 2002-06-05 |
| ASCENT ALL-POLY PS TIBIAL BEARINGS (K021559) | Biomet, Inc. | 2002-06-05 |
| PHYSIOLOG, SERIES 95000 (K013032) | Camtronics, Ltd. | 2002-06-04 |
| HYPERION VISIQUANT ANA TEST KIT (K013213) | Hyperion, Inc. | 2002-06-04 |
| CARESIDE ALT (K020487) | Careside, Inc. | 2002-06-04 |
| ANIMUS EZSERTER INFUSION SET INSERTER (K021700) | Animas Corp. | 2002-06-04 |
| UNICONDYLAR KNEE (K020741) | Encore Orthopedics, Inc. | 2002-06-04 |
| PARACON II/FECAL CONCENTRATOR II (K021420) | Para Scientific Co. | 2002-06-04 |
| IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IGEL 55 UV MULTIFOCAL (METHAFILCON A) SOFT (K020855) | Igel Vision Care Pte , Ltd. | 2002-06-04 |
| AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT) (K020395) | Lin-Zhi International, Inc. | 2002-06-04 |
| SILICONE TRACHEAL T-TUBES (K013321) | Technical Products, Inc. | 2002-06-04 |
| KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4 (K010132) | SOADCO, S.L. | 2002-06-04 |
| SAVIEW TORIC 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR (K021295) | St. shine Optical Co., Ltd. | 2002-06-04 |
| NLITE SYSTEM,MODEL A00-1051 (K020729) | Icn Photonics , Ltd. | 2002-06-04 |
| BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS (K020389) | Ocular Sciences | 2002-06-04 |
| PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS (K020364) | Phoenix Diagnostics, Inc. | 2002-06-04 |
| OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT); CATALOG # 0021 (5000 TESTS KIT) (K020368) | Lin-Zhi International, Inc. | 2002-06-04 |
| BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR (K020739) | Bci, Inc. | 2002-06-03 |
| TRAATEK COTTONOID PATTIES (K020736) | Traatek, Inc. | 2002-06-03 |
| FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE I, II AND FUTURE MODELS (K014040) | Altus Medical, Inc. | 2002-06-03 |
| MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS (K020776) | Coronet Group North America, LLC | 2002-06-03 |
| CHARE CARIOVASCULAR PATCH (K021129) | Chase Medical, Inc. | 2002-06-03 |
| NAVIPRO (K020764) | Kinamed, Inc. | 2002-06-03 |
| MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM (K021448) | Roche Diagnostics Corp. | 2002-06-03 |
| REPROCESSED ARTHROSCOPIC SHAPERS (K012667) | Surgical Instruments Service and Savings, Inc. | 2002-06-03 |
| MICROSCAN MICROSTREP PLUS PANEL-MEROPENEM (K020938) | Dade Microscan, Inc. | 2002-06-03 |
| ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) (K021257) | Diagnostic Products Corp. | 2002-06-03 |
| SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET (K013733) | Chf Solutions, Inc. | 2002-06-03 |
| SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE (K020718) | Precision Dynamics Corp. | 2002-06-03 |
| WALLACH LOOP ELECTRODE (K020711) | Wallach Surgical Devices, Inc. | 2002-06-03 |
| SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117 (K020821) | Biotronik, Inc. | 2002-06-03 |
| TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002 (K014247) | Biosite Incorporated | 2002-06-03 |
| ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100 (K021032) | Scantibodies Laboratory, Inc. | 2002-06-03 |
| DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEM (K020900) | Sunrise Medical Hhg, Inc. | 2002-06-03 |
| RPI REPLACEMENT PHOTOTHERAPY LIGHTS (K021531) | Replacement Parts Industries, Inc. | 2002-05-31 |
| AXSYM INTACT PTH, MODEL 2G06 (K020945) | Diagnostic Systems Laboratories, Inc. | 2002-05-31 |
| ENTERYX INJECTOR (K013712) | Enteric Medical Technologies | 2002-05-31 |
| INPATH E2 COLLECTOR (K013258) | Molecular Diagnostics | 2002-05-31 |
| INTRACOIL SELF-EXPANDING PERIPHERAL STENT (K021563) | Sulzer Intratherapeutics, Inc. | 2002-05-31 |
| RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION (K020802) | Bausch & Lomb, Incorporated | 2002-05-31 |
| EN-SNARE ENDOVASCULAR SNARE AND CATHETER (K021606) | Medical Device Technologies, Inc. | 2002-05-31 |
| SHANGHAI GLOVMAX ENTERPRISE POWDERED BLUE NITRILE EXAMINATION GLOVES (K021000) | Shanghai Glovmax Enterprise Co.,Ltd | 2002-05-31 |
| HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED FEMORAL STEM (K021403) | Biomet Orthopedics, Inc. | 2002-05-31 |
| MAXISTAT PVA FOAM EMBOLIZATION PARTICLES (K020033) | Surgica Corp. | 2002-05-31 |
| SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06 (K021379) | Ortho Tec, LLC | 2002-05-31 |
| SONOSITE HAND-CARIED UNTRASOUND SYSTEM (POWERSERIES) (K021628) | Sonosite,Inc. | 2002-05-31 |
| MODIFICATION TO ENTEC PLASMA WANDS (K021364) | Arthrocare Corp. | 2002-05-30 |
| DIGITAL CLINICAL THERMOMETER, MODELS ACT 2030, 2038 (K021612) | Actherm, Inc. | 2002-05-30 |
| ROSE K POST GRAFT LENS (K013646) | Rose K International , Ltd. | 2002-05-30 |
| TOESCO AQUA BLUE LED LIGHT CURING DEVICE (K021374) | Toei Electric Co., Ltd. | 2002-05-30 |
| ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A (K021587) | Medtronic Vascular | 2002-05-30 |
| DIGITAL CLINICAL THERMOMETER, MODEL ACT 3020 (K021614) | Actherm, Inc. | 2002-05-30 |
| LIGHTLANCE LASER SKIN PERFORATOR (K013021) | Innotech USA, Inc. | 2002-05-30 |
| ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218 (K021589) | Medtronic Vascular | 2002-05-30 |
| SS MATRIX (K020732) | Cook Biotech, Inc. | 2002-05-30 |
| WAVE FORM MANUFACTURING PROLASE GENERAL SHAPED FIBER (K020673) | Wave Form Mfg., Inc. | 2002-05-30 |
| SURX RF SYSTEM (K020952) | Surx, Inc. | 2002-05-30 |
| IMMULITE 2000 SPECIFIC ALLERGENS (K021206) | Diagnostic Products Corp. | 2002-05-30 |
| IMMULITE 2000 MIXED ALLERGEN PANELS (K021208) | Diagnostic Products Corp. | 2002-05-30 |
| MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO (K021439) | Animas Corp. | 2002-05-29 |
| MODIFICATION TO EN-BLOC BIOPSY SYSTEM (K021577) | Neothermia Corp. | 2002-05-29 |
| LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 467 (K021414) | Bio-Rad | 2002-05-29 |
| MICRO-INDUCTION 1000 SYSTEM (K013615) | Harbinger Medical, Inc. | 2002-05-29 |
| LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463 (K021411) | Bio-Rad | 2002-05-29 |