| SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN (K983249) | Euromed, Inc. | 1998-11-25 |
| HOFFMANN II MIAMI POST (K983419) | Howmedica Corp. | 1998-11-25 |
| ABBOTT ARCHITECT TOTAL T4 (K983440) | Abbott Laboratories | 1998-11-25 |
| ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500 (K982104) | Medical Data Electronics | 1998-11-25 |
| ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-05 (K984070) | Bio-Rad | 1998-11-25 |
| ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003 (K981802) | Bio-Detek, Inc. | 1998-11-25 |
| TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING (K983234) | Johnson & Johnson Medical, Div. of Ethicon, Inc. | 1998-11-25 |
| DEPUY LUSTER STEM (K983136) | DePuy Orthopaedics, Inc. | 1998-11-25 |
| SWEEN WOUN'DRES (K983042) | Coloplast Corp. | 1998-11-25 |
| IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5 (K983970) | Diagnostic Products Corp. | 1998-11-25 |
| PLUS BIPOLAR PROSTHESIS COCRMO (K982447) | Plus Orthopedics | 1998-11-25 |
| DCI ENDOSCOPE (K983384) | KARL STORZ Endoscopy-America, Inc. | 1998-11-25 |
| AARON COOLPAD SPLIT W/O CORD,AARON COOLPAD SPLIT WITH CORD, AARON COOLPAD W/O CORD, ARRON COOLPAD WITH CORD, MODELS ESRE (K983788) | Aaron Medical Industries | 1998-11-25 |
| COMPLETE BRAND LUBRICATING AND REWETTING DROPS (K983150) | Allergan, Inc. | 1998-11-25 |
| EA-D IGM ELISA TEST SYSTEM (K982350) | Columbia Bioscience, Inc. | 1998-11-25 |
| SYSTEM U3 FOR TRIMETHOPRIM/SULFAMETHOXAZOLE (K983259) | Ab Biodisk | 1998-11-25 |
| AMIELLE (K983045) | Owen Mumford USA, Inc. | 1998-11-25 |
| ACUTRON MENTOR MODEL 961 (K981976) | Microcurrent Research, Inc. | 1998-11-25 |
| SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN (K983301) | Accumed Intl., Inc. | 1998-11-25 |
| COMPACT KTP LASER (K983020) | Cosmos Medical Technology | 1998-11-25 |
| OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AN NON-SIGHTED EYES) (K983278) | Alden Optical Labs., Inc. | 1998-11-25 |
| MODIFICATION TO BIO-LOGIC SLEEPSCAN (K983913) | Bio-Logic Systems Corp. | 1998-11-25 |
| PRECISET SERUM PROTEINS CALIBRATOR (K983469) | Boehringer Mannheim Corp. | 1998-11-25 |
| CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI (K983004) | Hayes Medical, Inc. | 1998-11-25 |
| SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEM (K982322) | Synthes (Usa) | 1998-11-25 |
| SPECTRUM SMALL FRY (K983859) | Freedom Designs, Inc. | 1998-11-25 |
| DORNIER MEDILA H (K983963) | Dornier Medtech America, Inc. | 1998-11-25 |
| ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-05 (K984073) | Bio-Rad | 1998-11-25 |
| BSM- BONE SUBSTITUTE MATERIAL (K983009) | Etex Corp. | 1998-11-25 |
| PNEUMATIC CUTTER SYSTEM (K983050) | Surgical Laser Technologies, Inc. | 1998-11-25 |
| MEDISYSTEMS TRANSDUCER PROTECTOR (K983076) | Medisystems Corp. | 1998-11-25 |
| GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL (K983726) | Genzyme Corp. | 1998-11-25 |
| MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS (K981365) | Sherwood Medical Co. | 1998-11-25 |
| BIOSTREP A-DIRECT STREP A ANTIGEN TEST (K983386) | Princeton BioMeditech Corp. | 1998-11-25 |
| PREMIER GIARDIA (K982711) | Meridian Diagnostics, Inc. | 1998-11-25 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT (K983895) | Beckman Coulter, Inc. | 1998-11-25 |
| MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY (K982027) | DiaSorin, Inc. | 1998-11-25 |
| EBNA-1 IGM ELISA TEST SYSTEM (K982348) | Columbia Bioscience, Inc. | 1998-11-25 |
| SOLO-CARE BRAND MULTI-PURPOSE SOLUTION (K983291) | Ciba Vision Corporation | 1998-11-25 |
| CRYOPRO MAXI AND CRYOPRO MINI (K982280) | Cortex Technology Aps | 1998-11-25 |
| AB FLU OIA (K981651) | Biostar, Inc. | 1998-11-25 |
| VCA IGM ELISA TEST SYSTEM (K982352) | Columbia Bioscience, Inc. | 1998-11-25 |
| PERIPHERAL AVE STENT SYSTEM (K983008) | Peripheral Ave | 1998-11-25 |
| ARTHRO-SURGIMAT-1500 (K983910) | W.O.M. World of Medicine GmbH | 1998-11-25 |
| ARCHITECT TSH MASTERCHECK, LIST NO, 6C52-05 (K984072) | Bio-Rad | 1998-11-24 |
| DISTAFLO BYPASS GRAFT (K983861) | Impra, Inc. | 1998-11-24 |
| PERFUSION CT (COMPUTED TOMOGRAPHY) SOFTWARE PACKAGE (K982536) | Siemens Corp. | 1998-11-24 |
| ERCO-RIBBON (K981343) | Ercons, Inc. | 1998-11-24 |
| ULTRASOUND WORKSTATION, UIWS-300A (K982976) | Toshiba America Medical Systems, In.C | 1998-11-24 |
| MICROMEDICS NASAL SEPTAL BUTTON (K982667) | Micromedics, Inc. | 1998-11-24 |
| TUBING BLOOD FLOW METER MODEL NUMBER HD-800 (K982986) | Koven Technology, Inc. | 1998-11-24 |
| PHILIPS BUCKY VISION (K982795) | Philips Medical Systems, Inc. | 1998-11-24 |
| INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN (K983819) | Intervascular, Inc. | 1998-11-24 |
| SHUN-THAI - SAFE-CONTACT, BOSTON MEDICAL LATEX EXAM GLOVE, SHUN-THAI LATEX EXMINATION GLOVE (K982416) | Shun Thai Rubber Gloves Industry Co., Ltd. | 1998-11-24 |
| BAXTER HEMOSTASIS VALVE INTRODUCERS (K981909) | Baxter Edwards | 1998-11-24 |
| FLOWMATE II PLUS, MODEL #4000 (K982956) | Spirometrics Medical Equipment Co. | 1998-11-24 |
| IN-PROBE II URODYNAMIC SYSTEM (K983325) | Influence, Inc. | 1998-11-24 |
| ERCO-VAC (K981357) | Ercons, Inc. | 1998-11-24 |
| ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES (K982965) | Richard Wolf Medical Instruments Corp. | 1998-11-23 |
| CUSTOM FLANGED ACETABULAR COMPONENT (K983035) | Biomet, Inc. | 1998-11-23 |
| OSTEO 5.0MM CANNULATED SCREW SYSTEM (K983006) | Stryker Osteonics | 1998-11-23 |
| SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT 80/140, TOB 6 WASHER MODELS 12MM 16MM 1M (K982354) | Special Devices, Inc. | 1998-11-23 |
| V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) (K983916) | Hdc Corp. | 1998-11-23 |
| ORATEC TAC-C, MONOPOLAR CAUTERY PROBE (K982971) | Oratec Interventions, Inc. | 1998-11-23 |
| M1145 (UPS1-1.25K-1G-MP) UPS (K981412) | Clary Corp. | 1998-11-23 |
| SPECTRUM SPIRIT (K983763) | Freedom Designs, Inc. | 1998-11-23 |
| AURORA (K981379) | Premier Laser Systems, Inc. | 1998-11-23 |
| METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC 21-D (K981249) | Instrumentation Industries, Inc. | 1998-11-23 |
| MODEL 340GE-21C QUADRATURE BRAIN COIL (K982978) | Medical Advances, Inc. | 1998-11-23 |
| MITEK FASTIN RC ANCHOR (K983818) | Mitek Products | 1998-11-23 |
| BPOS-IVAD STABILIZER (K983480) | Bpos, Inc. | 1998-11-23 |
| QUADRANT ANTERIOR SHINE (K983549) | Cavex Holland BV | 1998-11-23 |
| STEALTHSTATION TREATMENT GUIDANCE PLATFORM (K981768) | Surgical Navigation Technologies, Inc. | 1998-11-23 |
| AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U (K982759) | OraSure Technologies, Inc. | 1998-11-20 |
| PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT (K983253) | Medisense, Inc. | 1998-11-20 |
| BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE (K983981) | Bear Medical Systems, Inc. | 1998-11-20 |
| NASAL DORSAL SERIES (K983755) | Surgical Technology Laboratories, Inc. | 1998-11-20 |
| STANDARD CHIN (K983754) | Surgical Technology Laboratories, Inc. | 1998-11-20 |
| SURGIFORM ANATOMICAL MALAR (K983756) | Surgical Technology Laboratories, Inc. | 1998-11-20 |
| ARCHITECT TOTAL T4 MASTERCHECK, LIST NO. 6C49-05 (K984074) | Bio-Rad | 1998-11-20 |
| ABBOTT ARCHITECT TSH (K983442) | Abbott Laboratories | 1998-11-20 |
| PERIFORM (K981277) | Verimed Holdings, Inc. | 1998-11-20 |
| NEUROMAP (K981820) | Radionics, Inc. | 1998-11-20 |
| SYSTEM U3 FOR GENTAMICIN (K983252) | Ab Biodisk North America, Inc. | 1998-11-20 |
| ABBOTT ARCHITECT FREE T3 (K983439) | Abbott Laboratories | 1998-11-20 |
| ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP (K983838) | Abbott Laboratories | 1998-11-20 |
| POLYMER THREADED ANCHOR / SUTURE COMBINATION (K982963) | Orthopaedic Biosystems, Ltd. | 1998-11-20 |
| ABBOTT ARCHITECT TOTAL T3 (K983434) | Abbott Laboratories | 1998-11-20 |
| ZETA MULTIZONE LOCKING NAIL SYSTEM (K982958) | Howmedica Corp. | 1998-11-20 |
| LATEX PATIENT EXAMINATION GLOVE POWDERFREE (BLUE COLOR) POLYMER COATED (K981975) | Siam Sempermed Corp., Ltd. | 1998-11-20 |
| ABBOTT ARCHITECT FREE T4 (K983417) | Abbott Laboratories | 1998-11-20 |
| URESIL VASCU-FLO INFUSION CATHETER (K980278) | Uresil Corp. | 1998-11-20 |
| SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM (K981530) | Spacelabs Medical, Inc. | 1998-11-20 |
| MODIFICATION TO PORTABLE INTENSIVE CARE UNIT (K983307) | Medical Research Laboratories, Inc. | 1998-11-20 |
| STERI-PAK BOWIE DICK TEST PACK (K982188) | Steritec Products Mfg Co, Inc. | 1998-11-20 |
| MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER (K982937) | Victoreen, Inc. | 1998-11-19 |
| HEM-O-LOCK, MODEL 523935 (K982944) | Weck Closure Systems | 1998-11-19 |
| ASTRA TECH IMPLANT DENTAL SYSTEM (K974738) | Astra Tech, Inc. | 1998-11-19 |
| CANOGEN PORTABLE OXYGEN GENERATOR MODEL 615 (K982243) | Canogen International , Ltd. | 1998-11-19 |
| IMPRA HIGH POROSITY GRAFT (K983064) | Impra, Inc. | 1998-11-19 |