| WARTNER WART REMOVAL SYSTEM (K002714) | Wartner Medical Products | 2000-11-28 |
| DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM (K003473) | Elscintec Systems , Ltd. | 2000-11-28 |
| COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL (K002064) | Wrp Asia Pacific Sdn. Bhd. | 2000-11-28 |
| SELF ETCH BONDING PRIMER (K003011) | Jeneric/Pentron, Inc. | 2000-11-28 |
| RENEW LS-2 (K003361) | Bisco, Inc. | 2000-11-28 |
| ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM (K003069) | Quest Intl., Inc. | 2000-11-27 |
| SOFTSENS (K001521) | Integrated Biosensing Technologies | 2000-11-27 |
| VARELISA TG (THYROGLOBULIN) ANTIBODIES, (K003414) | Pharmacia & Upjohn Co. | 2000-11-27 |
| BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST (K002268) | Branan Medical Corporation | 2000-11-27 |
| BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST (K002263) | Branan Medical Corp. | 2000-11-27 |
| BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST (K002264) | Branan Medical Corporation | 2000-11-27 |
| BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST (K002342) | Branan Medical Corporation | 2000-11-27 |
| COLOSCREEN-ES (K003359) | Helena Laboratories | 2000-11-27 |
| BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCREEN TEST (K002265) | Branan Medical Corporation | 2000-11-27 |
| SYNCHRON CONTROL (K003488) | Beckman Coulter, Inc. | 2000-11-27 |
| ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30 (K003093) | Diagnostic Chemicals , Ltd. | 2000-11-27 |
| N/T PROTEIN CONTROL SL (K002852) | Dade Behring, Inc. | 2000-11-27 |
| COD COMPRESSION OSTEOTOMY DEVICE (K002184) | Walter Abendschein, M.D. | 2000-11-24 |
| LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE (K002765) | Integra Neurosciences | 2000-11-24 |
| SCAN LT40 (40 CHANNELS) (K001564) | Neuro Scan Labs | 2000-11-24 |
| HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR (K002764) | Hydrocision, Inc. | 2000-11-24 |
| ISS OFFSET HEADS (K003428) | Biomet, Inc. | 2000-11-24 |
| DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM (K000651) | Cook, Inc. | 2000-11-24 |
| ONCOLOGY SALVAGE SYSTEM (K002757) | Biomet, Inc. | 2000-11-24 |
| SALUMEDICA NERVE CUFF (K002098) | Salumedica, LLC | 2000-11-24 |
| METRX SYSTEM (K002931) | Medtronic Sofamor Danek, Inc. | 2000-11-24 |
| VERSALINK TITANIUM ROD-TO-ROD COUPLERS (K003384) | Osteotech, Inc. | 2000-11-24 |
| CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC (K003028) | Osteogenics Biomedical, Inc. | 2000-11-24 |
| NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8 (K001692) | Neurosoft, Inc. | 2000-11-24 |
| IMAGE VASCULAR LASER (K003046) | Sciton, Inc | 2000-11-24 |
| ALUMINA V40 HEAD (K003413) | Howmedica Osteonics Corp. | 2000-11-24 |
| IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) (K002886) | Implantech Associates, Inc. | 2000-11-24 |
| GIMBEL PUNCTURE RESISTANT LATEX SURGICAL GLOVE WITH PUNCTURE RESISTANCE FINGERTIP PROTECTION (K003063) | Gimbel Glove Co., LLC | 2000-11-22 |
| IM-5B MICROINJECTOR (K003303) | Narishige Co., Ltd. | 2000-11-22 |
| BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST (K002337) | Branan Medical Corporation | 2000-11-22 |
| MO-202D THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANIPATOR (K003300) | Narishige Co., Ltd. | 2000-11-22 |
| PC ECG 1200 (K000404) | Norav Medical , Ltd. | 2000-11-22 |
| COMFIT CHEMO PLUS PLUS POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) (K001613) | Wrp Asia Pacific Sdn. Bhd. | 2000-11-22 |
| MEDLINE ALOE TOUCH STERILE NITRILE EXAMINATION GLOVES WITH ALOE VERA (K003353) | Medline Industries, Inc. | 2000-11-22 |
| MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K003336) | Cordis Corp. | 2000-11-22 |
| BIO-RAD %CDT TIA (K001651) | Axis-Shield Biochemicals, Asa | 2000-11-22 |
| C. DIFFICILE TOX A/B II (K003306) | Techlab, Inc. | 2000-11-22 |
| ALPHA OMEGA DUAL COOLER-HEATER (K001520) | Alpha Omega, Inc. | 2000-11-22 |
| SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET (K001563) | Scion Cardiovascular, Inc. | 2000-11-22 |
| PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA (K002024) | Panbio, Inc. | 2000-11-22 |
| BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST (K002266) | Branan Medical Corporation | 2000-11-22 |
| VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES, YELLOW (K003197) | Kaohsiung Brothers Products Corp. | 2000-11-22 |
| IM-5A INJECTOR (K003302) | Narishige Co., Ltd. | 2000-11-22 |
| WMT ULTRA-FIT MODULAR SHOULDER SYSTEM (K002683) | Wrightmedicaltechnologyinc | 2000-11-22 |
| BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160D (K002272) | Branan Medical Corp. | 2000-11-22 |
| DERMAGRIP POWDER FREE PINK POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERILE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL W (K003307) | Wrp Specialty Products Sdn. Bhd. | 2000-11-22 |
| BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, MODEL 190C AND 190D (K002417) | Branan Medical Corporation | 2000-11-22 |
| VOLUSON 730 DIAGNOSTIC ULTRASOUND SYSTEM (K003525) | Medison America, Inc. | 2000-11-22 |
| BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG SCREEN TEST (K002587) | Branan Medical Corporation | 2000-11-22 |
| TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV (K002816) | Transonic Systems, Inc. | 2000-11-22 |
| S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS) (K003365) | Cordis Corp. | 2000-11-22 |
| DERMAGRIP POWDER FREE GREEN POLYMER COATED EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE (K003309) | Wrp Specialty Products Sdn. Bhd. | 2000-11-22 |
| <GENX> CODA INCUBATOR CELLMATE (K001600) | <Genx> Intl., Inc. | 2000-11-22 |
| ENTERIC INJECTION CATHETER WITH IRRIGATION (K002778) | Enteric Medical Technologies, Inc. | 2000-11-22 |
| EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING (K002598) | J. H. Emerson Co. | 2000-11-22 |
| DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT2B27(CARDIOLOGY), PT3B27(CLASSIC), PT5B2 (K002047) | Doctor'S Research Group, Inc. | 2000-11-22 |
| T.I.M.S., VERSION 2.00 (K001947) | Total Medical Information Management Systems, Inc. | 2000-11-22 |
| IM-6 MICROINJECTOR (K003304) | Narishige Co., Ltd. | 2000-11-22 |
| MICROMANIPULATOR (K003142) | Research Instruments , Ltd. | 2000-11-22 |
| JAMSHIDI MARROW ACQUISITION CRADLE (K003370) | Allegiance Healthcare Corp. | 2000-11-22 |
| VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH (K002672) | ETHICON, Inc. | 2000-11-22 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR (K003321) | Shanghai Antares Industries, Inc. | 2000-11-22 |
| MODEL 6900GE-64: C-SPINE ARRAY (K002860) | Midwest Rf, LLC | 2000-11-22 |
| BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D (K002418) | Branan Medical Corporation | 2000-11-22 |
| MINITUB MULTI-PURPOSE CASSETTES (K002961) | Zander Medical Supplies, Inc. | 2000-11-21 |
| K-DEFIB/PACE, MODEL KDP-60A (K002806) | Katecho, Inc. | 2000-11-21 |
| MODEL WS-500 DIGITAL WRIST BLOOD PRESSURE MONITOR (K003444) | Nihon Seimitsu Sokki Co., Ltd. | 2000-11-21 |
| SINUSCOPE AND BACCESSORIES (K002214) | Pollux Endoscopy, Inc. | 2000-11-21 |
| MO-202U THREE-AXIS JOYSTICK HYDRAULIC MICROMANIPULATOR (K003298) | Narishige Co., Ltd. | 2000-11-21 |
| ARAMIS DERMATOLOGICAL LASER (K002649) | Palomar Medical Technologies, Inc. | 2000-11-21 |
| O-PERM 30 (K002703) | Optical Polymer Research, Inc. | 2000-11-21 |
| MICROPAQ, MODELS 402 AND 404 (K002725) | Protocol Systems, Inc. | 2000-11-21 |
| PINNACLE R/O II OR RADIFOCUS INTRODUCER II (K003424) | Terumo Medical Corp. | 2000-11-21 |
| ROSETTA-LT/ROSETTA-RX (K002089) | General Devices | 2000-11-21 |
| PURESPERM WASH (K002630) | Nidacon International AB | 2000-11-21 |
| NIPRO SAFETOUCH SAFETY FISTULA NEEDLE (K002813) | Nipro Medical Corp. | 2000-11-21 |
| COMPLETE BRAND LUBRICATING AND REWETTING DROPS (K003109) | Allergan, Inc. | 2000-11-21 |
| MODEL 6600GE-64: TRAMA NECK ARRAY (K002864) | Midwest Rf, LLC | 2000-11-21 |
| SPECIALTY TINT SOFT CONTACT LENS (K003079) | Specialty Tint | 2000-11-21 |
| RENEW LS-1 (K003317) | Bisco, Inc. | 2000-11-21 |
| CLINIFLO INCENTIVE SPIROMETER (K003146) | Dhd Healthcare Corp. | 2000-11-21 |
| SILMAX PECTORAL IMPLANT (K002633) | Pillar Surgical, Inc. | 2000-11-21 |
| MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET (K002199) | Pointe Scientific, Inc., | 2000-11-20 |
| SILMAX CONTOUR CARVING BLOCK IMPLANT (K002629) | Pillar Surgical, Inc. | 2000-11-20 |
| PURESPERM 40 AND PURESPERM 80 (K002623) | Nidacon International AB | 2000-11-20 |
| RADIAL HEAD IMPLANT (K002644) | Avanta Orthopaedics, Inc. | 2000-11-20 |
| RS BIOTECH GALAXY 'R' CO2 INCUBATOR (K003184) | Zander Medical Supplies, Inc. | 2000-11-20 |
| TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST (DEN000010) | Biosite Incorporated | 2000-11-20 |
| 4.0/2.5 MM SELF-DRILLING SCHANZ SCREW (K002605) | Synthes (Usa) | 2000-11-20 |
| MAGNA TEK ESU-400 (K003471) | Huttinger Medizintechnik GmbH & CO KG | 2000-11-20 |
| ACCESS ULTRASENSITIVE HGH CALIBRATORS (K003098) | Beckman Coulter, Inc. | 2000-11-20 |
| N LATEX B2-MICROGLOBULIN (K002731) | Dade Behring, Inc. | 2000-11-20 |
| BAYONET FORCEPS BIPOLAR IRRIGATING (K002752) | Q2 Medical | 2000-11-20 |
| MEDPOR PTERIONAL SURGICAL IMPLANT (K002586) | Porex Surgical Products Group | 2000-11-17 |
| RACE ENDODONTIC FILE (K002709) | Amc General, Inc. | 2000-11-17 |