| PRESSURE WIRE SENSOR, MODEL 12003/12303 (K002962) | Radi Medical Systems AB | 2000-10-04 |
| EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL (K002484) | Electro Medical Systems SA | 2000-10-04 |
| INQWIRE DIAGNOSTIC GUIDE WIRE (K002289) | Merit Medical Systems, Inc. | 2000-10-04 |
| VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192 (K001460) | bioMerieux, Inc. | 2000-10-04 |
| ASCENT XXL CLOSED BOX FEMORAL COMPONENT (K002772) | Biomet, Inc. | 2000-10-04 |
| AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES (K002074) | H&C Medical Devices Spa | 2000-10-04 |
| GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING (K001125) | Geuder GmbH | 2000-10-04 |
| PERCLOSE VASCULAR SUTURE DELIVERY DEVICE (K001703) | Abbott Vascular, Inc. | 2000-10-03 |
| INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER (K002490) | Fonar Corp. | 2000-10-03 |
| POLYMER COAT, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K002568) | Smart Glove Corp. Sdn Bhd | 2000-10-03 |
| MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE (K002836) | Sage Biopharma | 2000-10-03 |
| BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID (K002213) | Hunter Research Laboratories, Inc. | 2000-10-03 |
| ENDIUS ENDOSCOPIC ACCESS SYSTEM (K002437) | Endius, Inc. | 2000-10-02 |
| BETA GLUCAN GEL (MACROPRO GEL) (K002078) | Brennen Medical, Inc. | 2000-10-02 |
| GLUCANPRO CREAM (K002077) | Brennen Medical, Inc. | 2000-10-02 |
| BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 (K002294) | Biocheck, Inc. | 2000-10-02 |
| STRYKER NAVIGATION SYSTEM - ENT MODULE (K002732) | Stryker Corp. | 2000-10-02 |
| TORNIER TOTAL ELBOW PROSTHESIS (K000003) | Tornier | 2000-10-02 |
| DISPOSABLE H-PE MICROKERATOME BLADES (K001464) | Oasis | 2000-10-02 |
| CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15 (K002296) | Ceram Optec, Inc. | 2000-10-02 |
| OLYMPIC WARM-UP (K001056) | Olympic Medical Corp. | 2000-09-29 |
| MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA) (K994112) | Oncogene Science, Inc. | 2000-09-29 |
| BRAVO PH MONITORING SYSTEM (K002028) | Endonetics, Inc. | 2000-09-29 |
| OMNIPORT (K002013) | Advanced Surgical Concepts (Asc) | 2000-09-29 |
| BIOSYS FETAL MONITOR, MODEL IFM-500 (K994008) | Biosys Co. , Ltd. | 2000-09-29 |
| MODIFICATION TO: PRONTO DRY (K002451) | Medical Instruments Corporation, AG | 2000-09-29 |
| MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS (LINE EXTENSION) (K002710) | Synthes (Usa) | 2000-09-29 |
| BAYER IMMUNO 1 HER-2/NEU ASSAY (K992228) | Bayer Corp. | 2000-09-29 |
| MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER (K002833) | Standard Imaging, Inc. | 2000-09-28 |
| MEDLINK DIAGNOSTIC OFFLINE WORKSTATION (K002144) | Advanced Technology Laboratories, Inc. | 2000-09-28 |
| MODIFICATION TO PROVIDENT HIP SYSTEM (K002796) | Stelkast Company | 2000-09-28 |
| 3M RELY X VENEER CEMENT TRY-IN PASTER (K002452) | 3M Company | 2000-09-28 |
| REBAR MICRO CATHETER: REBAR-10 (1.7F), 153 CM, DUAL MARKER BANDS; REBAR MICRO CATHETER: REBAR-10 (1.7F), 170 CM, DUAL MA (K002723) | Micro Therapeutics, Inc. | 2000-09-28 |
| COMFORT CONTROL SYRINGE SYSTEM (K002387) | Dentsply Intl. | 2000-09-28 |
| AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA (K002215) | Cogent Diagnotics , Ltd. | 2000-09-28 |
| PREFERENCE TREATMENT SYSTEM (K001833) | Northwest Medical Physics Equipment, Inc. | 2000-09-28 |
| MODIFICATION TO PROFILE -II (K002776) | Medtox Diagnostics, Inc. | 2000-09-28 |
| HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND HOLOGIC DELPHI X-RAY BONE DENSITOMETER (K002711) | Hologic, Inc. | 2000-09-28 |
| MODIFICATION TO CD HORIZON SPINAL SYSTEM (K002399) | Medtronic Sofamor Danek, Inc. | 2000-09-27 |
| ECAT PET SCANNER, MODELS ECAT EXACT AND ECAT EXACT HR+ AND ECAT ART (K002039) | Cti Pet Systems, Inc. | 2000-09-27 |
| SURGITRON IEC II (K001986) | Ellman Intl., Inc. | 2000-09-27 |
| KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY (K002146) | Eastman Kodak Company | 2000-09-27 |
| ORALUBE (K000847) | Orasystems | 2000-09-27 |
| TYSHAK, MODEL 102 AND Z-MED, MODEL 302 (K991977) | NuMED, Inc. | 2000-09-27 |
| PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT (K001984) | Stelkast Company | 2000-09-27 |
| WIRE, GUIDE, CATHETER, MODEL QSW1000 (K002346) | Medtronic Ave, Inc. | 2000-09-27 |
| COMPRESSAR FEMORAL ACCESS COMPRESSION DEVICE (K002767) | Semler Technologies, Inc. | 2000-09-27 |
| ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110 (K001980) | Aspect Medical Systems, Inc. | 2000-09-27 |
| SUPER 14 (K002302) | Dental Alloy Products, Inc. | 2000-09-26 |
| KETAC CEM U (K002793) | Espe Dental AG | 2000-09-26 |
| IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10 (K002770) | Hdc Corp. | 2000-09-26 |
| CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80 (K002354) | Diagnostic Chemicals , Ltd. | 2000-09-26 |
| OLYMPUS SONOSURG TROCAR XT3900 SYSTEM (K000095) | The Olympus Optical Co. | 2000-09-26 |
| BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D (K001244) | Citizen Watch Co., Ltd. | 2000-09-26 |
| ATAC PAK ALP REAGENT KIT (K002285) | Elan Diagnostics | 2000-09-26 |
| FREEZER TEETHER (K002066) | Cool Baby, Inc. | 2000-09-26 |
| DRX HBA1C - FOR PRESCRIPTION HOME USE (K000885) | Metrika, Inc. | 2000-09-26 |
| PROTEIN C REAGENT (K002541) | Dade Behring, Inc. | 2000-09-26 |
| OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010 (K000512) | Cas Medical Systems, Inc. | 2000-09-26 |
| CLOUD CUFF (K002360) | Parts Port, Ltd. | 2000-09-26 |
| OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES (K002030) | Invivo Research, Inc. | 2000-09-26 |
| HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT (K002461) | Shofu Dental Corp. | 2000-09-26 |
| SUPER 6 (K002300) | Dental Alloy Products, Inc. | 2000-09-26 |
| BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 (K001022) | Biocheck, Inc. | 2000-09-26 |
| BN PROSPEC SYSTEM (K001647) | Dade Behring, Inc. | 2000-09-26 |
| JET 1 POWERED WHEELCHAIR (K001970) | Pride Mobility Products Corp. | 2000-09-26 |
| CONSTELLATION CATHETERS (K000277) | Boston Scientific Corp | 2000-09-26 |
| LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578 (K002865) | Bio-Rad | 2000-09-25 |
| LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574 (K002866) | Bio-Rad | 2000-09-25 |
| PERIPHERALLY INSERTED CENTRAL CATHETER (K001874) | Utah Medical Products, Inc. | 2000-09-25 |
| LIPIDURE REWETTING DROPS (K000975) | Nof Corp. | 2000-09-25 |
| KEYSTONE MEDICAL SCHON XL SOFT-LINE DOUBLE LUMENT CATHETER. KEYSTONE MEDICAL 12 F DUO-FLOW AND 14F DUO-FLOW 400 XL CATH (K001958) | Keystone Medical | 2000-09-25 |
| PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE (K002414) | Fisher & Paykel Healthcare, Ltd. | 2000-09-25 |
| ILT 0.014 CATHETER, MODEL C114NL2 (K001992) | Intra Luminal Therapeutics, Inc. | 2000-09-25 |
| MMN-1 COARSE MANIPULATOR (K002653) | Narishige Co., Ltd. | 2000-09-22 |
| SYNTHES MODULAR FOOT SYSTEM (K001941) | Synthes (Usa) | 2000-09-22 |
| SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES (K001945) | Synthes (Usa) | 2000-09-22 |
| BOLUSPRO ULTRA (K002005) | Marconi Medical Systems, Inc. | 2000-09-22 |
| VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES (K001926) | Thoratec Laboratories Corp. | 2000-09-22 |
| MEDLINE ELECTRONIC POSITIONING CHAIR (K001937) | Medline Industries, Inc. | 2000-09-22 |
| MMO-202ND THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANPULATOR (K002659) | Narishige Co., Ltd. | 2000-09-22 |
| FREEDOM, MODEL 4660 (K001023) | Johnson & Johnson Consumer Companies, Inc. | 2000-09-22 |
| MMO-202N THREE-AXIS JOYSTICK OIL HYDRAULIC MICROMANIPULATOR (K002658) | Narishige Co., Ltd. | 2000-09-22 |
| HOWMEDICA OSTEONICS SHOULDER SCREW (K002654) | Howmedica Osteonics Corp. | 2000-09-22 |
| DISPOSABLE MICROKERATOME BLADES-PE (K001176) | Oasis Medical, Inc. | 2000-09-21 |
| ZOLL M SERIES NIBP OPTION, MODEL MSERIES NIBP OPTION (K002029) | Zoll Medical Corp | 2000-09-21 |
| DINAMAP PRO 1000 MONITOR, MODEL 1000 (K002248) | Critikon Company, LLC | 2000-09-21 |
| MODIFICATION TO ACRYDERM SILVER ANTIMICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045 (K002599) | Acrymed, Inc. | 2000-09-21 |
| 4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER (K000825) | Medi-Dyne, Inc. | 2000-09-21 |
| SOPHY SU8 PRESSURE ADJUSTABLE VALVE (K992465) | Sophysa SA | 2000-09-21 |
| ZYBIT (K002004) | Zymed Medical Instrumentation | 2000-09-21 |
| DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER (K002878) | Datex-Ohmeda, Inc. | 2000-09-21 |
| POLESTAR N-10 (K002242) | Odin Technologies , Ltd. | 2000-09-20 |
| CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ (K994340) | Hai Laboratories, Inc. | 2000-09-20 |
| ALOKA UST-5280-5 (K002784) | Aloka Co., Ltd. | 2000-09-20 |
| VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS (K000664) | Baxter Healthcare Corp | 2000-09-20 |
| MICOR CONDUCTION CATHETER (K001717) | Micor, Inc. | 2000-09-20 |
| BABY DOPPLEX 4002-TWINS, MODEL BD4002 (K001882) | Huntleigh Healthcare, Inc. | 2000-09-19 |
| ULTRASORB SUTURE ANCHOR (K002413) | Li Medical Technologies, Inc. | 2000-09-19 |
| CANDELA SPTL-1B PULSED DYE LASER (K001093) | Candela Corp. | 2000-09-19 |