| PALMLIGHT (K003383) | Ultradent Products, Inc. | 2001-02-06 |
| COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE (K003958) | Coalescent Surgical | 2001-02-06 |
| EXCITE DSC (K003293) | Ivoclar North America, Inc. | 2001-02-06 |
| TAI-CHI ACUPUNCTURE NEEDLES (K003760) | Lhasa Medical, Inc. | 2001-02-06 |
| MODULAR (K001988) | Heyer America, Inc. | 2001-02-05 |
| MICTEC ENDOSCOPES AND ACCESSORIES (K002877) | Dufner Instrumente GmbH | 2001-02-05 |
| MULTI INTERFERENTIAL STIMULATOR, MODEL TR-841 (K993600) | Nisha Communication Industries | 2001-02-05 |
| ADVIA 120 HEMATOLOGY (K003796) | Bayer Corp. | 2001-02-05 |
| PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602 (K002280) | Medical Devices, Inc. | 2001-02-05 |
| OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE) (K003704) | Optovent AB | 2001-02-05 |
| ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY (K010050) | Bayer Diagnostics Corp. | 2001-02-05 |
| INTRAVASCULAR ADMINISTRATION SET (K003854) | Infusion Devices, Inc. | 2001-02-05 |
| MINIQUANT D-DIMER, MODEL 1447 (K002642) | Biopool Intl., Inc. | 2001-02-05 |
| LIVESURE THC SCREEN TEST (K010001) | Pan Probe Biotech, Inc. | 2001-02-05 |
| RANDOX TRANSFERRIN (K002585) | Randox Laboratories, Ltd. | 2001-02-05 |
| ELECTROSTATIC HYDROPHOBIC BREATHING FILTER (K002201) | Sims Portex, Inc. | 2001-02-05 |
| ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS (K010081) | Exactech, Inc. | 2001-02-05 |
| IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2 (K003597) | Diagnostic Products Corp. | 2001-02-05 |
| TRIOLOGY ACETABULAR SYSTEM 46MM LARGE HEAD LINERS, MODEL 6310 (K003478) | Zimmer, Inc. | 2001-02-05 |
| CURRY MULTIMODAL NEUROIMAGING SOFTWARE (K001781) | Neurosoft, Inc. | 2001-02-05 |
| ANALGESIC PULSER, MODEL AP-439 (K993229) | Johari Electro-Tech Co. | 2001-02-02 |
| MODIFICATION TO ARTOSCAN M (K010057) | Biosound Esaote, Inc. | 2001-02-02 |
| NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8 (K003489) | Medical Illumination International, Inc. | 2001-02-02 |
| EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER (K002407) | Medica Corp. | 2001-02-02 |
| SURGI-VISION GUIDEWIRE COIL (K003436) | Surgi-Vision, Inc. | 2001-02-02 |
| WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE (K002219) | Wandy Rubber Industrial Co., Ltd. | 2001-02-02 |
| PHS-63 PEDIATRIC HEAD AND SPINE ARRAY COIL (K003655) | Mri Devices Corp. | 2001-02-02 |
| P3IMRT TM (K002237) | Adac Laboratories | 2001-02-02 |
| WANDY SILICONE CONDUCTIVE RUBBER PAD (K002227) | Wandy Rubber Industrial Co., Ltd. | 2001-02-02 |
| OPDIMA (K003945) | Siemens Medical Solutions USA, Inc. | 2001-02-02 |
| PORTALVISION (K003636) | Varian Medical Systems, Inc. | 2001-02-02 |
| SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS (K001965) | North American Medical Products, Inc. | 2001-02-02 |
| X-RAY SYSTEM XR-MX (K004037) | Karl Storz Endoscopy | 2001-02-02 |
| SELECT SEED I-125 (K002429) | Nucletron Corp. | 2001-02-02 |
| ODYSSEY LX, MODEL 211320 (K003437) | Philips Medical Systems (Cleveland), Inc. | 2001-02-02 |
| ACE SDS 3.75MM SCREW DENTAL IMPLANT (K002075) | Ace Surgical Supply Co., Inc. | 2001-02-02 |
| CLEAN SCRAPE (K003773) | Webb Research Ii, Inc. | 2001-02-02 |
| DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048; DYONICS AUTOCLAVABLE CAMERA COUPLER MODEL 7207905 (K003710) | Smith & Nephew, Inc. | 2001-02-02 |
| SUCTION IRRIGATOR (K003443) | Applied Medical | 2001-02-01 |
| EEG WITH VIDEO, MODEL EX-NW (K010091) | Excel Tech. , Ltd. | 2001-02-01 |
| BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE (K990284) | Baylis Medical Co., Inc. | 2001-02-01 |
| MODIFICATION TO CAVERMAP SURGICAL AID (K010098) | Uromed Corp. | 2001-02-01 |
| BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE (K003461) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2001-02-01 |
| M2376A DEVICELINK SYSTEM (K010048) | Agilent Technologies, Inc. | 2001-02-01 |
| OCO DENTAL IMPLANT (K010142) | O Co., Inc. | 2001-02-01 |
| CLIRANS E-SERIES HOLLOW FIBER DIALYZERS (K003425) | Terumo Medical Corp. | 2001-02-01 |
| ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER (K010099) | Zcv ,Inc. | 2001-02-01 |
| PROCLUDE-SENSITIVE (K003482) | Ortek Therapeutics, Inc. | 2001-02-01 |
| EYETECT TREMOR MONITOR UNIT (TMU) (K003644) | Eyetect, LLC | 2001-02-01 |
| CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES (K003840) | I.C Medical, Inc. | 2001-02-01 |
| POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMSPER OR LESS) (K003737) | Perusahaan Getah Asas Sdn. Bhd. | 2001-02-01 |
| KAPPA IMMAGE FREELITE KIT (K003669) | The Binding Site, Ltd. | 2001-02-01 |
| UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450 (K010056) | A & A Medical, Inc. | 2001-02-01 |
| STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS (K003615) | Environmental Test Systems, Inc. | 2001-02-01 |
| FLEXTIME MAGNUM 360 (K003930) | Heraeus Kulzer, Inc. | 2001-02-01 |
| PERSONAL GLUCOSE CONTROL CHARTING SYSTEM (K002688) | Lxn Corp. | 2001-02-01 |
| LAMBDA IMMAGE FREELITE KIT (K003671) | The Binding Site, Ltd. | 2001-02-01 |
| TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 (K002042) | New England Medical Corp. | 2001-02-01 |
| VERTEX SYSTEM (K002822) | Medical Positioning, Inc. | 2001-01-31 |
| EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM (K010003) | Ebi, L.P. | 2001-01-31 |
| LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES (K002445) | Medtronic Physio-Control Corp. | 2001-01-31 |
| LF-DP GASTROINTESTINAL AND SIGMOID FIBERSCOPE, ACCESSORIES AND ANCILLARY EQUIPMENT (K002231) | Olympus Optical Co., Ltd. | 2001-01-30 |
| CT PERFUSION 2 (K010042) | General Electric Co. | 2001-01-30 |
| APPALEAD GW+03XXXXXXR SERIES (K003394) | Nipro Medical Corp. | 2001-01-30 |
| BIOTEQUE VAGINAL DILATOR (K003380) | Bioteque America, Inc. | 2001-01-29 |
| EPI-DERM SILICONE GEL SHEETING (K003948) | Biodermis Corp. | 2001-01-29 |
| YASARGIL PERMANENT ANEURYSM CLIPS (K003519) | Aesculap, Inc. | 2001-01-29 |
| COLLES C SERIES FRAME STERILE PACK (K003397) | DePuy Orthopaedics, Inc. | 2001-01-29 |
| BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520 (K001543) | Welch Allyn, Inc. | 2001-01-29 |
| STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT (K003577) | STERIS Corporation | 2001-01-29 |
| CHASE CARDIOVASCULAR PATCH (K003467) | Chase Medical, Inc. | 2001-01-29 |
| STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE (K002273) | Stoeckert Instrumente | 2001-01-29 |
| LIQUIDERM LIQUID ADHESIVE BANDAGE (K002338) | Closure Medical Corp. | 2001-01-29 |
| NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM (K002791) | Unix Electronic Co. , Ltd. | 2001-01-29 |
| DIRECT BILIRUBIN (K003693) | Jas Diagnostics, Inc. | 2001-01-29 |
| GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FREE) (K010078) | Guthrie Medicare Products (Melaka) Sdn Bhd | 2001-01-29 |
| CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX (K003375) | Tecnilatex S.A. | 2001-01-28 |
| ELECSYS FSH CALSET II (K003409) | Roche Diagnostics Corp. | 2001-01-26 |
| THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERY (K002426) | Bioplate, Inc. | 2001-01-26 |
| PATIENT DRAPE, SURGICAL (K003670) | Advance Medical Designs, Inc. | 2001-01-26 |
| POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) (K003934) | Seltom Pacific Sdn. Bhd. | 2001-01-26 |
| FORMULA ONE POWDERED LATEX EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM 200 MICROGRAMS OR LESS AND MADE FROM A (K002719) | Tillotson Healthcare Corp. | 2001-01-26 |
| SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER) (K003407) | Ivoclar North America, Inc. | 2001-01-26 |
| SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII (K002652) | Stryker Corp. | 2001-01-26 |
| STERILE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) (K003653) | Wrp Asia Pacific Sdn. Bhd. | 2001-01-26 |
| MEDCOMP Z-CATH (K003682) | Medical Components, Inc. | 2001-01-26 |
| GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) (K010054) | Guthrie Medicare Products (Melaka) Sdn Bhd | 2001-01-26 |
| MODIFICATION TO FLUOROTEX II SURGICAL MESH (K003917) | Bridger Biomed, Inc. | 2001-01-26 |
| MEDLINE STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K003055) | Medline Industries, Inc. | 2001-01-26 |
| POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE (K010072) | Wrp Asia Pacific Sdn. Bhd. | 2001-01-26 |
| TEMPERATURE FUNCTION, MODEL 9500 MULTIGAS MONITOR (K003982) | Magnetic Resonance Equipment Corp. | 2001-01-26 |
| TIANXIE (K003748) | Suzhou Tianyi Acupuncture Instruments Co., Ltd. | 2001-01-26 |
| STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I (K002375) | OraSure Technologies, Inc. | 2001-01-26 |
| MODIFICATION TO FLUROTEX SURGICAL MESH (K003906) | Bridger Biomed, Inc. | 2001-01-26 |
| CARDIO MONITOR CENTER VISION; MODEL S-CV7-00 (K003392) | Shl Telemedicine International , Ltd. | 2001-01-25 |
| PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM (K003460) | Palomar Medical Technologies, Inc. | 2001-01-25 |
| SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS (K002007) | Sulzer Carbomedics, Inc. | 2001-01-25 |
| FMP METAL/METAL ACETABULAR INSERT (K003250) | Encore Orthopedics, Inc. | 2001-01-25 |
| DENLASER, MODEL 800 (K003541) | CAO Group, Inc. | 2001-01-25 |
| TWILITE, TWILITE WHITE (K003385) | Biolase Technology, Inc. | 2001-01-25 |