| SMITH & NEPHEW SUTURE ANCHOR (K003599) | Smith & Nephew, Inc. | 2001-02-15 |
| ACCUFUSER; ACCUFUSER PLUS (K003915) | Help Technologies | 2001-02-15 |
| DYONICS CONTROL RF SYSTEM (K003572) | Smith & Nephew, Inc. | 2001-02-15 |
| DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET (K003977) | Disetronic Medical Systems AG | 2001-02-15 |
| NITRILE EXAMINATION GLOVES (POWERED) (K003922) | Guthrie Medicare Products (Melaka) Sdn Bhd | 2001-02-15 |
| ANA EIA DIAGNOSTIC TEST KIT (K004019) | The Binding Site, Ltd. | 2001-02-15 |
| A & I WHEELCHAIRS (K010094) | Taiwan an I Co., Ltd. | 2001-02-15 |
| OFFSET TIBIAL TRAY (K010212) | Biomet, Inc. | 2001-02-14 |
| COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS (K003566) | Smith & Nephew, Inc. | 2001-02-14 |
| PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING (K003936) | Tomtec Imaging Systems GmbH | 2001-02-14 |
| TEKNIQUE (K010075) | Hoveround Corp. | 2001-02-14 |
| CONSTELLATION CATHETER, MODEL 8031 (K003782) | Boston Scientific Corp | 2001-02-14 |
| PROFILE II ER (K010138) | Medtox Diagnostics, Inc. | 2001-02-14 |
| MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND 2.7-5.0MM MODEL MMD-4700 SERIES (K003695) | Micro-Medical Devices, Inc. | 2001-02-14 |
| BIOLUCENT MAMMOGRAPHY CUSHION (K003795) | Biolucent, Inc. | 2001-02-14 |
| IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600) (K004002) | Diagnostic Products Corp. | 2001-02-14 |
| KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A (K010246) | Kyphon, Inc. | 2001-02-14 |
| DELFIA NEONATAL IRT KIT, MODEL A005-110 (K003664) | Wallac OY | 2001-02-14 |
| TITANIUM CEMENT RESTRICTOR (TCR) (K003718) | Medtronic Sofamor Danek, Inc. | 2001-02-14 |
| KIMAX, MODEL 1024 (K010187) | Medical Metrics, Inc. | 2001-02-14 |
| M2376A DEVICELINK SYSTEM, MODEL M2376A (K010342) | Agilent Technologies, Inc. | 2001-02-14 |
| ELECSYS HCG+B CALCHECK (K010237) | Roche Diagnostics Corp. | 2001-02-14 |
| BMR DENTAL IMPLANT SYSTEM, MODEL 3.3XX, EITHER HA OR TPS COATED, 3.308, 3.310,3.312, 3.314 3.316 (K010343) | Buck Medical Research | 2001-02-14 |
| REVEAL PLUS INSERTABLE LOOP RECORDER (K003667) | Medtronic Vascular | 2001-02-14 |
| SYNTRA DIALYZER, MODEL SYNTRA 120, 160 (K002210) | Baxter Healthcare Corp | 2001-02-14 |
| TENSCARE, MODEL TENS XL-2 (K003591) | Tenscare, Ltd. | 2001-02-14 |
| RCRP FLEX REAGENT CARTRIDGE (K003419) | Dade Behring, Inc. | 2001-02-14 |
| LC PROVIFILL (K010012) | S & C Polymer GmbH | 2001-02-14 |
| INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET (K001329) | Lifemed of California | 2001-02-14 |
| LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR (K010030) | Synergent Biochem Inc.-Clinical Controls Div. | 2001-02-14 |
| BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER (K010169) | C.R. Bard, Inc. | 2001-02-13 |
| SALUTE (K003522) | Onux Medical, Inc. | 2001-02-13 |
| INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100 (K003853) | Philips Medical Systems (Cleveland), Inc. | 2001-02-13 |
| MOJAVE CATARACT EXTRACTION SYSTEM (K003638) | Allergan, Inc. | 2001-02-13 |
| SPECIALTY 55 & MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENSES FOR DAILY WEAR (K003833) | Clearlab Pte , Ltd. | 2001-02-13 |
| BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR & BLUE VISIBILITY TINT, LATHE (K001585) | American Biocurve, Inc. | 2001-02-13 |
| ORBITER II CCI/SPECT ORBITER II CCI/SPECT (K010137) | Siemens Medical Solutions USA, Inc. | 2001-02-13 |
| TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM (K002583) | Vidamed, Inc. | 2001-02-13 |
| FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065 (K010004) | Micro Therapeutics, Inc. | 2001-02-13 |
| MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI (K010340) | Karl Storz Lithotripsy-America, Inc. | 2001-02-13 |
| INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500 (K003510) | Visualization Technology, Inc. | 2001-02-12 |
| SPECIALTY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY 55 UV MULTIFOCAL (METHAFILCON) (K003526) | Specialty Ultravision, Inc. | 2001-02-12 |
| ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200 (K003514) | Shimadzu Medical Systems | 2001-02-12 |
| AUTODELFIA NEONATAL IRT KIT, MODEL B005-112 (K003668) | Wallac OY | 2001-02-12 |
| SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS (K003529) | Edap Technomed, Inc. | 2001-02-12 |
| MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175 (K003858) | Phamatech | 2001-02-12 |
| SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE (K003571) | Terumo Medical Corp. | 2001-02-12 |
| SERENOCEM, MODEL BC 010 (K003567) | Corinthian Medical , Ltd. | 2001-02-12 |
| ASSERACHROM HPIA TEST KIT (K003767) | Diagnostica Stago, Inc. | 2001-02-12 |
| TOTAL BILIRUBIN (K003829) | Jas Diagnostics, Inc. | 2001-02-12 |
| VORTEX ACCESS SYSTEM (K010189) | Horizon Medical Products, Inc. | 2001-02-12 |
| LORENZ RESORBABLE DISTRACTOR SYSTEM (K002083) | Walter Lorenz Surgical, Inc. | 2001-02-12 |
| MXR-2000 MOBILE X-RAY UNIT (K010304) | Irom Imaging, Inc. | 2001-02-12 |
| ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200 (K003515) | Shimadzu Medical Systems | 2001-02-12 |
| SONIC MODEL SO-300 (K010102) | Metron Medical Australia, Pty, Ltd. | 2001-02-09 |
| STERILE BUTTON PLATE (K010121) | Synthes (Usa) | 2001-02-09 |
| SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM (K003743) | Synthes (Usa) | 2001-02-09 |
| AML HIP PROSTHESIS (K003800) | DePuy Orthopaedics, Inc. | 2001-02-09 |
| MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH OFF-SET NECK SEGMENT, M-SERIES LOW OFF-SET NECK S (K010120) | Exactech, Inc. | 2001-02-09 |
| EBI VUECATH SPINAL ENDOSCOPIC SYSTEM (K010179) | Ebi, L.P. | 2001-02-09 |
| TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP (K993856) | Tuttnauer U.S.A Co, Ltd. | 2001-02-09 |
| 64 CHANNEL EEG / MODEL NUMBER EX-NW-64 (K010150) | Excel Tech. , Ltd. | 2001-02-09 |
| POWDERFREE NITRILE PATIENT EXMINATION GLOVE (K003985) | Guthrie Medicare Products (Melaka) Sdn Bhd | 2001-02-09 |
| JK GLOVES PRE-POWDERED LATEX EXAMINATION GLOVE (K010231) | Jk Gloves Sdn. Bhd. | 2001-02-09 |
| COSMIC (K010044) | Jeneric/Pentron, Inc. | 2001-02-09 |
| NONSTERILE POWDERED PURPLE LATEX EXAMINATION GLOVES, WITH & WITHOUT GRAPE SCENT WITH PROTEIN LABELING (200 MICROGRAMS OR (K010095) | Sgmp Co., Ltd. | 2001-02-09 |
| REMVIEW SLEEP RECORDER, MODEL 320 (K003499) | Respironics, Inc. | 2001-02-09 |
| (DISPOSABLE) VAGINAL SPECULUM (K003540) | Feminica, Inc. | 2001-02-09 |
| 3I CALCIUM SODIUM PHOSPHATE BONE CEMENT (K003493) | Biomet, Inc. | 2001-02-09 |
| LATERAL OFFSET PROTRACT PRESS FIT HIP STEM (K010282) | Stelkast Company | 2001-02-09 |
| ORG-9200A (K002068) | Nihon Kohden America, Inc. | 2001-02-08 |
| 2010 PLUS HOLTER FOR WINDOWS (K003940) | Agilent Technologies | 2001-02-08 |
| CEMEX SYSTEM GUN APPLICATION VERSION (K000943) | Exactech, Inc. | 2001-02-08 |
| FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES (K003586) | Ciba-Geigy Corp. | 2001-02-08 |
| WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A43 (K010190) | Rossmax Internationl , Ltd. | 2001-02-08 |
| ENVIVE MINIFORMS (K003843) | Procter & Gamble Co. | 2001-02-08 |
| TAPER-FIT TOTAL HIP SYSTEM (K003666) | Corin USA | 2001-02-08 |
| EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET (K003627) | Exelint International, Co. | 2001-02-08 |
| LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II (K003512) | A.R.C. Laser AG | 2001-02-08 |
| THERMO TEK IR FOREHEAD THERMOMETER, MODEL 718F (K002712) | Saat , Ltd. | 2001-02-08 |
| STYLET KIT, MODELS 6254,6282,6293 (K003535) | Medtronic Vascular | 2001-02-08 |
| CANNULATED SCREW SYSTEM (K003496) | Pioneer Surgical Technology | 2001-02-08 |
| BIOLOK SCREW, BIOSTEON SCREW (K003641) | Biocomposites, Ltd. | 2001-02-08 |
| RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM (K010068) | Rusch Intl. | 2001-02-08 |
| PROTRACT PRESS FIT HIP STEM-HA COATED (K010241) | Stelkast Company | 2001-02-08 |
| 4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190 (K010064) | Beckman Coulter, Inc. | 2001-02-07 |
| ULTRASOUND SCANNER TYPE 2101 (K003041) | B-K Medical A/S | 2001-02-07 |
| ANCURE LLIAC BALLOON CATHETER (K003495) | Guidant Cardiac and Vascular Surgery | 2001-02-07 |
| THERMOFX MESH (K003757) | Bionx Implants, Ltd. | 2001-02-07 |
| ADAPTERS WITH X-COATING (K003604) | Terumo Cardiovascular Systems Corp. | 2001-02-07 |
| IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) (K002469) | W&H Dentalwerk Buermoos GmbH | 2001-02-07 |
| HOLY DRAGON ACUPUNCTURE NEEDLES (K002910) | Anc Import & Export Co. , Ltd. | 2001-02-07 |
| MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP (K000776) | Medtronic Cardiac Surgical Products | 2001-02-07 |
| CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L (K003533) | Steritec Products, Inc. | 2001-02-07 |
| BIO-EYE II ORBITAL IMPLANT (K003338) | Integrated Orbital Implants, Inc. | 2001-02-07 |
| POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103 (K010130) | Medtronic Functional Diagnostics A/S | 2001-02-07 |
| 5C-ES CELL CONTROL, MODELS 7547191, 7547192 (K010066) | Beckman Coulter, Inc. | 2001-02-07 |
| ACTHERM DIGITAL CLINICAL THERMOMETER, MODELS ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+ (K010238) | Actherm, Inc. | 2001-02-06 |
| SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K004048) | Tillotson Healthcare Corp. | 2001-02-06 |
| SHANGHAI CHINASTAR POWER-FREE BLUE NITRIL EXAMINATION GLOVES (K010247) | Shanghai China Star Corp | 2001-02-06 |