| ATLAS MULTI-PURPOSE DSA SYSTEM (K010391) | Cares Built, Inc. | 2001-03-12 |
| MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) (K010548) | Radionics, A Division of Tyco Healthcare Group LP | 2001-03-12 |
| PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) (K010126) | Cl-Tinters | 2001-03-12 |
| ATHENA REMOTE CONTROLLED RF SYSTEM (K010392) | Cares Built, Inc. | 2001-03-12 |
| D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM (K010082) | Dutch Ophthalmic USA, Inc. | 2001-03-12 |
| APOLLO MOBILE C ARM SYSTEM (K010393) | Cares Built, Inc. | 2001-03-12 |
| BD VISIDRAPE OPHTHALMIC DRAPES; BD VISIFLEX INCISE DRAPE (K010572) | Becton, Dickinson and Co. | 2001-03-12 |
| ERO SCAN OAE TEST SYSTEM (K010165) | Etymotic Research | 2001-03-12 |
| SONICAID FM820, SONICAID FM830 (K002150) | Oxford Instruments | 2001-03-09 |
| VCF PERSONAL LUBRICANT (K010182) | Apothecus Pharmaceutical Corp. | 2001-03-09 |
| MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM (K010367) | DePuy Orthopaedics, Inc. | 2001-03-09 |
| CENTURA PHOTOTHERAPY SPOTLIGHT (K010495) | Medical Illumination International, Inc. | 2001-03-09 |
| EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET) (K003867) | Biofilm, Inc. | 2001-03-09 |
| OPD-SCAN, MODELS ARK-10000 AND ARK-9000 (K003299) | Nidek Co., Ltd. | 2001-03-09 |
| NICOLET VERSALAB (K010521) | Nicolet Biomedical | 2001-03-09 |
| SLEEVED FILTER (K010040) | King Systems Corp. | 2001-03-09 |
| CARRIAZO BARRAQUER SINGLE USE MICROKERATOME (K003594) | Moria, Inc. | 2001-03-09 |
| ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS (K010390) | Acist Medical Systems, Inc. | 2001-03-09 |
| ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, 5.0 MM, ARTHREX TITANIUM CORKSCREW 6.5MM (K003816) | Arthrex, Inc. | 2001-03-09 |
| TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY (K010505) | Brentwood Medical Technology Corp. | 2001-03-09 |
| PVS 1300 NEURO GUIDE WIRE (K002907) | Precision Vascular Systems, Inc. | 2001-03-08 |
| PERFADEX SOLUTION FOR ORGAN PRESERVATION (K000881) | Vitrolife Sweden AB | 2001-03-08 |
| LIFECARE COMPACT TENS DEVICE (K003369) | Lifecare , Ltd. | 2001-03-08 |
| SEROJET (K003908) | Bioject, Inc. | 2001-03-08 |
| FOCUS DAILIES PROGRESSIVES (K003826) | Ciba Vision Corporation | 2001-03-08 |
| BENZ-MF (VISIBILITY HANGLING TINT) (METHAFILCON A) SOFT DAILY WEAR CONTACT LENS (LATHE-CUT) (K003861) | Benz Research and Development Corp. | 2001-03-08 |
| MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12 (K004034) | Branan Medical Corp. | 2001-03-08 |
| DISPOSABLE CB-PE MICROKERATOME BLADES (K003820) | Oasis Medical, Inc. | 2001-03-08 |
| HERACERAM 75 (K010416) | Jelenko Co. | 2001-03-08 |
| LASER 3 SPSC300 (K003058) | Pride Mobility Products Corp. | 2001-03-08 |
| KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652 (K010442) | Heinz Kurz | 2001-03-08 |
| PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER (K010426) | Sims Deltec, Inc. | 2001-03-08 |
| OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI (K003824) | Omnisonics Medical Technologies | 2001-03-08 |
| NEWTOM QR-DVT 9000 (K003787) | Aperio Services, LLC | 2001-03-08 |
| CONCENTRIC GUIDE CATHETER, MODELS 90018, 90020 (K003085) | Concentric Medical, Inc. | 2001-03-07 |
| INFINITY ETCO2 + RESPIRATORY MECHANICS POD (K003550) | Siemens Medical Solutions USA, Inc. | 2001-03-07 |
| FLEXVIEW CLINICAL MONITORING SYSTEM (K003998) | Data Critical Corp. | 2001-03-07 |
| ENDOCARE PERCUTANEOUS ACCESS SET (K010339) | Endocare, Inc. | 2001-03-07 |
| ALLOFIT ACETABULAR SYSTEM (K003758) | Sulzer Orthopedics, Inc. | 2001-03-07 |
| ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200 (K010338) | Medivance, Inc. | 2001-03-07 |
| SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW (K002274) | Smith & Nephew, Inc. | 2001-03-07 |
| SCIMEDX PHASE II MPO IGG ANTIBODY EIA (K010289) | Scimedx Corp. | 2001-03-07 |
| BREAS HA50 HUMIDIFIER, MODEL HA50 (K002454) | Vital Signs, Inc. | 2001-03-07 |
| SLT DIFFUSER FIBER (K010041) | Surgical Laser Technologies, Inc. | 2001-03-07 |
| SUPERCROSS CATHETER (K001856) | Abbott Vascular, Inc. | 2001-03-07 |
| GENERAL SURGICAL LAPAROSCOPES (K003803) | Global Endoscopy, Inc. | 2001-03-07 |
| ACCU-CHEK COMFORT CURVE TEST STRIP (K010362) | Roche Diagnostics Corp. | 2001-03-07 |
| MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K010419) | Masimo Corp. | 2001-03-06 |
| SWABSITE SWABBABLE VALVE, MODEL 245000 (K002689) | Quest Medical, Inc. | 2001-03-06 |
| FETAL ASSIST (K002548) | Huntleigh Diagnostics , Ltd. | 2001-03-06 |
| CARIS SITE MARKER (K003777) | Artemis Medical, Inc. | 2001-03-06 |
| D.SIGN 30 (K010381) | Ivoclar North America, Inc. | 2001-03-06 |
| SHAVER ABLATOR (K002088) | Linvatec Corp. | 2001-03-06 |
| SUSCEPTIBILITY TEST PANEL (K004045) | Trek Diagnostic Systems, Inc. | 2001-03-06 |
| INJEX 50 SYSTEM (K003864) | Equidyne Systems, Inc. | 2001-03-06 |
| LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) (K003765) | Laserscope | 2001-03-06 |
| VIGIL SEROLOGY CONTROL LEVEL C (K010358) | Beckman Coulter, Inc. | 2001-03-05 |
| GRAMS POLYESTER NONABSORBABLE SUTURE (K003590) | Gramsmed, LLC | 2001-03-05 |
| MENTOR SELF-CATH PLUS (K003784) | Mentor Corp. | 2001-03-05 |
| MULTI CARE THERAPEUTIC VIBRATOR (K010096) | Multicept A/S | 2001-03-05 |
| SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050 (K002468) | San UP S.A. | 2001-03-02 |
| M2376A DEVICELINK SYSTEM (K010453) | Agilent Technologies, Inc. | 2001-03-02 |
| TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP (K000180) | Richard Wolf Medical Instruments Corp. | 2001-03-02 |
| SNAP MODEL 6 (K002095) | Snap Laboratories, LLC | 2001-03-02 |
| HOMMED SENTRY III PATIENT MONITOR SYSTEM (K004044) | Hommed, LLC | 2001-03-02 |
| ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U (K010330) | Arrow Intl., Inc. | 2001-03-02 |
| INTUITIVE SURGICAL DA VINCI ENDOSCOPIC CONTROL SYSTEM (K002489) | Intuitive Surgical, Inc. | 2001-03-02 |
| TAKE 1 (K003808) | Sybron Dental Specialties, Inc. | 2001-03-01 |
| CONTOUR PROFILE LASER (K010285) | Sciton, Inc | 2001-03-01 |
| LASER 4SPSC340 (K003059) | Pride Mobility Products Corp. | 2001-03-01 |
| SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 (K003329) | Sigma Diagnostics, Inc. | 2001-03-01 |
| 100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I (K010382) | Sensidyne, Inc. | 2001-03-01 |
| 240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS (K003725) | Pie Medical | 2001-03-01 |
| ENA EIA KIT RANGE (K010146) | The Binding Site, Ltd. | 2001-03-01 |
| PROFOX SOFTWARE, MODEL 920M-41 (K001708) | Respironics Georgia, Inc. | 2001-03-01 |
| LOGIQ 500 (K010329) | General Electric Co. | 2001-03-01 |
| INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DETACHABLE ENDODCOPIC INSTRUMENTS 5 MM, 10MM (HANDLE, SHAF (K003717) | Tekno Medical Optik-Chirurgie GmbH & Co. | 2001-03-01 |
| BD ECLIPSE HYPODERMIC NEEDLE (K010188) | Bd Medical Systems | 2001-03-01 |
| MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM (K010320) | Depuyacromed | 2001-03-01 |
| COOLTOUCH ND:YAG LASER SYSTEM, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH II (K003715) | Cooltouch Corp. | 2001-03-01 |
| PALOMAR SPALIGHT PULSED LIGHT SYSTEM (K003886) | Palomar Medical Technologies, Inc. | 2001-03-01 |
| ELECSYS TESTOSTERONE CALSET II (K003411) | Roche Diagnostics Corp. | 2001-03-01 |
| TI-REPLICA HIP STEM (K003875) | DePuy Orthopaedics, Inc. | 2001-03-01 |
| ASTRONOMER+WITH SLD (K003362) | Boston Scientific Corp | 2001-03-01 |
| ENA EIA KIT (K010147) | The Binding Site, Ltd. | 2001-03-01 |
| VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X (K003893) | Oratec Interventions, Inc. | 2001-03-01 |
| XTRAC EXCIMER LASER SYSTEM, MODEL AL7000 (K003705) | Photo Medex, Inc. | 2001-03-01 |
| ACCUCLOT CONTROL I, MODEL A4089 (K003328) | Sigma Diagnostics, Inc. | 2001-03-01 |
| MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES (K010511) | Cordis Neurovascular, Inc. | 2001-03-01 |
| CARDIOMEDICS ECP SYSTEM (K010261) | Cardiomedics, Inc. | 2001-02-28 |
| DUAL LUMEN MIDLINE CATHETER (K010349) | Catheter Innovations, Inc. | 2001-02-28 |
| ZOLL M SERIES (K010257) | Zoll Medical Corp | 2001-02-28 |
| HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVES (K010077) | Pwa Industries Sdn. Bhd. | 2001-02-28 |
| VASCULAR ARCHITECTS PERISCOPE DEVICE (K003719) | Vascular Architects, Inc. | 2001-02-28 |
| ALI 3D TOOL MODULE FOR MEDICAL IMAGES (K003762) | A.L.I. Technologies, Inc. | 2001-02-28 |
| MAC ACUPUNCTURE NEEDLE (K002827) | Haenglim Seowon Corp. | 2001-02-28 |
| COBAS INTEGRA AMPHETAMINES (K003865) | Roche Diagnostics Corp. | 2001-02-28 |
| TETRIC CERAM HB (K010250) | Ivoclar North America, Inc. | 2001-02-28 |
| ANATOMICAL PRESS-FIT HUMERAL STEM (K003801) | Sulzer Orthopedics, Inc. | 2001-02-28 |
| CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK (K010111) | Medical Analysis Systems, Inc. | 2001-02-28 |