| COOK PRESSURE MONITORING CATHETER (K002254) | Cook, Inc. | 2001-03-16 |
| DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES (K010463) | Datex-Ohmeda, Inc. | 2001-03-15 |
| PANASONIC TELE-HOMECARE SYSTEM (K004050) | Matsushita Electric Industrial Co., Ltd. | 2001-03-15 |
| GALIX GBI -3S-LP (K992706) | Galix Biomedical Instrumentation, Inc. | 2001-03-15 |
| ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS (K010390) | Acist Medical Systems, 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 |
| CONCENTRIC GUIDE CATHETER, MODELS 90018, 90020 (K003085) | Concentric Medical, Inc. | 2001-03-07 |
| FLEXVIEW CLINICAL MONITORING SYSTEM (K003998) | Data Critical Corp. | 2001-03-07 |
| ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200 (K010338) | Medivance, Inc. | 2001-03-07 |
| SUPERCROSS CATHETER (K001856) | Abbott Vascular, Inc. | 2001-03-07 |
| MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K010419) | Masimo Corp. | 2001-03-06 |
| M2376A DEVICELINK SYSTEM (K010453) | Agilent Technologies, Inc. | 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 |
| PROFOX SOFTWARE, MODEL 920M-41 (K001708) | Respironics Georgia, Inc. | 2001-03-01 |
| ASTRONOMER+WITH SLD (K003362) | Boston Scientific Corp | 2001-03-01 |
| MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES (K010511) | Cordis Neurovascular, Inc. | 2001-03-01 |
| CARDIOMEDICS ECP SYSTEM (K010261) | Cardiomedics, Inc. | 2001-02-28 |
| ZOLL M SERIES (K010257) | Zoll Medical Corp | 2001-02-28 |
| VASCULAR ARCHITECTS PERISCOPE DEVICE (K003719) | Vascular Architects, Inc. | 2001-02-28 |
| FIRSTSAVE BIPHASIC MODEL #9200 AND 9210 (K010214) | Survivalink Corp. | 2001-02-22 |
| AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A (K002758) | Agilent Technologies Deutschland GmbH | 2001-02-22 |
| MULTI-FUNCTION DEFIBRILLATION ELECTRODE (K002079) | Medicotest A/S | 2001-02-22 |
| PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE (K001852) | Itamar Medical (C.M.) 1997 , Ltd. | 2001-02-21 |
| X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-1 (K002054) | Appriva Medical, Inc. | 2001-02-16 |
| CONSTELLATION CATHETER, MODEL 8031 (K003782) | Boston Scientific Corp | 2001-02-14 |
| M2376A DEVICELINK SYSTEM, MODEL M2376A (K010342) | Agilent Technologies, Inc. | 2001-02-14 |
| REVEAL PLUS INSERTABLE LOOP RECORDER (K003667) | Medtronic Vascular | 2001-02-14 |
| BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER (K010169) | C.R. Bard, Inc. | 2001-02-13 |
| FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065 (K010004) | Micro Therapeutics, Inc. | 2001-02-13 |
| ORG-9200A (K002068) | Nihon Kohden America, Inc. | 2001-02-08 |
| 2010 PLUS HOLTER FOR WINDOWS (K003940) | Agilent Technologies | 2001-02-08 |
| WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A43 (K010190) | Rossmax Internationl , Ltd. | 2001-02-08 |
| STYLET KIT, MODELS 6254,6282,6293 (K003535) | Medtronic Vascular | 2001-02-08 |
| ANCURE LLIAC BALLOON CATHETER (K003495) | Guidant Cardiac and Vascular Surgery | 2001-02-07 |
| ADAPTERS WITH X-COATING (K003604) | Terumo Cardiovascular Systems Corp. | 2001-02-07 |
| MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP (K000776) | Medtronic Cardiac Surgical Products | 2001-02-07 |
| PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602 (K002280) | Medical Devices, Inc. | 2001-02-05 |
| BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE (K990284) | Baylis Medical Co., Inc. | 2001-02-01 |
| M2376A DEVICELINK SYSTEM (K010048) | Agilent Technologies, Inc. | 2001-02-01 |
| ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER (K010099) | Zcv ,Inc. | 2001-02-01 |
| VERTEX SYSTEM (K002822) | Medical Positioning, Inc. | 2001-01-31 |
| LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES (K002445) | Medtronic Physio-Control Corp. | 2001-01-31 |
| APPALEAD GW+03XXXXXXR SERIES (K003394) | Nipro Medical Corp. | 2001-01-30 |
| BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520 (K001543) | Welch Allyn, Inc. | 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 |
| NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM (K002791) | Unix Electronic Co. , Ltd. | 2001-01-29 |
| CARDIO MONITOR CENTER VISION; MODEL S-CV7-00 (K003392) | Shl Telemedicine International , Ltd. | 2001-01-25 |
| SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS (K002007) | Sulzer Carbomedics, Inc. | 2001-01-25 |
| Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503 (K003576) | Quinton, Inc. | 2001-01-25 |
| DR180+OXY (K004007) | North East Monitoring, Inc. | 2001-01-25 |
| STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE (K001961) | Stoeckert Instrumente | 2001-01-25 |
| INTRODEUCE DOUBLE LUMEN INTRODUCER (K001985) | Cook, Inc. | 2001-01-25 |
| ACROTHERM (K003368) | Aquarius Medical Corp. | 2001-01-19 |
| TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306B (K003964) | Cordis Corp. | 2001-01-19 |
| A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR (K002061) | A&D Engineering, Inc. | 2001-01-19 |
| ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING; CH 2000 CARDIAC DIAGNOSTIC SYSTEM; HEARTWAVE ALTERNANS PROCESSING SYS (K003492) | Cambridge Heart, Inc. | 2001-01-18 |
| A1-CS-SB Y-ADAPTER, MODEL 124 871 (K003454) | Biotronik, Inc. | 2001-01-18 |
| TRAK BACK II (K003938) | Jomed, Inc. | 2001-01-18 |
| PHLEBOPUMP, MODEL 1000 (K003284) | Prevent Products, Inc. | 2001-01-17 |
| ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER (K003901) | AngioDynamics, Inc. | 2001-01-17 |
| ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM (K001775) | Zoe Medical, Inc. | 2001-01-12 |
| MULTITRACK ANGIOGRAPHIC CATHETER (K003902) | NuMED, Inc. | 2001-01-11 |
| NUMED GHOST II PTA CATHETERS (K003972) | NuMED, Inc. | 2001-01-11 |
| RADIANALYZER, MODEL 12710 (K002067) | Radi Medical Systems AB | 2001-01-11 |
| CARE PROVIDER STATION ADDITION OF WEIGHT SCALE (K003485) | Cybercare Technologies, Inc. | 2001-01-11 |
| OUTBACK CATHETER (K001577) | Lumend, Inc. | 2001-01-11 |
| PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES (K003072) | Biotronik, Inc. | 2001-01-09 |
| VENODYNE DVT ADVANTAGE MODEL 610 (K001802) | Microtek Medical, Inc. | 2001-01-09 |
| ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER (K002603) | Zcv ,Inc. | 2001-01-08 |
| FLEXIBLE OCCLUSION SYSTEM (K002915) | Applied Medical | 2001-01-08 |
| KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH EC (K001896) | Suzuken Co., Ltd. | 2001-01-08 |
| PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS (K003925) | Cordis Neurovascular, Inc. | 2001-01-08 |
| INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS (K990800) | Intervascular, Inc. | 2001-01-08 |
| 2010 PLUS HOLTER FOR WINDOWS (K003763) | Agilent Technologies | 2001-01-05 |
| ULTIMUM EV HEMOSTASIS INTRODUCER (14F), ULTIMUM EV HEMOSTASIS INTRODUCER (16F), ULTIMUM EV HEMOSTASIS INTRODUCER (18F), (K003729) | St Jude Medical | 2001-01-03 |
| ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE (K003415) | Wang & Li, Inc. | 2001-01-03 |
| SURGISIS PERIPHERAL VASCULAR PATCH (K001785) | Cook Biotech, Inc. | 2000-12-27 |
| NUMED Z-MED PTV CATHERERS (K003643) | NuMED, Inc. | 2000-12-27 |
| CARTOUCH (K002197) | Cardionics, Inc. | 2000-12-27 |
| RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX (K002976) | St Jude Medical | 2000-12-22 |
| SIEMENS INFINITY MODULAR MONITORS MODEL SC 8000; SC 7000; SC 9000XL (K003243) | Siemens Medical Solutions USA, Inc. | 2000-12-21 |
| EMPIRE N BLOOD PRESSURE MANOMETERS (K002955) | Rudolf Riester GmbH & Co. KG | 2000-12-21 |
| MSD EMBOLECTOMY BASKET (K991093) | Metamorphic Surgical Devices, LLC | 2000-12-21 |
| CARDIOSENTRY EVENT MONITOR, MODEL 8470-01 (K001634) | Tz Medical, Inc. | 2000-12-21 |
| RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS (K002954) | Rudolf Riester GmbH & Co. KG | 2000-12-21 |
| SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER (K003248) | Siemens Medical Solutions USA, Inc. | 2000-12-21 |
| PUMP TUBING WITH X-COATING (K003371) | Terumo Corp. | 2000-12-21 |
| DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320 (K003598) | Datascope Corp. | 2000-12-21 |
| CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B (K003724) | Medtronic Vascular | 2000-12-21 |
| SIEMENS MULTI VIEW WORKSTATION WITH VENT VIEWER OPTION (K003246) | Siemens Medical Solutions USA, Inc. | 2000-12-21 |
| ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0 (K003621) | Agilent Technologies, Inc. | 2000-12-20 |
| Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 (K003118) | Zcv ,Inc. | 2000-12-20 |
| HEARTSTREAM FR2 AED, MODEL M3860A,M3861A (K003565) | Agilent Technologies, Inc. | 2000-12-20 |
| VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME (K001927) | Thoratec Laboratories Corp. | 2000-12-18 |
| M2376A DEVICELINK SYSTEM, MODEL M2376A (K003622) | Agilent Technologies, Inc. | 2000-12-18 |
| EHC400 DESKTOP PATIENT STATION; EHC600 CARE PROVIDER STATION (K002984) | Cybercare Technologies, Inc. | 2000-12-18 |
| AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P (K003711) | Sein Electronics Co., Ltd. | 2000-12-15 |