| CARDIOSEN'C (K080047) | Shl Telemedicine International , Ltd. | 2008-07-11 |
| NUCLEUS-X, MODEL 230X (K081680) | NuMED, Inc. | 2008-07-10 |
| REPROCESSED ELECTROPHYSIOLOGY CATHETERS (K081329) | Ascent Healthcare Solutions | 2008-07-09 |
| VASCON ROAMER MICROCATHETER (K053310) | Vascon, LLC | 2008-07-03 |
| KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K080319) | Andon Health Co, Ltd. | 2008-07-02 |
| WRIST PULSE OXIMETER MD300W (K081125) | Beijing Choice Electronic Technololgy Co., Ltd. | 2008-07-02 |
| PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER (K080813) | Radi Medical Systems AB | 2008-07-01 |
| SENSEI CATHETER CONTROL SYSTEM (K073225) | Hansen Medical, Inc. | 2008-06-30 |
| HERO, VERSION 2.0 (K081473) | Medical Predictive Science Corp. | 2008-06-27 |
| ORQIS EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL BPS-100 (K073631) | Orqis Medical Corporation | 2008-06-27 |
| INTEL HEALTH GUIDE, MODEL: PHS6000 (K080798) | Intel Corp. | 2008-06-27 |
| FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12 (K081049) | Cryocath Technologies, Inc. | 2008-06-27 |
| MEDTRONIC EXPORT AP CATHETER (K081573) | Medtronic Vascular | 2008-06-27 |
| EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION (K081467) | Ekos Corp. | 2008-06-26 |
| ECARD AND CCARD (K081471) | iRhythm Technologies, Inc. | 2008-06-24 |
| BENEVIEW T SERIES PATIENT MONITORS, MODELS T8, T6 AND T5 (K073280) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008-06-23 |
| HORIZON XVU (K081484) | Mennen Medical , Ltd. | 2008-06-20 |
| PATIENT CABLE (K080112) | Med-Dyne | 2008-06-20 |
| APEXPRO TELEMETRY SYSTEMS (K080251) | Ge Medical Systems Information Technologies | 2008-06-20 |
| CROSSER LP SYSTEM (K080765) | Flowcardia, Inc. | 2008-06-20 |
| YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP-600J (K081590) | Ya Horng Electronic Co., Ltd. | 2008-06-19 |
| LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE (K081221) | Levitronix, LLC | 2008-06-19 |
| OCCLUSION BALLOON CATHETER, MODEL VENOS (K081052) | Oscor, Inc. | 2008-06-18 |
| THREE STAGE VENOUS RETURN CANNULA, MODEL 816460 (K080034) | Terumo Cardiovascular Systems Corp. | 2008-06-17 |
| GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE (K081454) | Possis Medical, Inc. | 2008-06-13 |
| DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES (K080366) | Zefon Intl. | 2008-06-09 |
| SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100 (K073712) | Adroit Medical Systems, Inc. | 2008-06-06 |
| TR-USB TELEPHONIC STETHOSCOPE (K081032) | Rnk Products, Inc. | 2008-06-06 |
| FINGER PULSE OXIMETER, MODEL 9560 (K081285) | Nonin Medical, Inc. | 2008-06-05 |
| MERCI RETRIEVER (K081305) | Concentric Medical, Inc. | 2008-06-05 |
| FOXCROSS PTA CATHETER (K081417) | Abbott Vascular, Inc. | 2008-06-04 |
| IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM (K063723) | Abiomed, Inc. | 2008-05-30 |
| TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT (K080763) | Talley Medical | 2008-05-30 |
| AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2 (K081035) | Osypka Medical, Inc. | 2008-05-30 |
| GENESIS ECP (K081359) | Scottcare Corporation | 2008-05-29 |
| CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR (K081257) | Card Guard Scientific Survival , Ltd. | 2008-05-29 |
| HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861 (K080424) | Hygia Health Services, Inc. | 2008-05-28 |
| DESTINATION RENAL GUIDING SHEATH (K081045) | Terumo Medical Corp. | 2008-05-28 |
| UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE DEVICE (K080551) | University of Utah Hospitals and Clinics | 2008-05-28 |
| MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER (K081220) | Angioscore, Inc. | 2008-05-28 |
| NRG TRANSSEPTAL NEEDLE (K073326) | Baylis Medical Co., Inc. | 2008-05-28 |
| NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER (K080255) | Nonin Medical, Inc. | 2008-05-23 |
| PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH (K081046) | Terumo Medical Corp. | 2008-05-21 |
| DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE (K071889) | GE Healthcare | 2008-05-19 |
| AMPLATZER TORQVUE EXCHANGE SYSTEM (K080994) | Aga Medical Corp. | 2008-05-16 |
| HEARTRAK AF (K071130) | Universal Medical, Inc. | 2008-05-14 |
| INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C (K080769) | Somanetics Corp. | 2008-05-14 |
| REINFORCED CATHETER INTRODUCER SYSTEM (RCIS) (K081341) | Thomas Medical Products, Inc. | 2008-05-14 |
| MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MQ1-2D (K080337) | Microlife Corp. | 2008-05-13 |
| REVOLUTION 45MHZ IVUS IMAGING CATHETER (K080891) | Volcano Corporation | 2008-05-12 |
| MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER (K080238) | Masimo Corporation | 2008-05-12 |
| WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV (K080177) | Nihon Seimitsu Sokki Co., Ltd. | 2008-05-09 |
| PAGEWRITER CARDIOGRAPH (K080999) | Philips Medical Systems | 2008-05-09 |
| BIO-CONSOLE 560 (K080824) | Medtronic Perfusion Systems | 2008-05-07 |
| SCOUTPRO CS LEAD INTRODUCER SYSTEM (K080988) | Biotronik, Inc. | 2008-05-07 |
| OPTISTAR ELITE INJECTION SYSTEM (K073592) | Mallinckrodt Inc., Liebel-Flarsheim Business | 2008-05-07 |
| FINGERTIP PULSE OXIMETER, MODEL CMS-50C (K073454) | Contec Medical System Co., Ltd. | 2008-05-05 |
| SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL (K080605) | Curbell Electronics, Inc. | 2008-05-05 |
| MEDIAID M960 SERIES, VITAL SIGNS MONITOR AND MEDIAID M900 SERIES, PULSE OXIMETER (K071642) | Mediaid, Inc. | 2008-05-02 |
| ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301 (K072696) | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2008-05-02 |
| EndoWave Infusion System (K080392) | Ekos Corp. | 2008-04-30 |
| MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 (K080924) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2008-04-30 |
| FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01 (K080621) | European Custom Manufacturing BV | 2008-04-29 |
| FOX PLUS PTA CATHETER (K080925) | Abbott Vascular, Inc. | 2008-04-28 |
| ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039 (K080151) | Angioscore, Inc. | 2008-04-25 |
| PC ECG 1200W SYSTEM (K080141) | Norav Medical , Ltd. | 2008-04-25 |
| INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 (K072932) | Infraredx, Inc. | 2008-04-25 |
| ZOLL E SERIES DEFIBRILLATOR (K072923) | Zoll Medical Corporation, World Wide Headquarters | 2008-04-24 |
| CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02 (K080425) | Biosense Webster, Inc. | 2008-04-23 |
| ZOLL E SERIES 12SL, ANALYSIS OPTION (K080232) | Zoll Medical Corporation, World Wide Headquarters | 2008-04-23 |
| AMBULO 2400 (K080274) | Tiba Medical, Inc. | 2008-04-23 |
| SEDAT MYSHELL LITE (K080472) | Sedat | 2008-04-23 |
| MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM (K080670) | Atcor Medical | 2008-04-23 |
| ENDOWAVE INFUSION SYSTEM (K073166) | Ekos Corp. | 2008-04-22 |
| AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM (K080757) | Aga Medical Corp. | 2008-04-18 |
| INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904 AND 7905 (K073585) | Vascular Solutions, Inc. | 2008-04-17 |
| TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE (K080863) | MicroVention, Inc. | 2008-04-17 |
| CAPIOX SP PUMP (WITH OR WITHOUT X-COATING) (K080774) | Terumo Cardiovascular Systems Corp. | 2008-04-17 |
| LIFE+CEL OR LIFECEL BATTERY (K073716) | Amco International Manufacturing & Design, Inc. | 2008-04-11 |
| INTOUCH REMOTE PRESENCE ROBOTIC SYSTEM, MODEL RP-7 (K073710) | Intouch Technologies | 2008-04-11 |
| QHRV 1 - HEALTH ASSESSMENT SYSTEM (K080884) | Medtechs, LLC | 2008-04-11 |
| HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE (K072460) | Abbott Vascular, Inc. | 2008-04-11 |
| PHYSIOFLOW SYSTEM (K060387) | Vasocom, Inc. | 2008-04-10 |
| ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER (K080360) | Endologix, Inc. | 2008-04-08 |
| PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30 (K072583) | Maquet Cardiopulmonary, AG | 2008-04-04 |
| ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608 (K080806) | Possis Medical, Inc. | 2008-04-04 |
| BLOOD PRESSURE MONITOR, MODELS BP-102, BP-103, BP-201 AND BP-202 (K080789) | Sejoy Electronics & Instruments Co., Ltd. | 2008-04-03 |
| HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS) (K080192) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008-04-03 |
| CLEVER TD-3026 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL TD-3026 (K073445) | Taidoc Technology Corporation | 2008-04-02 |
| BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER (K073434) | Bipore, Inc. | 2008-04-01 |
| PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION (K073550) | Nihon Kohden America, Inc. | 2008-03-28 |
| QUICKCAT EXTRACTION CATHETER, MODEL 60090-01 (K073519) | Kensey Nash Corp. | 2008-03-28 |
| MODIFICATION TO: FOX PLUS PTA CATHETER (K080264) | Abbott Vascular-Vascular Solutions | 2008-03-26 |
| SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED (K072329) | Biotronik, Inc. | 2008-03-25 |
| DASH 2500 PATIENT MONITOR (K080157) | Ge Medical Systems Information Technologies | 2008-03-24 |
| SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 AND VS3 (K080495) | Philips Medical Systems | 2008-03-24 |
| CLARIVEIN CATHETER (K071468) | Vascular Insights, LLC | 2008-03-20 |
| ACUITY UNIVERSAL CUTTER (K080154) | Cardiac Pacemakers, Inc. | 2008-03-20 |
| RUNTHROUGH NS EXTENSION WIRE (K080563) | Terumo Medical Corp. | 2008-03-20 |
| SLIMMANAGER BODY COMPOSITION ANALYZER, MODELS N40 AND SM-300 (K073227) | Aiia Communication, Inc. | 2008-03-20 |