| RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER (K063609) | Shl Telemedicine International , Ltd. | 2007-09-12 |
| INTRAVASCULAR INTRODUCER SYSTEM (K063658) | Applied Medical Resources Corp. | 2007-09-12 |
| ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552 (K072269) | Possis Medical, Inc. | 2007-09-08 |
| EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM (K071348) | Mennen Medical , Ltd. | 2007-09-07 |
| PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521 (K071391) | Philips Medical Systems, Inc. | 2007-09-07 |
| CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR (K071911) | Innovision A/S | 2007-09-07 |
| HONEYWELL HOMMED CENTRAL STATION 4.0 (K072272) | Honeywell Hommed, LLC | 2007-09-07 |
| COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE (K072167) | Advanced Vascular Dynamics | 2007-09-06 |
| DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS (K071196) | Coeur, Inc. | 2007-09-06 |
| JOSTRA PEDIATRIC ARTERIAL PREFUSION CANNULAE (K072172) | Maquet Cardiopulmonary, AG | 2007-08-31 |
| BIOSIGN CENTRAL STATION (K071606) | Obs Medical | 2007-08-31 |
| MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921 (K071564) | Philips Medical Systems | 2007-08-31 |
| VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900 (K071660) | Volcano Corporation | 2007-08-31 |
| THE PORTABLE ANSISCOPE (K071168) | Dyansys, Inc. | 2007-08-31 |
| INNOVASA STAT*SEAL TOPICAL HEMOSTAT (K071225) | Innovasa, Inc. | 2007-08-31 |
| SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM (K070795) | Atcor Medical Pty, Ltd. | 2007-08-31 |
| PORTABLE ECSCOPE (K072353) | Dyansys Corp | 2007-08-30 |
| DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS (K071427) | Cardiovascular Systems, Inc. | 2007-08-30 |
| ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M (K072217) | Nihon Kohden America, Inc. | 2007-08-30 |
| VITALCOR FEATHERWEIGHT VASCULAR CLAMPS (K070661) | Vitalcor, Inc. | 2007-08-29 |
| FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05 (K071367) | LeMaitre Vascular, Inc. | 2007-08-29 |
| LIFESYNC ADAPTER, MODEL LS-302 (K071751) | Lifesync Corporation | 2007-08-27 |
| CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS) (K071029) | Stereotaxis, Inc. | 2007-08-24 |
| ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307 (K071336) | Possis Medical, Inc. | 2007-08-24 |
| THROMCAT THROMBECTOMY CATHETER SYSTEM (K072195) | Kensey Nash Corp. | 2007-08-23 |
| THERMOGARD XP THERMAL REGULATION SYSTEM (K072234) | Alsius Corp. | 2007-08-23 |
| MODIFIED MERCI RETRIEVER, MODEL 90060 (K071172) | Concentric Medical, Inc. | 2007-08-22 |
| REFLEXION SPIRAL VARIABLE RADIUS CATHETER (K072012) | St Jude Medical | 2007-08-22 |
| DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM (K071350) | Cardiovascular Systems, Inc. | 2007-08-22 |
| NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F (K070970) | Penumbra, Inc. | 2007-08-17 |
| REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES (K070036) | Ascent Healthcare Solutions | 2007-08-17 |
| M3 MONITOR (K072131) | Spectrum Medical , Ltd. | 2007-08-17 |
| QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V (K072060) | Nihon Kohden America, Inc. | 2007-08-17 |
| REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES (K070034) | Ascent Healthcare Solutions | 2007-08-17 |
| VENDYS MODEL 5000 B/BC (K060980) | Endothelix, Inc. | 2007-08-16 |
| KD-595 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K070828) | Kodon(Tianjin)Electronic&Electrical Apparatus Co., | 2007-08-15 |
| AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022 (K071699) | Aga Medical Corp. | 2007-08-15 |
| KD-795 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR (K070826) | Kodon(Tianjin)Electronic&Electrical Apparatus Co., | 2007-08-15 |
| PTFE FLIXENE GRADUATED WALL GRAFT (K071923) | Atrium Medical Corp. | 2007-08-14 |
| FINGERTIP PULSE OXIMETER MD300C (K070371) | Beijing Choice Electronic Technololgy Co., Ltd. | 2007-08-13 |
| TESLA NIBP (K062974) | Mammendorfer Institut Fur Physik Und Medizin GmbH | 2007-08-13 |
| PHILIPS MP2 AND X2 INTELLIVUE PATIENT MONITORS (K072070) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007-08-10 |
| MEMO 3D SEMIRIGID ANNULOPLASTY RING (K071327) | Sorin Biomedica Cardio S.R.L. | 2007-08-10 |
| ENDOWAVE INFUSION SYSTEM (K071933) | Ekos Corp. | 2007-08-10 |
| XTRACT CATHETER SYSTEM (K071529) | Lumen Biomedical, Inc. | 2007-08-10 |
| BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900 (K071884) | Jawon Medical Co., Ltd. | 2007-08-09 |
| RTX3370 (K071953) | Rtx Healthcare A/S | 2007-08-08 |
| FB-100U SERIES DIGITAL BLOOD PRESSURE MONITOR (K070209) | Fego Precision Industrial Co;, Ltd. | 2007-08-08 |
| DIGITAL PULSE OXIMETER, MODEL 7500FO (K071415) | Nonin Medical, Inc. | 2007-08-08 |
| EKOS MICRO-INFUSION SYSTEM (K063620) | Ekos Corp. | 2007-08-06 |
| MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000 (K071341) | Medivance, Inc. | 2007-08-03 |
| UNIRING - ANNULOPLASTY RING WITH SIZERS (K071281) | Peters Surgical | 2007-08-03 |
| MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05 (K071960) | Meditech Kft. | 2007-08-03 |
| BC (BODY COMPOSITION SOFTWARE) (K070999) | Rjl Systems, Inc. | 2007-08-02 |
| ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING (K071214) | Genesee Biomedical, Inc. | 2007-07-31 |
| ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 105039 (K071342) | Possis Medical, Inc. | 2007-07-31 |
| ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307 (K071514) | Possis Medical, Inc. | 2007-07-31 |
| DL900 SERIES HOLTER RECORDER (K071733) | Braemar, Inc. | 2007-07-24 |
| CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER (K071572) | Terumo Corp. | 2007-07-23 |
| SCOUTPRO SLITTER TOOL ADVANCED, MODEL 356 552 (K071665) | Biotronik, Inc. | 2007-07-18 |
| VR LUNG ELECTROSONOGRAPH (K061495) | Deep Breeze , Ltd. | 2007-07-18 |
| CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER (K071494) | Terumo Corp. | 2007-07-16 |
| BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM (K070500) | Ni Medical | 2007-07-16 |
| BLUE MAX BALLOON DILATATION CATHETER (K071309) | Boston Scientific Corp | 2007-07-13 |
| RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM (K070112) | Medcool, Inc. | 2007-07-13 |
| PC-60, NON-INVASIVEPULSE OXIMETER (K063641) | Shenzhen Creative Industry Co., Ltd. | 2007-07-13 |
| TRELLIS-6 PERIPHERAL INFUSION SYSTEM (K071664) | Bacchus Vascular, Inc. | 2007-07-13 |
| ASAHI ASTATO 30 PERIPHERAL GUIDE WIRE, MODELS - PAGH18M071, PAGH18M371 (K071721) | Asahi Intecc Co., Ltd. | 2007-07-13 |
| DIGITAL PULSE OXIMETER, MODEL 7500 (K071285) | Nonin Medical, Inc. | 2007-07-12 |
| CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15 (K071227) | Spectranetics Corp. | 2007-07-11 |
| M2 MONITOR (K071725) | Spectrum Medical , Ltd. | 2007-07-11 |
| HIGHPAK-12 (K062331) | Ad Elektronik GmbH | 2007-07-10 |
| BCI AUTOCON 3304 DIGITAL PULSE OXIMETER (K070732) | Smiths Medical Pm, Inc. | 2007-07-09 |
| MODIFICATION TO: STOCKERT S5 SYSTEM (K071318) | Sorin Group Deutschland GmbH | 2007-07-06 |
| STIFFER COAXIAL MICRO-INTRODUCER KIT (K071574) | Enpath Medical, Inc. | 2007-07-05 |
| AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014 (K071253) | Medtronic Vascular | 2007-07-03 |
| MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S (K071645) | Omron Healthcare, Inc. | 2007-07-02 |
| Z6 STIMULATOR (K070743) | St Cardio Technologies, LLC | 2007-07-02 |
| 8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043 (K071226) | Spectranetics Corp. | 2007-06-29 |
| MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS (K071024) | Masimo Corporation | 2007-06-29 |
| MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A (K071058) | Nihon Kohden America, Inc. | 2007-06-29 |
| GORE BALLOON SHEATH (K070770) | W. L. Gore & Associates, Inc. | 2007-06-29 |
| ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F (K071234) | Siemens Medical Solutions USA, Inc. | 2007-06-29 |
| PALM ECG RECORDER, MODEL EP-201/202 (K061123) | Parama-Tech Company., Ltd. | 2007-06-29 |
| MEDICK MHM200 PERSONAL HEART MONITOR (K063339) | Medick Healthcare , Ltd. | 2007-06-29 |
| FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODELS BP1600, BP1650, BP1700 AND BP1750 (K071523) | Genexel-Sein, Inc. | 2007-06-26 |
| PM SERIES PATIENT MONITORS, MODELS PM-9000 EXPRESS AND PM-8000 EXPRESS (K070791) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007-06-26 |
| ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO (K071025) | Zoll Medical Corporation, World Wide Headquarters | 2007-06-22 |
| PRELUDE SHEATH INTRODUCER (K070159) | Merit Medical Systems, Inc. | 2007-06-21 |
| AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016 (K071125) | Aga Medical Corp. | 2007-06-18 |
| DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU05 AND L-CICU05A SOFTWARE (K071020) | GE Healthcare | 2007-06-18 |
| POLARCATH PERIPHERAL DILATATION SYSTEM (K071042) | Boston Scientific Corp | 2007-06-13 |
| MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, AND MP90 INTELLIVUE PATIENT MONITORS (K071426) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007-06-13 |
| STRIDE MICROCATHETER (K062885) | Asahi Intecc Co., Ltd. | 2007-06-13 |
| PRONTO .035 EXTRACTION CATHETER (K070403) | Vascular Solutions, Inc. | 2007-06-13 |
| PORTACLAMP FLEX (K070380) | Cardio Life Research, S.A. | 2007-06-08 |
| MASIMO PATIENT SAFETY NET (K071047) | Masimo Corporation | 2007-06-08 |
| KD-525E FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K070395) | Kodon(Tianjin)Electronic&Electrical Apparatus Co., | 2007-06-07 |
| HEALTH CHECK KIOSK (K063008) | Xperex Corporation | 2007-06-07 |
| ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984 (K070417) | St Jude Medical | 2007-06-05 |