| LIFE+CEL BATTERY (K071164) | Amco International Manufacturing & Design, Inc. | 2007-12-07 |
| ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI) (K073372) | Systemsone | 2007-12-07 |
| DM-EMG (K072513) | Gvp Elettronica Srl | 2007-12-07 |
| CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005 (K072558) | Cardionet, Inc. | 2007-12-05 |
| SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066 (K072750) | Spectranetics Corp. | 2007-12-04 |
| SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08 (K073147) | Transoma Medical | 2007-12-03 |
| INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S (K073100) | Oscor, Inc. | 2007-11-30 |
| BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205 (K072325) | Jawon Medical Co., Ltd. | 2007-11-30 |
| CONTINUOUS NON-INVASIVE CARDIAC OUTPUT AND BLOOD PRESSURE MONITOR WITH REAL-TIME HEMODYNAMICS (K072049) | Bmeye B.V. | 2007-11-29 |
| RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25 (K072194) | Renu Medical, Inc. | 2007-11-29 |
| SA-3000P (K073323) | Medicore Co., Ltd. | 2007-11-29 |
| MOBIL-O-GRAPH NG 24 H ABP-CONTROL (K072446) | I.E.M. GmbH | 2007-11-29 |
| PM-7000 PATIENT MONITOR (K072346) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007-11-29 |
| CARESCAPE V100 (K073203) | Ge Medical Systems Information Technologies | 2007-11-29 |
| CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS (K072449) | Welch Allyn, Inc. | 2007-11-29 |
| REVEAL XT; INSERTABLE CARDIAC MONITOR (MODEL 9529), PATIENT ASSISTANT (MODEL 9539) (K071641) | Medtronic, Inc. | 2007-11-21 |
| PADNET+ (K073146) | Biomedix, Inc. | 2007-11-21 |
| VITALOGIK MODEL 4000/4500 (K073140) | Mennen Medical , Ltd. | 2007-11-21 |
| TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM (K071521) | Terumo Cardiovascular Systems Corp. | 2007-11-21 |
| TWIN-PASS OTW CATHETER, MODEL 5201 (K072618) | Vascular Solutions, Inc. | 2007-11-21 |
| PHLEBOPRESS MODEL 601A COMPRESSION THERAPY DEVICE (K072372) | Mego Afek | 2007-11-21 |
| CTU676 DEVICE (K073013) | Compression Technologies Unlimited, Inc. | 2007-11-21 |
| FIDELITY 200 CARDIAC EVENT RECORDER (K071228) | Signalife, Inc. | 2007-11-21 |
| REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538 (K071655) | Medtronic, Inc. | 2007-11-21 |
| PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS (K073035) | Merit Medical Systems, Inc. | 2007-11-20 |
| HEMOSTASIS VALVE (K072556) | Merit Medical Systems, Inc. | 2007-11-20 |
| CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01) (K072202) | Biosense Webster, Inc. | 2007-11-19 |
| MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM (K072502) | Ge Medical Systems Information Technologies | 2007-11-19 |
| SKINTACT AND VARIOUS OTHER TRADENAMES (K073104) | Leonhard Lang GmbH | 2007-11-16 |
| CONFIDANT 2.5 (K072698) | Confidant, Inc. | 2007-11-16 |
| A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE (K072593) | Healthstats International Pte. , Ltd. | 2007-11-15 |
| ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS (K072769) | Possis Medical, Inc. | 2007-11-14 |
| ODYSSEY WORKSTATION (K072371) | Stereotaxis, Inc. | 2007-11-14 |
| THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910 (K071826) | Fox Hollow Technologies | 2007-11-09 |
| VASCUTRAK II PTA DILATATION CATHETER (K073025) | Thermopeutix, Inc. Dba Ymed, Inc. | 2007-11-09 |
| CXI SUPPORT CATHETER (K072724) | Cook, Inc. | 2007-11-09 |
| MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM (K072748) | Cardiovascular Systems, Inc. | 2007-11-09 |
| OPTIMUS 0.035 INCH PTA BALLOON DILATATION CATHETER (K072156) | Usci Ireland | 2007-11-09 |
| VIAPEEL PEELABLE INTRODUCER (K072248) | Enpath Medical, Inc. | 2007-11-09 |
| TESLA GUARD, MODEL EFT G04 (K071802) | Mammendorfer Institut Fur Physik Und Medizin GmbH | 2007-11-09 |
| CHILLBUSTER PORTABLE ELECTRIC BLANKET, MODEL 8002 (K071918) | Thermogear, Inc. | 2007-11-09 |
| GUNTHER TULIP VENA CAVA FILTER (K072240) | Cook, Inc. | 2007-11-08 |
| AUSCO ES-3100 (K070550) | Koratek Company, Ltd. | 2007-11-06 |
| ZOLL PEDIPADZ REDUCED ENERGY ELECTRODE (K072430) | ZOLL Medical Corporation | 2007-11-06 |
| MEDIAID PULSE OXIMETER M30 AND M34 (K071610) | Mediaid, Inc. | 2007-11-05 |
| BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM (K072666) | Bio Compression Systems, Inc. | 2007-11-05 |
| AMPLATZER TORQVUE DELIVERY SYSTEM (K072313) | Aga Medical Corp. | 2007-11-02 |
| VENDYS, MODEL 6000 B B/C (K072919) | Endothelix, Inc. | 2007-11-02 |
| TEXTRONICS ECG ELECTRODE (K071576) | Textronics, Inc. | 2007-11-02 |
| GALTSTICK INTRODUCER SYSTEM (K071330) | Galt Medical Corp. | 2007-10-31 |
| GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID (K072990) | Medtronic, Inc. | 2007-10-31 |
| PTFE PEEL AWAY MICROINTRODUCER (K072130) | Intromed | 2007-10-31 |
| D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR (K072091) | Sorin Group Italia S.R.L. | 2007-10-29 |
| STIMLAB (K072200) | Micropace Pty, Ltd. | 2007-10-26 |
| RNK ELECTRONIC STETHOSCOPE (K072026) | Rnk Products, Inc. | 2007-10-26 |
| DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM (K072800) | Cardiovascular Systems, Inc. | 2007-10-25 |
| ESTECH PERCUTANEOUS INSERTION DILATOR KIT (K070749) | Coombs Medical Device Consulting | 2007-10-24 |
| FOX SV PTA CATHETER (K072824) | Abbott Laboratories | 2007-10-23 |
| ASAHI PTCA GUIDE WIRE, FIELDER FC J, MODELS: AGP140001J, AGP140301J (K072705) | Asahi Intecc Co., Ltd. | 2007-10-23 |
| ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR (K072655) | Genesee Biomedical, Inc. | 2007-10-23 |
| EXPANDING VASCULAR SHEATH (K070865) | Applied Medical | 2007-10-23 |
| NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG (K072362) | Novalung GmbH | 2007-10-23 |
| PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR (K072235) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007-10-19 |
| MIDMARK DIAGNOSTICS IQMARK VITAL SIGNS MONITOR (K072516) | Midmark Diagnostics Group | 2007-10-18 |
| PULSION PICCO-2, MODEL 8500 (K072735) | Pulsion Medical Systems AG | 2007-10-18 |
| ANGIOSCULPT PTA SCORING BALLOON CATHETER (K072225) | Angioscore, Inc. | 2007-10-12 |
| CITOP10 GUIDEWIRE, 0.014(1.4MM TIP), CITOP6 GUIDEWIRE, 0.014(1.0MM TIP), CITOP SUPPORT ACCESSORY, 0.023(126CM) (K070212) | Ovalum , Ltd. | 2007-10-12 |
| CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE (K072295) | Oridion Capnography, Inc. | 2007-10-11 |
| MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901 (K071384) | Nihon Seimitsu Sokki Co., Ltd. | 2007-10-09 |
| SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS (K072233) | Leonhard Lang GmbH | 2007-10-05 |
| MICRUS COURIER ENZO MICROCATHETER 0.0190 (K072526) | Micrus Endovascular Corporation | 2007-10-05 |
| PIONEER CATHETER (K072155) | Medtronic, Inc. | 2007-10-05 |
| ENDOWAVE INFUSION SYSTEM (K072507) | Ekos Corp. | 2007-10-04 |
| ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS (K070798) | Coeur, Inc. | 2007-10-04 |
| RADIUS SNARE (K070502) | Radius Medical Technologies, Inc. | 2007-10-04 |
| E3-80 PORTABLE ECG RECORDER & ANALYZER (K071085) | Micro-Star International Co., Ltd. | 2007-10-03 |
| NOVATOME, MODEL: SU101-50 (K072051) | Scholten Surgical Instruments, Inc. | 2007-10-03 |
| BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER (K072008) | Braemar, Inc. | 2007-10-03 |
| SLEUTH IMPLANTABLE ECG MONITORING SYSTEM (K063035) | Transnoma Medical, Inc. | 2007-10-01 |
| QXT EXTRACTION CATHETER (K071727) | Vascular Solutions, Inc. | 2007-09-28 |
| OMNIWAVE ENDOVASCULAR SYSTEM (K071762) | Omnisonics Medical Technologies | 2007-09-27 |
| ASAHI PTCA GUIDE WIRE, X-TREME (K072431) | Asahi Intecc Co., Ltd. | 2007-09-26 |
| BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100 (K070156) | Cardiodynamics International Corp. | 2007-09-26 |
| AVIAFIT PULSATING LEGBAND (K071744) | Flowmedic , Ltd. | 2007-09-25 |
| NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX (K071805) | Datascope Corp. | 2007-09-25 |
| MODIFICATION TO RADIUS SNARE (K071457) | Radius Medical Technologies, Inc. | 2007-09-25 |
| MODIFICATION TO: UNITY NETWORK ID (K071982) | Ge Medical Systems Information Technologies | 2007-09-21 |
| PLANET 55 (K071472) | Larsen & Toubro Limited | 2007-09-21 |
| PULL TAB SQUEEZE FLUSH (K070979) | Icu Medical, Inc. | 2007-09-19 |
| PERIPHERAL GUIDING SHEATH (K070816) | Micrus Design Technology, Inc. | 2007-09-19 |
| DORADO PTA BALLOON DILATATION CATHETER (K072283) | Bard Peripheral Vascular, Inc. | 2007-09-19 |
| PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112 (K063735) | Presym, Inc. | 2007-09-19 |
| PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES (K072364) | Pulsion Medical Systems AG | 2007-09-19 |
| MODIFICATION TO HYPERQ SYSTEM (K072389) | Biological Signal Processing, Ltd. | 2007-09-18 |
| PRECIOUS PLUS GUIDE CATHETER (K072316) | Asahi Intecc Co., Ltd. | 2007-09-17 |
| BRK TRANSSEPTAL NEEDLE (K072278) | St Jude Medical | 2007-09-13 |
| SENTEC DIGITAL MONITORING SYSTEM (K071672) | Sentec AG | 2007-09-12 |
| BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM (K072297) | Cardiva Medical, Inc. | 2007-09-12 |
| POCKETCPR (K071321) | Bio-Detek, Inc. | 2007-09-12 |
| D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED (K072308) | Sorin Group Italia S.R.L. | 2007-09-12 |