| MORTARA ELI 350 ELECTROCARDIOGRAPH (K082946) | Mortara Instrument, Inc. | 2008-12-29 |
| IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS (K083347) | Fluke Biomedical | 2008-12-24 |
| LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES (K083091) | Biocompatibles UK Limited | 2008-12-24 |
| BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY (K083271) | Nihon Kohden America, Inc. | 2008-12-24 |
| CONQUEST PTA BALLOON DILATATION CATHETER (K083657) | C.R. Bard, Inc. | 2008-12-24 |
| COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES (K081768) | Cook Incorporated | 2008-12-23 |
| VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES (K082630) | Zefon Intl. | 2008-12-19 |
| X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS (K083301) | Terumo Cardiovascular Systems Corp. | 2008-12-18 |
| STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO) (K082344) | Sorin Group Deutschland GmbH | 2008-12-17 |
| TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205 (K081498) | Biocomfort Diagnostics GmbH & Co. KG | 2008-12-17 |
| HEARTSUITE HEMODYNAMICS 7.10 (K082421) | Emageon, Inc. | 2008-12-17 |
| BARD PTFE (TEFLON) COATED GUIDE WIRES (K082094) | C.R. Bard Inc., Bard Electrophysiology Division | 2008-12-17 |
| CHEETAH RELIANT (K083093) | Cheetah Medical, Inc. | 2008-12-15 |
| EMBOZENE MICROSPHERES (K073417) | Celonova Biosciences, Inc. | 2008-12-15 |
| MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM (K083335) | Omnisonics Medical Technologies | 2008-12-15 |
| SEDAT FLAMINGO (K082755) | Sedat | 2008-12-15 |
| AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323 (K083402) | St Jude Medical | 2008-12-15 |
| HEARTRAK SMART ECAT (K083535) | Universal Medical, Inc. | 2008-12-15 |
| D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006 (K083370) | Artegraft, Inc. | 2008-12-12 |
| 9131 DEFIBRILLATION ELECTRODES (K082090) | Cardiac Science Corporation | 2008-12-12 |
| CPS AIM SL SLITTABLE INNER CATHETER (K082932) | St Jude Medical | 2008-12-12 |
| ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 (K082382) | Possis Medical, Inc. | 2008-12-12 |
| TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11 (K081852) | Truly Instrument Limited | 2008-12-12 |
| CHAPERON GUIDING CATHETER (K082385) | MicroVention, Inc. | 2008-12-11 |
| SPECTRANETICS CROSS-PILOT TURBO ELITE SUPPORT CATHETER (K082559) | Spectranetics Corp. | 2008-12-11 |
| BIONET BM3PLUS PATIENT MONITOR (K082008) | Bionet Co., Ltd. | 2008-12-11 |
| SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS (K082561) | Spectranetics Corp. | 2008-12-10 |
| FREEWAY AND RAILRUNNER GUIDEWIRES (K082922) | Lake Region Mfg., Inc. | 2008-12-09 |
| AGILIS NXT STEERABLE INTRODUCER, MODEL G408324 (K081645) | St Jude Medical | 2008-12-09 |
| MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR (K082308) | Edwards Lifesciences, LLC | 2008-12-09 |
| ZOLL R SERIES BLS DEFIBRILLATOR (K081828) | ZOLL Medical Corporation | 2008-12-09 |
| ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY (K080428) | Medtronic, Inc. | 2008-12-09 |
| SPECTRA GUIDEWIRE INTRODUCER NEEDLE (K082580) | Spectra Medical Devices, Inc. | 2008-12-08 |
| THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006 (K081697) | Access Scientific, Inc. | 2008-12-04 |
| MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET (K082670) | Medtronic, Inc. | 2008-12-04 |
| NANOCORSS .014 OTW PTA DILATATION CATHETER (K082854) | Ev3, Inc. | 2008-12-04 |
| ZOLL E SERIES WITH INTIBATION ASSIST OPTION (K080903) | ZOLL Medical Corporation | 2008-12-04 |
| HEADWAY 17 MICROCATHETER (K083343) | MicroVention, Inc. | 2008-12-04 |
| VISION WIRE CORONARY GUIDEWIRE (K082935) | Biotronik, Inc. | 2008-12-04 |
| VICARDIO 12B (K082380) | Energy-Lab Technologies GmbH | 2008-12-03 |
| REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT FINGER CLIP SENSOR, PHILLIPS ADULT SOFT TIP SENSOR(U403S-91) (K082546) | Unimed Medical Supplies, Inc. | 2008-12-02 |
| MODIFICATION TO INTEL HEALTH GUIDE, MODEL PHS6000 (K083115) | Intel Corp. | 2008-11-26 |
| CARDIO-VIEW (K083321) | Curlview Igt, LLC | 2008-11-26 |
| NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES (K082785) | Nihon Kohden America, Inc. | 2008-11-26 |
| QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200 (K083078) | Quanta Computer, Inc. | 2008-11-26 |
| INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997 (K082888) | Draeger Medical Systems, Inc. | 2008-11-26 |
| LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE (K083340) | Levitronix, LLC | 2008-11-26 |
| VIPERSPHERE PTA BALLOON CATHETER (K083139) | Cardiovascular Systems, Inc. | 2008-11-25 |
| BODYSTAT 1500 BODY COMPOSITION MONITORING UNIT (K082253) | Bodystat , Ltd. | 2008-11-25 |
| AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561 (K082861) | Amco International Manufacturing & Design, Inc. | 2008-11-25 |
| PHILIPS INTELLIVUE MP5 PATIENT MONITOR (K083228) | Philips Medizin Systeme Boblingen GmbH | 2008-11-24 |
| MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP O3 (K082881) | Microlife Intellectual Property GmbH | 2008-11-24 |
| ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000 (K083146) | Asahi Intecc Co., Ltd. | 2008-11-21 |
| NEURON SELECT CATHETER SIZE 070 (K083125) | Penumbra, Inc. | 2008-11-21 |
| EVERCROSS .035 OTW PTA DILATATION CATHETER (K082579) | Ev3, Inc. | 2008-11-20 |
| ENABLER-P SUPPORT CATHETER (K082339) | Endocross, Ltd. | 2008-11-20 |
| MULTLINK CABLE AND LEADWIRE SYSTEM (K082851) | Ge Medical Systems Information Technologies | 2008-11-19 |
| AVALON ELITE VASCULAR ACCESS KIT (K081940) | Avalon Laboratories, LLC | 2008-11-18 |
| FIBERNET EMBOLIC PROTECTION SYSTEM (K082348) | Lumen Biomedical, Inc. | 2008-11-18 |
| SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE (K081986) | Oscor, Inc. | 2008-11-14 |
| A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR (K082734) | A&D Engineering, Inc. | 2008-11-13 |
| VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160 (K082412) | Mapquet Cardiopulmonary AG | 2008-11-10 |
| FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL (K082641) | Contec Medical System Co., Ltd. | 2008-11-10 |
| CLUE MEDICAL AND CLUE MEDICAL BASIC (K082013) | Telovital GmbH Telemedizin | 2008-11-10 |
| TELECTRODE WET GEL ECG ELECTRODE (K083148) | Bio Protech, Inc. | 2008-11-07 |
| REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528 (K082475) | Medtronic, Inc. | 2008-11-07 |
| AGILIS NXT STEERABLE INTRODUCER (K083083) | St Jude Medical | 2008-11-06 |
| OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER (K082646) | Usci Ireland | 2008-11-03 |
| PASSEO-35 PTA CATHETER (K082933) | Biotronik, Inc. | 2008-11-03 |
| DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT (K082981) | Cardiovascular Systems, Inc. | 2008-10-31 |
| MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002 (K083135) | Thermogear, Inc. | 2008-10-31 |
| NEURON DELIVERY CATHETER 070 (K082290) | Penumbra, Inc. | 2008-10-31 |
| BP LIMBO XL, BPTANGO XL, BP SALSA XL (K072752) | Datadancer Medical Systems | 2008-10-31 |
| G2 EXPRESS FILTER SYSTEM - FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS (K082305) | C.R. Bard, Inc. | 2008-10-31 |
| MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODELWATCHBP OFFICE (TWIN200). (K082357) | Microlife Intellectual Property GmbH | 2008-10-29 |
| PINNACLE ROII INTRODUCER SHEATH (K082847) | Terumo Medical Corp. | 2008-10-29 |
| FLOWMEDICA BENEPHIT INFUSION SYSTEMS (K082163) | Flowmedica, Inc. | 2008-10-29 |
| APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR (K083021) | Sorin Group Italia S.R.L. | 2008-10-29 |
| VTI INTRAOPERATIVE DOPPLER SYSTEMS (K082870) | Vascular Technology Incorporated | 2008-10-28 |
| KING`YIELD WRIST BLOOD PRESSURE MONITOR, MODEL BP201 (K083043) | Shenzhen Kingyield Technology Co., Ltd. | 2008-10-27 |
| MULLINS-X, MODEL 250X (K082868) | NuMED, Inc. | 2008-10-24 |
| KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530 (K081587) | Krell Precision (Yang Zhou) Co., Ltd. | 2008-10-24 |
| EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700 (K082139) | Edwards Lifesciences, LLC | 2008-10-23 |
| OMRON MODEL HBP-2070 VITAL SIGNS MONITOR (K082812) | Omron Healthcare, Inc. | 2008-10-22 |
| HYPERQ SYSTEM (K082564) | Biological Signal Processing, Ltd. | 2008-10-20 |
| DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100 (K080854) | Suntech Medical, Inc. | 2008-10-20 |
| NON-INVASIVE CONTINUOUS BLOOD PRESSURE MONITORING SYSTEM CNAP MONITOR 500I, 500AT (K082599) | Cnsystem Medizintechnik AG | 2008-10-17 |
| SPIRALFUSE PERIPHERAL INFUSION SYSTEM (K082199) | Bacchus Vascular, Inc. | 2008-10-17 |
| INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM (K080908) | Innercool Therapies, Inc.- A Delaware Corporation | 2008-10-17 |
| MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT (K081438) | Lifenet Health | 2008-10-17 |
| VRIICU SYSTEM (K073582) | Deep Breeze , Ltd. | 2008-10-15 |
| FLOWPICC CONSOLE (K081626) | Vasonova, Inc. | 2008-10-15 |
| PRELUDE SHORT SHEATH INTRODUCER (K082063) | Merit Medical Systems, Inc. | 2008-10-15 |
| PHILIPS MP5 AND MP5T INTELLIVUE PATIENT MONITORS AND TRX4841A INTELLIVUE TELEMETRY SYSTEM TRANSCEIVER (K081793) | Philips Medizin Systeme Boeblingen GmbH | 2008-10-14 |
| HEM-9000AI (K081654) | Omron Healthcare, Inc. | 2008-10-10 |
| MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECK (K082052) | Masimo Corporation | 2008-10-10 |
| PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS (K082959) | Unimed Medical Supplies, Inc. | 2008-10-10 |
| TEMPUSIC PATIENT MONITOR (K082718) | Remote Diagnostic Technologies , Ltd. | 2008-10-10 |
| OXISCAN II DATA MANAGEMENT SYSTEM (K080348) | Airsep Corp. | 2008-10-09 |
| BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001 (K081187) | Bridgepoint Medical | 2008-10-08 |