| AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 (K072527) | Zoll Circulation | 2008-03-19 |
| ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM (K072864) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2008-03-13 |
| MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R (K073324) | Medtronic, Inc. | 2008-03-13 |
| STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0 (K080461) | Philips Medical Systems | 2008-03-13 |
| MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7 (K080500) | Acumen Medical, Inc. | 2008-03-13 |
| LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109 (K073260) | Device Partners International | 2008-03-13 |
| VENOWAVE MODELS VW5-6, VW5-10, VW5-20 AND VW5-30 (K073028) | Venowave, Inc. | 2008-03-07 |
| CONVOY ADVANCED DELIVERY SHEATH (K072719) | Boston Scientific Corp | 2008-03-07 |
| COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET (K073374) | William Cook Europe Aps | 2008-03-07 |
| AMADEUS ADAPTIVE COMPRESSION THERAPY (K071763) | Convatec | 2008-03-07 |
| DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH (K080415) | Terumo Medical Corp. | 2008-03-07 |
| PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA FOAM EMBOLIZATION PARTICLES (K073544) | Rj Medical, Inc. | 2008-03-05 |
| MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF (K071244) | Medline Industries, Inc. | 2008-03-05 |
| CAPIOX CIRCUIT CONNECTORS (K073474) | Terumo Corp. | 2008-03-05 |
| FLEXOR EVAC ASPIRATION CATHETER (K073627) | Cook, Inc. | 2008-03-04 |
| SYNTHESIS PH.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARETERIAL FILTER AND HARDSHELL VENOUS/CARIOTOMY RESERVOI (K073380) | Sorin Group Italia S.R.L. | 2008-02-29 |
| HEART SYNC, MODELS C-100 AND T-100 (K080421) | Heart Sync, LLC | 2008-02-29 |
| PACIFICA (K073407) | Or-Nim Medical , Ltd. | 2008-02-28 |
| GUARDIAN HEMOSTASIS VALVE (K073620) | Zerusa Limited | 2008-02-27 |
| VENA CAVA FILTER (K073528) | Cook Incorporated | 2008-02-27 |
| 1500 PRO (K080289) | Omron Healthcare, Inc. | 2008-02-26 |
| MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM (K080206) | Radi Medical Systems AB | 2008-02-26 |
| PHILIPS HEARTSTART SMARTPADS III (K072812) | Philips Medical Systems | 2008-02-26 |
| MANDREL GUIDEWIRES OR M-WIRES (K080144) | Lake Region Mfg., Inc. | 2008-02-26 |
| NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES (K080342) | Nihon Kohden America, Inc. | 2008-02-26 |
| YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-100J, BP-110J; DIGITAL WRIST BLOOD PRESSURE MONITOR, BP-500,BP-500 (K072860) | Ya Horng Electronic Co., Ltd. | 2008-02-25 |
| FORE-SIGHT, MC-2000 SERIES (K073036) | Cas Medical Systems, Inc. | 2008-02-25 |
| THUMPER, MODEL: 1008 (K073079) | Michigan Instruments, Inc. | 2008-02-14 |
| SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE (K071432) | Fox Hollow Technologies | 2008-02-12 |
| MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES (K073024) | Masimo Corporation | 2008-02-08 |
| SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING (K073162) | Kensey Nash Corporation | 2008-02-08 |
| SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS (K072947) | ClearStream Technologies , Ltd. | 2008-02-08 |
| OCCLUSION BALLOON CATHETER (K070126) | Sentreheart, Inc. | 2008-02-08 |
| HEARTSTRING III PROXIMAL SEAL SYSTEM (K080169) | Guidant Corporation, Cardiac Surgery | 2008-02-08 |
| STAR 55 (K080173) | Larsen & Toubro Limited | 2008-02-08 |
| MODIFICATION TO:HEALTH BUDDY APPLIANCE (K080091) | Health Hero Network, Inc. | 2008-02-05 |
| GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582 (K073200) | Vascular Solutions, Inc. | 2008-02-01 |
| SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE (K080106) | Leonhard Lang GmbH | 2008-02-01 |
| AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC (K070985) | Osypka Medical, Inc. | 2008-02-01 |
| VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER (K072798) | Abbott Vascular-Vascular Solutions | 2008-01-31 |
| 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II (K073559) | Edwards Lifesciences Research Medical | 2008-01-31 |
| MODIFICATION TO PROXIS SYSTEM (K073563) | St Jude Medical | 2008-01-31 |
| HERO VASCULAR ACCESS DEVICE (K071778) | Graftcath, Inc. | 2008-01-30 |
| ALN OPTIONAL VENA CAVA FILTER-FEMORAL APPROACH, JUGULAR APPROACH, BRACHIAL APPROACH, EXTRACTION KIT, PRECURVED EXTRACTIO (K070514) | Aln Implants Chirurgicaux | 2008-01-30 |
| IMPULSE 6000D/7000DP (K072114) | Fluke Biomedical | 2008-01-28 |
| PEGASUS STEERABLE (PTCA) GUIDEWIRE (K073655) | Lake Region Mfg., Inc. | 2008-01-28 |
| MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM (K073625) | Ge Healthcare Systems Information Technologies | 2008-01-25 |
| OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM (K073656) | Hypermed, Inc. | 2008-01-25 |
| LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500 (K072596) | Amco International Manufacturing & Design, Inc. | 2008-01-24 |
| ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 (K073441) | Possis Medical, Inc. | 2008-01-24 |
| JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE-HMOD 2000, BEQ-HMOD 2030 (K071774) | Maquet Cardiopulmonary, AG | 2008-01-23 |
| I-PAD (K062970) | Cu Medical Systems, Inc. | 2008-01-22 |
| TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) (K072770) | Oscor, Inc. | 2008-01-22 |
| NICOM ELECTRODES (K071631) | Cheetah Medical, Inc. | 2008-01-18 |
| CHEETAH RELIANT, CHEETAH ACTIVE (K072662) | Cheetah Medical, Inc. | 2008-01-16 |
| PORTABLE ECSCOPE 12I (K080036) | Dyansys, Inc. | 2008-01-16 |
| BIPORE BALLOON DILATION CATHETER (K073318) | Bipore, Inc. | 2008-01-16 |
| RECOVERY G2 FILTER SYSTEM - FEMORAL DELIVERY KIT, MODEL RF-310F; JUGULAR/SUBCLAVAIN DELIVERY KIT, MODEL RF-320J (K073090) | C.R. Bard, Inc. | 2008-01-15 |
| FINGERTIP PULSE OXIMETER, MODEL MD300I (K072825) | Beijing Choice Electronic Technololgy Co., Ltd. | 2008-01-14 |
| EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING CATHETER, MODEL 85700 (K073473) | Volcano Corporation | 2008-01-14 |
| HYDROCOIL EMBOLIC SYSTEMS (HES) (K071939) | MicroVention, Inc. | 2008-01-11 |
| MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP HOME (BP3MX1-1) (K073198) | Microlife Intellectual Property GmbH | 2008-01-11 |
| MICROSHEATH XL CATHETERS (K073289) | Flowcardia, Inc. | 2008-01-11 |
| MODIFICATION TO: BPCARD, MODEL Z-7000-0700 (K073630) | Qrs Diagnostic, LLC | 2008-01-11 |
| MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES (K073462) | Ge Medical Systems Information Technologies | 2008-01-11 |
| CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B (K073038) | Carematix, Inc. | 2008-01-11 |
| HEARTEVENT, MODEL AT (K072385) | Diagnostic Devices Pty, Ltd. | 2008-01-11 |
| PC-180 / PRINCE 180 EASY ECG MONITOR (K073152) | Shenzhen Creative Industry Co., Ltd. | 2008-01-10 |
| CPS COURIER GUIDEWIRE (K073082) | Brivant, Ltd. | 2008-01-09 |
| SIBEL SA VASCULAR CLAMP (K072834) | Surgical Instruments Belgium SA | 2008-01-09 |
| ASAHI PTCA GUIDE WIRE (K070945) | Asahi Intecc Co., Ltd. | 2008-01-09 |
| VACCESS PTA BALLOON DILATATION CATHETER (K073472) | C.R. Bard, Inc. | 2008-01-09 |
| PM-60 PULSE OXIMETER (K072581) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008-01-08 |
| VITALLINK3 MOBILE VITAL SIGNS SYSTEM (K073094) | Telemedic Systems, Ltd. | 2008-01-04 |
| Y-GLIDE (K072745) | Thomas Medical Products, Inc. | 2008-01-04 |
| VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM (K071554) | Volcano Corporation | 2008-01-04 |
| JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING (K070605) | Maquet Cardiopulmonary, AG | 2008-01-04 |
| INFINITY PICCO POD, MODEL MS16734 (K073113) | Draeger Medical Systems, Inc. | 2008-01-03 |
| PENUMBRA SYSTEM (K072718) | Penumbra, Inc. | 2007-12-28 |
| ADVANCE 18LP PTA DILATATION CATHETER (K073378) | Cook, Inc. | 2007-12-28 |
| FLEXCATH STEERABLE SHEATH & DILATOR (K070357) | Cryocath Technologies, Inc. | 2007-12-28 |
| MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T (K072886) | Medrad, Inc. | 2007-12-21 |
| MICROLIFE UPPER ARM MANUAL BLOOD PRESSURE MONITOR, MODEL BP3MR1-H (BP A50) (K073397) | Microlife Corp. | 2007-12-20 |
| MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3MK1-3 (BP W100) (K073398) | Microlife Corp. | 2007-12-20 |
| VARICATH PERIPHERAL INFUSION CATHETER (K073400) | Veinrx, Inc. | 2007-12-20 |
| 3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES (K072697) | 3t Medical Systems, LLC | 2007-12-20 |
| MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS (K073230) | Biotronik, Inc. | 2007-12-20 |
| STUDIODOP VICORDER (K071730) | Skidmore Medical, Limited | 2007-12-20 |
| ANTIMICROBIAL AND SINGLE-PATIENT CUFFS (K071885) | Philips Medical Systems | 2007-12-20 |
| ENSITE FUSION DYNAMIC REGISTRATION TOOL (K071818) | St Jude Medical | 2007-12-20 |
| PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010 (K072810) | Vascular Solutions, Inc. | 2007-12-19 |
| DUAL SHOT ALPHA (K071691) | Nemoto Kyorindo Co., Ltd. | 2007-12-19 |
| WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE) (K070060) | Welch Allyn, Inc. | 2007-12-18 |
| MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044 (K072796) | Concentric Medical, Inc. | 2007-12-18 |
| CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR (K071995) | Card Guard Scientific Survival , Ltd. | 2007-12-18 |
| MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE (K072552) | Merit Medical Systems, Inc. | 2007-12-14 |
| SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE (K070225) | Abiomed, Inc. | 2007-12-13 |
| PASSEO 18 (K072765) | Biotronik, Inc. | 2007-12-12 |
| THE CROSSER SYSTEM (K072776) | Flowcardia, Inc. | 2007-12-07 |
| AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZB (K072137) | Avita Corporation | 2007-12-07 |