| PULSE OXIMETER MODEL P10 (K100225) | Mediana Co., Ltd. | 2011-02-09 |
| SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES (K103186) | Leonhard Lang GmbH | 2011-02-08 |
| INTEL HEALTH GUIDE (K103276) | Intel Corporation Digital Health Group | 2011-02-08 |
| DEFIBRILLATOR ANALYZER - DA-2006P (K110192) | Bc Group International, Inc. | 2011-02-08 |
| MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT (K082254) | Bodystat , Ltd. | 2011-02-07 |
| QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT (K082255) | Bodystat , Ltd. | 2011-02-07 |
| AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0 (K103516) | Inovise Medical, Inc. | 2011-02-04 |
| SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR (K103732) | Spacelabs Healthcare, Ltd. | 2011-02-04 |
| BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM (K110104) | Cincinnati Sub-Zero Products, Inc. | 2011-02-04 |
| MH1 MICROHOLTER RECORDER (K101969) | Exelys, LLC | 2011-02-04 |
| VASCULAIRE COMPRESSION SYSTEM (K103113) | Venous Health Systems, Inc. | 2011-02-02 |
| ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE (K110009) | Cook, Inc. | 2011-02-02 |
| ARSTASIS ONE LATCHWIRE ACCESS SYSTEM (K103143) | Arstasis, Inc. | 2011-02-02 |
| CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES (K103347) | Intervascular Sas | 2011-02-02 |
| ANS SYSTEM (K101016) | Caird Technology | 2011-01-28 |
| 4D MV-ASSESSMENT 2.0 (K103782) | Tomtec Imaging Systems GmbH | 2011-01-27 |
| TRIPLEPLAY-VT VASCULAR THERAPY SYSTEM (K103187) | Wildcat Medical, Inc. | 2011-01-26 |
| DISPOSABLE BLOOD PRESSURE CUF (K102792) | Caremate Medical Device Co., Ltd. | 2011-01-26 |
| MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO (K103780) | Micrus Endovascular Corporation | 2011-01-26 |
| VANTAGE VIEW SYSTEM (K110085) | St Jude Medical | 2011-01-26 |
| STAYHEALTHY BODY COMPOSITION MONITOR-BCM (K101807) | Stayhealthy, Inc. | 2011-01-26 |
| CEROX, MODEL 321OF (K100875) | Or-Nim Medical , Ltd. | 2011-01-25 |
| CHEETAH RELIANT (K103166) | Cheetah Medical, Inc. | 2011-01-25 |
| VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V (K101604) | Vascular Solutions, Inc. | 2011-01-24 |
| FETCH 2 ASPIRATION CATHETER MODEL 109400-001 (K101354) | Medrad Interventional/Possis | 2011-01-21 |
| CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD) (K103746) | Biosense Webster, Inc. | 2011-01-21 |
| PCP/PC STETHOSCOPE (K102893) | Rnk Products, Inc. | 2011-01-20 |
| SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE (K103762) | Sorin Group Deutschland GmbH | 2011-01-20 |
| STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS) (K103468) | Sorin Group Deutschland GmbH | 2011-01-20 |
| COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE (K103715) | Mirador Biomedical, Inc. | 2011-01-20 |
| MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 (K100585) | Gaymar Industries, Inc. | 2011-01-20 |
| VASCOPRESS SEQUENTIAL DVT PUMP (K102940) | Compression Therapy Concepts | 2011-01-20 |
| ALBOGRAFT VASCULAR PROSTHESIS (K103080) | LeMaitre Vascular, Inc. | 2011-01-19 |
| CPS DIRECT SL II SLITTABLE OUTER CATHETER (K103250) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2011-01-19 |
| NEXGEN PERIPHERAL GUIDE CATHETER (K102979) | Nexgen Medical Systems, Inc. | 2011-01-18 |
| CARDIO MED (K103334) | Cardio Medical Products, Inc. | 2011-01-18 |
| RVT CTO DEVICE (K101599) | Revascular Therapeutics, Inc. | 2011-01-18 |
| STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 (K103469) | Sorin Group Deutschland GmbH | 2011-01-18 |
| SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8 (K103652) | Philips Medical Systesms | 2011-01-13 |
| CARDIO MED MODEL A102, H104, O101, P103, AND Z100 (K103159) | Cardio Medical Products, Inc. | 2011-01-11 |
| CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD (K101995) | Oridion Capnography, Inc. | 2011-01-11 |
| HOSMAN USB BLOOD PRESSURE MONITOR; WRIST TYPE AND UPPER ARM TYPE (K103046) | Hosman International Co., Ltd. | 2011-01-10 |
| MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER (K103110) | Abbott Vascular-Cardiac Therapies | 2011-01-10 |
| INTELLIVUE MX40 PATIENT MONITOR (K103646) | Phillips Medical Systems | 2011-01-07 |
| DISPOSABLE BLOOD PRESSURE CUFF (K102823) | Wuxi Medical Instrument Factory | 2011-01-07 |
| KENZ CARDY302 MAX (K101024) | Suzuken Co., Ltd. | 2011-01-06 |
| B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) (K103168) | Sorin Group Deutschland GmbH | 2011-01-06 |
| GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE (K103534) | Trireme Medical, Inc. | 2011-01-05 |
| TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM (K103618) | Ev3, Inc. | 2011-01-05 |
| INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00 (K102974) | Philips Medical Systems | 2011-01-04 |
| CANTATA MICROCATHETER (K101450) | Cook, Inc. | 2010-12-30 |
| VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER (K103153) | Abbott Vascular-Cardiac Therapies | 2010-12-30 |
| VITAL SIGNS MONITOR (K102835) | Edan Instruments, Inc. | 2010-12-27 |
| MEDISTIM VERIQC SYSTEM (K102595) | Medi-Stim Asa | 2010-12-27 |
| LIFEBRIDGE (K103357) | Lifebridge Medizintechnik AG | 2010-12-27 |
| FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030 (K094030) | Cas Medical Systems, Inc. | 2010-12-23 |
| REAVILLMED PRESSURE MONITORING SYSTEM AND PICC (K101189) | Reavillmed | 2010-12-22 |
| PACIFIC XTREME PTCA BALLOON DILATATION CATHETER (K103464) | Medtronic, Inc. | 2010-12-22 |
| LIFEPAK 12 (K102972) | Physio-Control, Inc. | 2010-12-22 |
| PULSE OXIMETER (K102350) | Nonin Medical, Inc. | 2010-12-22 |
| PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F; PRONTO V4 EXTRACTION CATH (K103405) | Vascular Solutions, Inc. | 2010-12-22 |
| MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 (K101982) | St Jude Medical, Crmd | 2010-12-21 |
| UNITY NETWORK ID (K103432) | Ge Medical Systems Information Technologies, Inc. | 2010-12-17 |
| NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION (K102106) | Nihon Kohden Corp. | 2010-12-17 |
| REGIONAL OXIMETER (K102715) | Nonin Medical, Inc. | 2010-12-17 |
| SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301 (K101659) | Vascular Solutions, Inc. | 2010-12-16 |
| AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE (K100646) | Medtronic, Inc. | 2010-12-16 |
| AVITA WRIST TYPE BLOOD PRESSURE MONITOR (K102624) | Avita Corporation | 2010-12-16 |
| V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201 (K101012) | Taidoc Technology Corporation | 2010-12-15 |
| VASCUTRAK PTA DILATATION CATHETER (K103459) | C.R. Bard, Inc. | 2010-12-13 |
| WILLOW/ELM PTA BALLOON DILATATION CATHETER (K102645) | Creagh Medical, Ltd. | 2010-12-10 |
| VASCUCOMP (K103247) | Thermotek, Inc. | 2010-12-10 |
| STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM (K101046) | Sorin Group Deutschland GmbH | 2010-12-09 |
| MULLINS-X PTV CATHETER (K102473) | NuMED, Inc. | 2010-12-09 |
| KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K102609) | Andon Medical Co., Ltd. | 2010-12-09 |
| MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS (K102723) | Memtec Corp. | 2010-12-09 |
| SEEKER CROSSING SUPPORT CATHETER (K103367) | Bard Peripheral Vascular, Inc. | 2010-12-08 |
| PRUITT CAROTID KIT (K103356) | LeMaitre Vascular, Inc. | 2010-12-08 |
| QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD (K101153) | Maquet Cardiopulmonary, AG | 2010-12-08 |
| ARMADA 14 PTA CATHETER (K102705) | Abbott Vascular, Inc. | 2010-12-07 |
| SPACELABS MEDICAL PATIENT MONITORS (K102422) | Spacelabs Medical, Inc. | 2010-12-07 |
| VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 (K100739) | Edwards Lifesciences, LLC | 2010-12-07 |
| NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201 (K102376) | Nihon Kohden Corp. | 2010-12-07 |
| EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M (K100709) | Edwards Lifesciences, LLC | 2010-12-07 |
| MEDICAL MAGNETIC TAPE RECORDER (K102111) | Wpr Medical AS | 2010-12-07 |
| EVERCROSS 0.035 OTW PTA DILATION CATHETER (K103322) | Ev3, Inc. | 2010-12-06 |
| BIOHARNESS (K100040) | Zephyr Technology Corporation | 2010-12-03 |
| PHYSIOFLOW ENDURO (K103283) | Vasocom, Inc. | 2010-12-03 |
| MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIRE (K102818) | Micrus Endovascular Corporation | 2010-12-03 |
| PC ECG (K102854) | Edan Instruments, Inc. | 2010-12-03 |
| ELECTROCARDIOGRAPH (K102830) | Edan Instruments, Inc. | 2010-12-02 |
| MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES (K101577) | Beijing Choice Electronic Technololgy Co., Ltd. | 2010-12-02 |
| HYPERQ AD-100 SYSTEM (K102579) | Biological Signal Processing, Ltd. | 2010-12-02 |
| M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130 (K103214) | Lifeline Systems, Inc. | 2010-12-01 |
| SLEEK OTW PTA CATHETERS (K102035) | ClearStream Technologies , Ltd. | 2010-12-01 |
| MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX (K101784) | Great Batch Medical | 2010-11-26 |
| VITAL SIGNS MONITOR MODEL M3B (K101539) | Edan Instruments, Inc. | 2010-11-24 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K102690) | Andon Health Co, Ltd. | 2010-11-24 |
| OMNI EXPRESS (K103268) | Infinium Medical | 2010-11-23 |
| CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 (K102147) | Cardioquip Llp | 2010-11-19 |