| JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100 (K101221) | Pathway Medical Technologies, Inc. | 2010-06-02 |
| VIEWFLEX PLUS ICE CATHETER (K101239) | St Jude Medical | 2010-06-02 |
| MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20D (K100617) | Masimo Corporation | 2010-05-28 |
| REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER (K100254) | Ascent Healthcare Solutions | 2010-05-28 |
| FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY (K100427) | Taidoc Technology Corporation | 2010-05-28 |
| MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCH BP OFFICE AFIB (TWIN200 AFS). (K101275) | Microlife Intellectual Property GmbH | 2010-05-28 |
| IQVITALS AND IQVITALS SYSTEM (K100913) | Brentwood Medical Technology Corp. | 2010-05-26 |
| BLOOD PRESSURE METER MODEL CH-101 (K100553) | Citizen Systems Japan Co., Ltd. | 2010-05-25 |
| HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL (K101011) | Abbott Vascular, Inc. | 2010-05-24 |
| POLYTEL(R) APT MODEL: PWA-08-01 (K100524) | Polymap Wireless, LLC | 2010-05-24 |
| PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054 (K100769) | Penumbra, Inc. | 2010-05-21 |
| GUARDIAN II NC HEMOSTASIS VALVE (K101113) | Zerusa Limited | 2010-05-21 |
| SONIC SHOT GX (K091734) | Nemoto Kyorindo Co., Ltd. | 2010-05-21 |
| LYMPHA PRESS 201MAX, MODEL 201MAX (K100677) | Mego Afek AC , Ltd. | 2010-05-20 |
| ALLY PLATFORM SYSTEM (K093895) | Continuity Health Solutions | 2010-05-20 |
| JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100 (K100462) | Pathway Medical Technologies, Inc. | 2010-05-19 |
| TERUMO LAUER LOCK ADAPTER (K093992) | Terumo Cardiovascular Systems Corporation | 2010-05-19 |
| HANDHELD PULSE OXIMETER MODEL MD300A/ MD300K2/ MD300M (K100203) | Beijing Choice Electronic Technololgy Co., Ltd. | 2010-05-17 |
| LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS (K094046) | Masimo Corporation | 2010-05-14 |
| COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS (K100521) | Mego Afek AC , Ltd. | 2010-05-14 |
| GLIDER PTA BALLOON CATHETER (K101062) | Trireme Medical, Inc. | 2010-05-12 |
| NAVIGATOR CLINICAL GUIDENCE SYSTEM (K092219) | Applied Physiology Pty , Ltd. | 2010-05-12 |
| INTELLIVUE PATIENT MONITOR (K093268) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010-05-11 |
| TEMPUS IC PROFESSIONAL PATIENT MONITOR (K101264) | Remote Diagnostic Technologies , Ltd. | 2010-05-11 |
| BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (K101078) | Bl Healthcare, Inc. | 2010-05-10 |
| MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L (K100274) | Medtronic, Inc. | 2010-05-10 |
| OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE (K093813) | Imbiotechnologies | 2010-05-10 |
| INTCO TAB ELECTRODE (K093327) | Shanghai Intco Electrode Manufacturing Co., Ltd. | 2010-05-10 |
| SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 MODEL: 863063, 863064, 863065, 863066, 863068 (K101067) | Philips Medical Systems | 2010-05-07 |
| VITALOGIK 6000/6500 (K093766) | Mennen Medical , Ltd. | 2010-05-07 |
| BLOOD PRESSURE MONITOR/ MODELS (K093739) | Ningbo Diaier Electronic Co., Ltd. | 2010-05-07 |
| A.B. KORKOR MEDICAL SKINNYSAFE INTRODUCER SHEATH (K092097) | A.B. Korkor Medical, Inc. | 2010-05-06 |
| CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B (K100508) | Carematix, Inc. | 2010-05-05 |
| KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES (K100306) | Covidien | 2010-05-04 |
| ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA (K100523) | Hygia Health Services, Inc. | 2010-05-04 |
| QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA (K100278) | Maquet Cardiopulmonary, AG | 2010-04-30 |
| ADMIRAL XTREME PTA BALLOON DILATATION CATHETER (K100921) | Invatec S.P.A. | 2010-04-30 |
| INTELLIVUE PATIENT MONITOR MODEL: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 AND MP90 (K100939) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010-04-30 |
| PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J (K100930) | Volcano Corporation | 2010-04-30 |
| INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650 (K100915) | Hutchinson Technology, Inc. | 2010-04-30 |
| VSI TORQUE DEVICE (K100093) | Vascular Solutions, Inc. | 2010-04-30 |
| ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL 08-514, 08-521, 08-536, 08-557, 08-603 (K100266) | Camntech, Ltd. | 2010-04-29 |
| VITAL SYNC MODEL 5000 SERIES (K093422) | Somanetics Corp. | 2010-04-29 |
| STELLAR 300 (K093017) | Larsen & Toubro Limited | 2010-04-29 |
| MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L (K100319) | Merit Medical Systems, Inc. | 2010-04-28 |
| ROLL-X GUIDEWIRE (K100710) | St Jude Medical | 2010-04-28 |
| 12 LEAD GLOVE (K100315) | I Needmd, Inc. | 2010-04-23 |
| ALLIGATOR-HD RETRIEVAL DEVICE (ARD-HD), MODEL FA-88840-XX (K093977) | Chestnut Medical Technologies, Inc. | 2010-04-22 |
| MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST (K100789) | Evalve, Inc. | 2010-04-21 |
| GTX 12 GIDEWIRE (K100470) | Medtronic, Inc. | 2010-04-21 |
| VITAPHONE. MODEL 100 BT (K100383) | Vitasystems GmbH | 2010-04-20 |
| CLEARWAY OTW MODEL 85912 (K093431) | Atrium Medical Corp. | 2010-04-20 |
| TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM (K100155) | Biomedical Systems Corp. | 2010-04-20 |
| GDS-DC12 (K100135) | Guided Delivery Systems | 2010-04-16 |
| ELI 230 ELECTROCARDIOGRAPH (K100127) | Mortara Instrument, Inc. | 2010-04-16 |
| CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 (K100663) | Boston Scientific Corporation | 2010-04-16 |
| LIFEBED NETWORK PATIENT VIGILANCE SYSTEM (K100745) | Hoana Medical, Inc. | 2010-04-15 |
| MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A (K100394) | Shanghai 3f Electronics Co, Ltd. | 2010-04-15 |
| INTELLIVUE CLINICAL INFORMATION PORTFOLIO (K100272) | Philips Medical Systems | 2010-04-14 |
| WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE (K093907) | Welch Allyn, Inc. | 2010-04-14 |
| CAMBRIDGE HEART OEM (K100362) | Cambridge Heart, Inc. | 2010-04-14 |
| RETROFLEX DILATOR KIT (K093554) | Edwards Lifesciences, LLC | 2010-04-13 |
| RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX (K100892) | Boston Scientific Corp | 2010-04-12 |
| ULTRAVIEW DM3 MONITOR (K093802) | Zoe Medical, Inc. | 2010-04-09 |
| CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION (K093288) | Cardionet, Inc. | 2010-04-08 |
| M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000 (K100046) | Guangdong Biolight Meditech Co., Ltd. | 2010-04-08 |
| PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A (K093858) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2010-04-02 |
| COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 2301 (K092785) | Vasomedical, Inc. | 2010-04-02 |
| PADCHECK (K093205) | Padtest, LLC | 2010-04-01 |
| SE-601 SERIES ELECTROCARDIOGRAPH (K093869) | Edan Instruments, Inc. | 2010-04-01 |
| MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED (K092391) | Concord Medical Products | 2010-04-01 |
| HANDHELD ECG MONITOR, MODEL MD100 (K093872) | Beijing Choice Electronic Technololgy Co., Ltd. | 2010-03-31 |
| ARSTASIS ACCESS SYSTEM (K100615) | Arstasis, Inc. | 2010-03-30 |
| VITAL SIGNS MONITOR (K093016) | Shenzhen Creative Industry Co., Ltd. | 2010-03-30 |
| TORQMAX SHEATH GRIP ACCESSORY (K093257) | Spectranetics Corp. | 2010-03-26 |
| FORECARE ADVANCED SPORT WRIST BLOOD PRESSURE MONITOR, MODEL FP-0217 (K092061) | Genexel Medical Instrument, Inc. | 2010-03-26 |
| RAISIN PERSONAL MONITOR (K093976) | Proteus Biomedical, Inc. | 2010-03-25 |
| FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT (K093831) | Health & Life Co., Ltd. | 2010-03-25 |
| XRES BLOOD COLLECTION RESERVOIR (K100507) | Sorin Group Italia S.R.L. | 2010-03-24 |
| EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION FEATURE (K090364) | Angioslide, Ltd. | 2010-03-23 |
| SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT (K094044) | Tayside Flow Technologies Limited | 2010-03-23 |
| GORE DRYSEAL SHEATH (K093791) | W. L. Gore & Associates, Inc. | 2010-03-22 |
| ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY (K100303) | Angioscore, Inc. | 2010-03-22 |
| NBM-200MP PULSE OXIMETRY DEVICE (K091564) | Orsense, Ltd. | 2010-03-19 |
| WRIST TYPE BLOOD PRESSURE MONITOR, HMBPM-005/KINETIK BRANDED BPM2 SERIES (K092558) | Harvard Medical Devices , Ltd. | 2010-03-17 |
| ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS (K093965) | C.R. Bard, Inc. | 2010-03-17 |
| GORE HYBRID VASCULAR GRAFT (K093934) | W.L. Gore & Associates | 2010-03-17 |
| LITEPAC, MODEL 682 (K100490) | ClearStream Technologies , Ltd. | 2010-03-16 |
| NEUROSCOUT STEERABLE GUIDEWIRE (K100351) | Codman & Shurtleff, Inc. | 2010-03-16 |
| OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER (K093232) | Great Batch Medical | 2010-03-15 |
| TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR (K093881) | GE Healthcare Finland Oy | 2010-03-12 |
| SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES (K092950) | Solaris Medical Technology, Inc. | 2010-03-12 |
| INBODY, MODELS: 270, R20, R20B (K092786) | Biospace Corporation Limited | 2010-03-10 |
| DX SERIES FINGER SENSOR (K100020) | Dixtal Medical, Inc. | 2010-03-08 |
| INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION (K093788) | Draeger Medical Systems, Inc. | 2010-03-08 |
| ACUITY BREAK-AWAY GUIDE CATHETER (K093969) | Cardiac Pacemakers, Inc. | 2010-03-05 |
| CIRCUFLOW 5100 SEQUENTIAL COMPRESSION DEVICE (K100446) | Devon Medical, Inc. | 2010-03-05 |
| SINGLE-PATIENT USE DISPOSABLE SENSOR (K093306) | Nonin Medical, Inc. | 2010-03-04 |
| VRLXP, MODEL XP (K091732) | Deep Breeze , Ltd. | 2010-03-04 |
| MD300C1 FINGERTIP PULSE OXIMETER (K093757) | Beijing Choice Electronic Technololgy Co., Ltd. | 2010-03-03 |