| ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8 (K101660) | Kepler Medtec | 2010-08-11 |
| OMNI III PATIENT MONITOR (K101052) | Infinium Medical | 2010-08-11 |
| WINGMAN EXTENDABLE TIP SUPPORT CATHETER (K101479) | Reflow Medical | 2010-08-11 |
| MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R (K101212) | Medtronic, Inc. | 2010-08-07 |
| EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0 (K100376) | Earlysense, Ltd. | 2010-08-06 |
| HEADWAY 17 ADVANCED MICROCATHETER (K101542) | MicroVention, Inc. | 2010-08-06 |
| STINGRAY ORIENTING BALLOON CATHETER (K101591) | Bridgepoint Medical | 2010-08-06 |
| VASOPRESS SUPREME MINI MODEL VP500DM (K101915) | Compression Therapy Concepts, Inc. | 2010-08-06 |
| WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S (K102022) | Avinger, Inc. | 2010-08-06 |
| WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500 (K101647) | Avinger, Inc. | 2010-08-06 |
| OCCLUSION BALLOON CATHETER MODEL OBC (K101877) | Cook, Inc. | 2010-08-06 |
| CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K (K101198) | Computerized Screening, Inc. | 2010-08-04 |
| REEFLEX PTA CATHETER (K101361) | ClearStream Technologies , Ltd. | 2010-08-04 |
| THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER (K100819) | Onset Medical Corporation | 2010-08-02 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL: KD-5963NU, KD-5008 (K101010) | Andon Health Co, Ltd. | 2010-07-30 |
| ZOLL PROPAQ MD (K100654) | Zoll Medical Corporation, World Wide Headquarters | 2010-07-29 |
| ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O (K101521) | Philips Medical Systems | 2010-07-29 |
| POWERWIRE RADIOFREQUENCY GUIDEWIRE (K101615) | Baylis Medical Co., Inc. | 2010-07-28 |
| HYDROFIX VASO SHIELD, MODEL HVS-001-0610 (K101826) | Mimedx Group, Inc. | 2010-07-28 |
| CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH (K101866) | Cryolife, Inc. | 2010-07-23 |
| QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB (K100813) | Pulse Biomedical, Inc. | 2010-07-23 |
| PIONEER PLUS CATHETER, MODEL PLUS 120 (K101777) | Medtronic Vascular | 2010-07-23 |
| REPROCESSED COMPRESSION SLEEVES (K100909) | Ascent Healthcare Solutions | 2010-07-23 |
| AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1 (K100133) | Airstrip Technologies, LP | 2010-07-23 |
| SCOUTPRO ACS (K101776) | Biotronik, Inc. | 2010-07-23 |
| CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES (K101576) | Team Innovations, Inc. | 2010-07-22 |
| YRNSORTIP OXIMANOMETER (K093981) | Cnoga Medical , Ltd. | 2010-07-22 |
| SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS (K101972) | Solaris Medical Technology, Inc. | 2010-07-22 |
| WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0 (K101674) | Athena Gtx | 2010-07-21 |
| VISCOPE, MODEL 100P,100S (K100531) | Hd Medical Services (India) Pvt.Ltd | 2010-07-21 |
| SCOUTPRO HEMOSTATIC VALVE (K101282) | Biotronik, Inc. | 2010-07-21 |
| GLIDESHEATH (K102008) | Terumo Medical Corp. | 2010-07-21 |
| COHEN CROSSOVER CATHETER (K101625) | Vascular Solutions, Inc. | 2010-07-19 |
| LEV-OR DILATION CATHETER OTW (K101117) | Baylis Medical Co., Inc. | 2010-07-16 |
| REPROCESSED RESTEP COMPRESSION SLEEVES (K101087) | Ascent Heatlhcare Solutions | 2010-07-16 |
| ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000 (K101092) | Medivance, Inc. | 2010-07-16 |
| ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC (K093903) | Genesee Biomedical, Inc. | 2010-07-15 |
| ENSITE VELOCITY SYSTEM (K101328) | St Jude Medical | 2010-07-14 |
| ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY (K101735) | Angioscore, Inc. | 2010-07-14 |
| PENUMBRA CATHERER 025 (K100826) | Penumbra, Inc. | 2010-07-13 |
| HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS (K101570) | Micro Therapeutics Dba Ev3 Neurovascular | 2010-07-13 |
| PTA-DUO PTA BALLOON CATHETER (K101047) | Hotspur Technologies | 2010-07-13 |
| MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084 (K101703) | Card Guard Scientific Survival , Ltd. | 2010-07-13 |
| EMBO PLUS EMBOLECTOMY CATHETER (K100840) | Hotspur Technologies | 2010-07-12 |
| PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM (K100842) | Hotspur Technologies | 2010-07-12 |
| MD2000B VITAL SIGN MONITOR, MODEL MD2000B (K100740) | Beijing Choice Electronic Technololgy Co., Ltd. | 2010-07-09 |
| ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE (K101651) | Cordis Corp. | 2010-07-09 |
| U-RIGHT TD-3127 BLOOD PRESSURE MONITORING SYSTEM (K100658) | Taidoc Technology Corporation | 2010-07-09 |
| PULMOTRACK 5050 WHOLTER, MODEL 5050 (K101022) | Karmelsonix | 2010-07-09 |
| WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES (K101680) | Welch Allyn, Inc. | 2010-07-09 |
| MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER (K100428) | Masimo Corporation | 2010-07-09 |
| 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM (K092853) | Galix Biomedical Instrumentation, Inc. | 2010-07-09 |
| HI-TORQUE WINN GUIDE WIRE FAMILY (K101648) | Abbott Vascular, Inc. | 2010-07-08 |
| IMPELLA CONTROLLER (K093801) | Abiomed, Inc. | 2010-07-08 |
| XYLOS VESSEL GUARD (K100984) | Xylos Corporation | 2010-07-07 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR , MODEL KN-550 (K100620) | Harvard Medical Devices , Ltd. | 2010-07-02 |
| ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT) (K101667) | St Jude Medical | 2010-07-02 |
| MD VISION SYSTEM (K101474) | Perkins Healthcare Technologies | 2010-07-02 |
| CHEETAH NICOM SYSTEM (K101487) | Cheetah Medical, Inc. | 2010-07-02 |
| MISTRAL-AIR WARMING SYSTEM (K101705) | The Surgical Company International B.V. | 2010-07-02 |
| ELI 250 ELECTROCARDIOGRAPH (K101403) | Mortara Instrument, Inc. | 2010-07-02 |
| THERMODILUTION CATHETER (K101669) | Biosensors Intl. Pte. , Ltd. | 2010-07-01 |
| MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCHBP OFFICE TARGET (BP3MD1-4). (K101512) | Microlife Intellectual Property GmbH | 2010-07-01 |
| IP-SET (K101685) | Integral Process Sas | 2010-07-01 |
| RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26 (K093877) | Edwards Lifesciences, LLC | 2010-07-01 |
| LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 (K093993) | Infraredx, Inc. | 2010-06-30 |
| MODIFICATION TO INTEL HEALTH GUIDE PHS6000 (K101178) | Intel Corp. | 2010-06-29 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 (K100940) | Andon Health Co, Ltd. | 2010-06-29 |
| ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS (K101431) | C.R. Bard, Inc. | 2010-06-25 |
| CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR (K101639) | Card Guard Scientific Survival , Ltd. | 2010-06-25 |
| HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH (K101116) | Abbott Vascular-Cardiac Therapies | 2010-06-23 |
| MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7 (K100403) | Masimo Corporation | 2010-06-23 |
| WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04, (K101345) | Biosense Webster, Inc. | 2010-06-22 |
| AFFIITY CP CENTRIFUGAL BLOOD PUMP (K100631) | Medtronic, Inc. | 2010-06-22 |
| SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12 (K101138) | Biosense Webster, Inc. | 2010-06-22 |
| CARTO XP EP NAVIGATION SYSTEM, VERSION 10 (K093566) | Biosense Webster, Inc. | 2010-06-18 |
| LASSO NAV CATHETER (K093376) | Biosense Webster, Inc. | 2010-06-18 |
| INTELLIVUE PATIENT MONITOR (K101449) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010-06-18 |
| PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48) (K091786) | Pulsion Medical Systems AG | 2010-06-18 |
| ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150 (K101115) | Mortara Instrument, Inc. | 2010-06-18 |
| V-TRUST TD-8002 MULTI-PARAMETER SPOT-CHECK MONITOR MODEL TD-8002 (K101259) | Taidoc Technology Corporation | 2010-06-17 |
| CIRCUFLOW 5200 SEQUENTIAL COMPRESSION DEVICE (K101523) | Devon Medical, Inc. | 2010-06-17 |
| COAXIAL INTRODUCER SET (K101399) | Martech Medical Products | 2010-06-17 |
| HASKAL TORQUE DEVICE (K100425) | Elcam Medical Acal | 2010-06-17 |
| ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001 (K101406) | Medrad Interventional/Possis | 2010-06-16 |
| OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316 (K100815) | Oxypulse | 2010-06-16 |
| GENESIS DM MODEL: 6053000A1 (K101242) | Honeywell Hommed, LLC | 2010-06-11 |
| PATIENT MONITOR, MODEL PM50 (K101127) | Contec Medical System Co., Ltd. | 2010-06-11 |
| ENSITE VELOCITY SYSTEM, MODEL EE3000 (K101419) | St Jude Medical | 2010-06-11 |
| AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X (K100129) | Ambu A/S | 2010-06-11 |
| JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON (K101334) | Pathway Medical Technologies, Inc. | 2010-06-11 |
| BLOOD PRESSURE METER, MODEL CH-4532 (K093931) | Citizen Systems Japan Co., Ltd. | 2010-06-10 |
| VITAL SIGNS MONITOR-VSM 6000 SERIES (K101445) | Welch Allyn, Inc. | 2010-06-08 |
| LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30 (K100217) | Mediana Co., Ltd. | 2010-06-08 |
| A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200 (K101002) | Healthstats International Pte. , Ltd. | 2010-06-08 |
| SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES (K093853) | Nonin Medical, Inc. | 2010-06-04 |
| HOTDOG MULTI FUNCTION CONTROLLER (K094056) | Augustine Biomedical & Design, LLC | 2010-06-03 |
| CARECENTER MD (K093211) | Cardiac Science Corporation | 2010-06-03 |
| AMBULATORY BLOOD PRESSURE MONITOR, MODELS FB-270 AND DS-270 (K093102) | Nihon Seimitsu Sokki Co., Ltd. | 2010-06-03 |
| HYDROFIX SURGICAL SHEET (K100905) | Mimedx Group, Inc. | 2010-06-02 |