| SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS (K092396) | Spectranetics Corp. | 2009-09-04 |
| GEM HEART ONE/ONE+ (K092576) | Gem-Med S.L. | 2009-09-04 |
| CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER (K090898) | Biosense Webster, Inc. | 2009-09-04 |
| JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE) (K092332) | Pathway Medical Technologies, Inc. | 2009-09-03 |
| SPIROPRO (K092324) | Viasys Healthcare GmbH | 2009-09-03 |
| BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000 (K091841) | Bridgepoint Medical | 2009-09-02 |
| VALVED TEARWAY INTRODUCER (K090394) | Medcomp | 2009-09-01 |
| QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH (K090496) | Cardiac Lead Technologies, Inc. | 2009-09-01 |
| VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS (K091778) | Vascutek, Ltd. | 2009-08-31 |
| VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT (K092486) | Vortex Medical, Inc. | 2009-08-28 |
| CARESCAPE MONITOR B850 (K092027) | Ge Medical Systems Information Technologies | 2009-08-28 |
| MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD (K090869) | Medtronic Perfusion Systems | 2009-08-27 |
| AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM (K091971) | Corventis, Inc. | 2009-08-27 |
| SEGUIN ANNULOPLASTY RING (K092310) | St Jude Medical | 2009-08-27 |
| FOX SV PTA CATHETER (K092286) | Abbott Vascular | 2009-08-27 |
| COMMANDER 111, MODEL CD300-CD399 (K091821) | Cardiocom, LLC | 2009-08-25 |
| BLOOD PRESSURE MONITOR, MODEL FORA P11/TD-3019 (K091897) | Taidoc Technology Corporation | 2009-08-25 |
| SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A (K090936) | Contec Medical System Co., Ltd. | 2009-08-25 |
| CARE PAL, MODEL CPW-10X (K091430) | Digio2 International Co., Ltd. | 2009-08-21 |
| SKINTACT AND VARIOUS OTHER TRADENAMES (K092291) | Leonhard Lang GmbH | 2009-08-21 |
| FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030) (K091452) | Cas Medical Systems, Inc. | 2009-08-21 |
| CABLE, TRANSDUCER, MODEL 2400GN (K083448) | Conmed Corporation | 2009-08-20 |
| TERUMO PALL AL3X ARTERIAL FILTER (K083747) | Terumo Cardiovascular Systems Corp. | 2009-08-20 |
| DISPOSABLE PRESSURE TRANSDUCER (K091408) | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2009-08-18 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915, KD-5031 (K091737) | Andon Health Co, Ltd. | 2009-08-18 |
| SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-388BD (K091738) | Andon Health Co, Ltd. | 2009-08-18 |
| SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-3917, KD 3909 (K091739) | Andon Health Co, Ltd. | 2009-08-18 |
| CHROMA, MODEL: RZ153C (K083382) | Scottcare Corporation | 2009-08-13 |
| SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR (K092315) | Sorin Group Italia S.R.L. | 2009-08-12 |
| MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP (K090662) | Masimo Corporation | 2009-08-10 |
| HORIZON XVU (K091165) | Mennen Medical , Ltd. | 2009-08-07 |
| TRAILBLAZER SUPPORT CATHETER (K092299) | Ev3, Inc. | 2009-08-07 |
| CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH (K091626) | Cryolife, Inc. | 2009-08-07 |
| EN SNARE ENDOVASCULAR SNARE SYSTEM (K092343) | Merit Medical Systems, Inc. | 2009-08-07 |
| AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A (K091548) | Amco International Manufacturing & Design, Inc. | 2009-08-07 |
| CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005 (K092075) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2009-08-07 |
| SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12 (K092064) | Biosense Webster, Inc. | 2009-08-07 |
| APPROACH HYDRO ST WIRE GUIDE, MODEL HMW (K091385) | Cook, Inc. | 2009-08-07 |
| SIGNAL (K090493) | Zargis Medical Corp. | 2009-08-07 |
| CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES (K091856) | Conmed Corporation | 2009-08-07 |
| MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730 (K091062) | Gish Biomedical, Inc. | 2009-08-04 |
| HERO VASCULAR ACCESS DEVICE (K091491) | Hemosphere, Inc. | 2009-07-31 |
| MODIFICATION TO:FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556 (K091500) | Andon Health Co, Ltd. | 2009-07-31 |
| AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002 (K090867) | Ep Dynamics, Inc. | 2009-07-30 |
| LNCS OXIMETRY SENSORS (K083719) | Masimo Corporation | 2009-07-30 |
| MEDOS HILITE RESERVOIR, MODEL: 4030 (K083131) | Gish Biomedical, Inc. | 2009-07-30 |
| NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER (K090918) | Nfocus Neuromedical, Inc. | 2009-07-30 |
| RECRUIT MICROCATHETER (K091563) | Reverse Medical Corporation | 2009-07-30 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7962 (K091997) | Andon Health Co, Ltd. | 2009-07-30 |
| ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040 (K091966) | Angioscore, Inc. | 2009-07-30 |
| MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047 (K091961) | Concentric Medical, Inc. | 2009-07-30 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-738 AND KD-739 (K092045) | Andon Health Co, Ltd. | 2009-07-30 |
| HEART-EXERCISE (K091594) | Ge Medical Systems Information Technologies GmbH | 2009-07-29 |
| WALK400H (K091054) | Et Medical Devices Spa | 2009-07-27 |
| REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR (K090438) | Envitec-Wismar GmbH | 2009-07-24 |
| SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200 (K091513) | Edan Instruments, Inc. | 2009-07-24 |
| DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 (K081603) | Heartforce Medical, Inc. | 2009-07-24 |
| UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE (K091985) | Ivy Biomedical Systems, Inc. | 2009-07-24 |
| ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM (K091075) | iRhythm Technologies, Inc. | 2009-07-21 |
| MD300K1 PULSE OXIMETER (K090599) | Beijing Choice Electronic Technololgy Co., Ltd. | 2009-07-20 |
| 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200 (K083903) | 3M Company | 2009-07-15 |
| PASSPORT V MONITOR, MODEL 0998-00-6100 (K091834) | Datascope Corp., Patient Monitoring Division | 2009-07-15 |
| STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55 (K091008) | Sorin Group Deutschland GmbH | 2009-07-15 |
| MODIFICATION TO MEDICOMPASS CONNECT (K091021) | Imetrikus, Inc. | 2009-07-15 |
| M3 MONITOR (K091908) | Spectrum Medical , Ltd. | 2009-07-10 |
| MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES (K091057) | Masimo Corporation | 2009-07-09 |
| AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-TV3-08F54 (K091793) | Aga Medical Corp. | 2009-07-09 |
| RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20 (K090165) | Masimo Corporation | 2009-07-09 |
| AIRCAST VENAFLOW ELITE SYSTEM (K091700) | Djo, LLC | 2009-07-09 |
| OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S (K091224) | Somanetics Corp. | 2009-07-09 |
| ECSCOPE 200 (K091397) | Dyansys, Inc. | 2009-07-08 |
| AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM (K091882) | MicroVention, Inc. | 2009-07-08 |
| TANITA BODY COMPOSITION ANALYZER, MODEL SC-331 (K090479) | Tanita Corporation of America | 2009-07-07 |
| STREAMER POLYMER GUIDEWIRE (K083094) | Brivant, Ltd. | 2009-07-07 |
| EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST (K091596) | Evalve, Inc. | 2009-07-02 |
| AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05 (K091007) | Sorin Group Deutschland GmbH | 2009-07-02 |
| VORTEX CANNULA (K091304) | Vortex Medical, Inc. | 2009-07-02 |
| ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE (K090554) | Boston Scientific Corp | 2009-07-02 |
| SPECTRANETICS TURBO-TANDEM SYSTEM (K091299) | Spectranetics Corp. | 2009-07-01 |
| CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2 (K090613) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2009-07-01 |
| REGIONAL OXIMETER SYSTEM, MODEL 7600 (K090807) | Nonin Medical, Inc. | 2009-06-30 |
| ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS (K091593) | Possis Medical, Inc. | 2009-06-22 |
| SMART-LOGIC AUTO DIGITAL UPPERARM BLOOD PRESSURE MONITOR, MODEL KP-7500, FULLY FUZZY AUTO DIGITAL UPPER ARM BLOOD PRESSU (K083753) | K-Jump Health Co., Ltd. | 2009-06-19 |
| JETSTREAM G2 NXT SYSTEM, MODEL PV20300 (K091509) | Pathway Medical Technologies, Inc. | 2009-06-19 |
| VASCUTEK BRANCHED GELWEAVE (K090987) | Vascutek, Ltd. | 2009-06-19 |
| MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00 (K091504) | Micrus Endovascular Corporation | 2009-06-19 |
| NUVANT CARDIAC EVENT MONITORING SYSTEM; NUVANT MOBILE CARDIAC TELEMETRY SYSTEM (K090696) | Corventis, Inc. | 2009-06-19 |
| FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100 (K090621) | Flowcardia, Inc. | 2009-06-19 |
| PIGGYBACK WIRE CONVERTER (K090977) | Vascular Solutions, Inc. | 2009-06-18 |
| BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM (K080941) | N.I. Medical, Ltd. | 2009-06-18 |
| DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02 (K091449) | Datascope Corp., Cardiac Assist Division | 2009-06-18 |
| LUCAS 2 (K090422) | Jolife AB | 2009-06-17 |
| TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE (K090180) | Vermed, Inc. | 2009-06-17 |
| DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES (K081259) | Defibtech, LLC | 2009-06-15 |
| ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER (K091527) | Cook, Inc. | 2009-06-12 |
| FLOCONTROL , MODEL 1028 (K090970) | Coaxia, Inc. | 2009-06-12 |
| GOPHER GOLD CATHETER, MODEL 5620 (K091345) | Vascular Solutions, Inc. | 2009-06-12 |
| QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000 (K090511) | Maquet Cardiopulmonary, AG | 2009-06-12 |
| PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D (K090671) | Contec Medical System Co., Ltd. | 2009-06-11 |
| SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT SILICONE SOFT TIP SPO2 SENSOR (K083010) | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2009-06-10 |