| ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE (K103057) | Asahi Intecc Co., Ltd. | 2010-11-19 |
| MOORVMS-PRES PRESSURE CUFF CONTROLLER (K102433) | Moor Instruments, Ltd. | 2010-11-18 |
| CRITICOOL PRO (K102112) | Mtre Advanced Technology , Ltd. | 2010-11-18 |
| MICROPLEX COIL SYSTEM- COSMOS (K102365) | MicroVention, Inc. | 2010-11-18 |
| MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1 (K101031) | Masimo Corporation | 2010-11-18 |
| CONCENTRIC BALLOON GUIDE CATHETER (K102657) | Concentric Medical, Inc. | 2010-11-17 |
| PTFE PORTABLE INTRODUCER (K102540) | Great Batch Medical | 2010-11-16 |
| MINIATURIZE CHEST COMPRESSOR (MCC) (K102068) | Resuscitation International | 2010-11-16 |
| DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325 (K100565) | Bio-Detek, Inc. | 2010-11-16 |
| WELCH ALLYN 1500 PATIENT MONITOR (K101619) | Schiller AG | 2010-11-12 |
| ELECTRONIC BLOOD PRESURE MONITOR (K102988) | Shenzhen Pango Electronic Co., Ltd. | 2010-11-09 |
| ATRAUMATIC VASCULAR CLAMPS (K102048) | Geomed Medizin-Technik GmbH & Co. KG | 2010-11-09 |
| SEQURE SNARE SYSTEM (K102484) | Lifetech Scientific (Shenzhen) Co., Ltd. | 2010-11-09 |
| LIFENET SYSTEM (K102757) | Physio-Control, Inc. | 2010-11-05 |
| KD-931D FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K102631) | Andon Health Co, Ltd. | 2010-11-04 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K102930) | Andon Health Co, Ltd. | 2010-11-03 |
| WMI REPROCESSED DVT WRAP, WMI REPROCESSED THERMAL WRAP MODEL: RD-1000F, RD-1000C, RT 2000A, RT 2000B, RT 2000KF, RT 2000 (K101035) | Wmi Enterprises, LLC | 2010-10-29 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K102906) | Andon Health Co, Ltd. | 2010-10-29 |
| REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS (K092896) | Nemoto Kyorindo Co., Ltd. | 2010-10-29 |
| GUIDED MEDICAL POSITIONING SYSTEM II (GMPS II) (K102905) | Mediguide, Ltd. | 2010-10-29 |
| NEXFIN MODEL 2 (K101123) | Bmeye B.V. | 2010-10-28 |
| XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS (K101571) | Witt Biomedical Corp | 2010-10-26 |
| EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA (K102420) | Edwards Lifesciences, LLC | 2010-10-26 |
| AUGEASE VASCULAR AUGMENTATION DEVICE (K101355) | Augdvt, LLC | 2010-10-26 |
| VECTOR EVENT GRID ARCHITECTURE (VEGA) SYSTEM (K102135) | Nuvon, Inc. | 2010-10-22 |
| SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON (K103095) | Medtronic, Ireland | 2010-10-22 |
| SENSEI X ROBOTIC CATHETER SYSTEM (K102168) | Hansen Medical, Inc. | 2010-10-22 |
| KANEKA PHARMA AMERICA XPRESS-WAY RX (K101839) | Kaneka Pharma America, LLC | 2010-10-22 |
| INTELLIVUE PATIENT MONITOR, MODELS MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800 (K102562) | Philips Medizin Systeme Boblingen GmbH | 2010-10-21 |
| CHARMCARE TABLETOP PULSE OXIMETER (K092641) | Charmcare Co., Ltd. | 2010-10-21 |
| MASIMO LNCS/M-LNCS OXIMETRY SENSORS (K101896) | Masimo Corporation | 2010-10-21 |
| CARESCAPE MODEL V100 VITAL SIGNS MONITOR (K102426) | Ge Medical Systems Information Technologies | 2010-10-20 |
| DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY (K101497) | Oscor, Inc. | 2010-10-20 |
| UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX (K093244) | Geratherm Medical AG | 2010-10-19 |
| VASOGRAD DVT COMPRESSION GARMENT (K102732) | Compression Therapy Concepts | 2010-10-19 |
| KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER (K102737) | Covidien, LLC | 2010-10-19 |
| HRV ACQUIRE (K092809) | Wr Medical Electronics Co. | 2010-10-19 |
| LIVEWIRE ELECTOPHYSIOLOGY CATHETER (K102721) | St Jude Medical | 2010-10-18 |
| CARESCAPE MONITOR B650 (K102239) | GE Healthcare Finland Oy | 2010-10-18 |
| ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058 (K101955) | St Jude Medical | 2010-10-15 |
| ELECTRONIC BLOOD PRESSURE MONITOR (K102920) | Shenzhen Pango Electronic Co., Ltd. | 2010-10-15 |
| BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS (K100310) | BTL Industries, Inc. | 2010-10-13 |
| COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE (K101518) | Mirador Biomedical, Inc. | 2010-10-13 |
| COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593 (K101987) | Zoll Circulation | 2010-10-12 |
| EMCOOLSPAD (K100071) | Emcools Emergency Medical Cooling Systems AG | 2010-10-12 |
| LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE (K101331) | C.R. Bard Inc., Bard Electrophysiology Division | 2010-10-08 |
| MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE (K101280) | Midwest Reprocessing Center, LLC | 2010-10-07 |
| NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL T100A-090103 (K100077) | Solaris Medical Technology, Inc. | 2010-10-07 |
| ARTERIOFLOW MODEL 7500 SEQUENTIAL COMPRESSION DEVICE (K102582) | Devon Medical, Inc. | 2010-10-07 |
| ARSTASIS ACCESS SYSTEM (K102728) | Arstasis, Inc. | 2010-10-07 |
| ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT (K102596) | Atrium Medical Corp. | 2010-10-05 |
| TRUSIGNAL SPO2 FINGERTIP SENSOR (K101871) | GE Healthcare Finland Oy | 2010-10-04 |
| WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS (K101148) | Cincinnati Sub-Zero Products, Inc. | 2010-10-01 |
| M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0 (K102495) | Philips Medical Systems | 2010-09-30 |
| ZOLL PROPAQ MD (K102468) | Zoll Medical Corporation, World Wide Headquarters | 2010-09-30 |
| PERCU-PRO GUIDEWIRE (K094062) | Cardiosolutions, Inc. | 2010-09-27 |
| PATIENT MONITOR (K102040) | Guangdong Biolight Meditech Co., Ltd. | 2010-09-24 |
| ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE (K091561) | ZOLL Medical Corporation | 2010-09-23 |
| GUIDE CATHETERS AND ACCESSORIES (K101015) | Thomas Medical Products, Inc. | 2010-09-23 |
| NEOWIRE PTA/PTCA GUIDEWIRE (K101729) | Neometrics, Inc. | 2010-09-23 |
| ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S (K100578) | Asahi Intecc Co., Ltd. | 2010-09-22 |
| CRITICAL CARE ASSESSMENT (K101983) | Critical Patient Care, Inc. | 2010-09-21 |
| GERATHERM UNIQUERESC (K093694) | Geratherm Medical AG | 2010-09-20 |
| WMI DVT WRAP, WMI THERMAL WRAP MODEL: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF, T-2000S, T-2000N (K100969) | Wmi Enterprises, LLC | 2010-09-20 |
| ALBOSURE POLYESTER VASCULAR PATCH (K101740) | LeMaitre Vascular, Inc. | 2010-09-20 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534 (K102356) | Andon Health Co, Ltd. | 2010-09-20 |
| BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS (K101589) | Cincinnati Sub-Zero Products, Inc. | 2010-09-20 |
| MODEL SB100II FINGER PULSE OXIMETER (K101568) | Atlantean | 2010-09-20 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-513 (K102353) | Andon Health Co, Ltd. | 2010-09-17 |
| SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A (K101968) | St Jude Medical | 2010-09-15 |
| ZOLL PROPAQ M (K102174) | Zoll Medical Corporation, World Wide Headquarters | 2010-09-15 |
| BLOOD PRESSURE METER, MODEL CH-658 (K102303) | Citizen Systems Japan Co., Ltd. | 2010-09-10 |
| E.S.O. (ELECTRO SENSOR OXI) (K102442) | Ld Technology, LLC | 2010-09-10 |
| TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET (K102430) | Tyco Electronics Corporation | 2010-09-10 |
| ENDEAVOUR MONITORING SYSTEM (K102004) | Mindray DS USA, Inc. | 2010-09-10 |
| ACTA VESSEL OCCLUSION SYSTEM (VOS) (K091952) | Nfocus Neuromedical, Inc. | 2010-09-10 |
| MEDTRONIC C315 DELIVERY CATHETER (K101885) | Medtronic, Inc. | 2010-09-09 |
| HANDHELD PULSE OXIMETER MODEL M800 (K101694) | Guangdong Biolight Meditech Co., Ltd. | 2010-09-08 |
| 6F ENGAGE/ENGAGE TR INTRODUCER (K101883) | St Jude Medical | 2010-09-07 |
| AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG (K101186) | Medtronic Perfusion Systems | 2010-09-03 |
| 3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM (K101834) | 3M Company | 2010-09-03 |
| CRUISER 18 GUIDEWIRE (K102211) | Brivant, Ltd. | 2010-09-03 |
| VITAL SIGNS MONITOR (K101602) | Criticare Systems, Inc. | 2010-09-01 |
| FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10 (K102176) | Medtronic Cryocath, LP | 2010-09-01 |
| INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 (K100518) | Instrumed International, Inc. | 2010-08-31 |
| ARCHER SUPER STIFF GUIDEWIRES (K101339) | Medtronic, Inc. | 2010-08-31 |
| INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL (K101600) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010-08-31 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-930 (K101950) | Andon Health Co, Ltd. | 2010-08-31 |
| BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5 (K092449) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010-08-30 |
| BLOOD PRESSURE METER, MODEL CH-609 (K100055) | Citizen Systems Japan Co., Ltd. | 2010-08-30 |
| MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS (K101702) | Midwest Reprocessing Center, LLC | 2010-08-27 |
| MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCH BP HOME N BP3MX1-4 (K100763) | Microlife Intellectual Property GmbH | 2010-08-27 |
| HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M- (K101892) | Heine Optotechnik GmbH & Co. KG | 2010-08-27 |
| LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR (K102129) | Levitronix, LLC | 2010-08-27 |
| MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS, MIDWEST REPROCESSING CENTER REPROCESSED ALP SLE (K101330) | Midwest Reprocessing Center, LLC | 2010-08-27 |
| DUFLO CATHETER (HEPARIN COATED) (K093847) | Thermopeutix, Inc. | 2010-08-25 |
| REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS (K101789) | Sterilmed, Inc. | 2010-08-19 |
| PICC WAND PEELABLE SAFETY INTRODUCER (K101150) | Access Scientific, Inc. | 2010-08-13 |
| INQUIRY AFOCUSII DIAGNOSTIC CATHETER (K101623) | St Jude Medical | 2010-08-13 |
| COMBAT READY CLAMP (K102025) | Combat Medical Systems, LLC | 2010-08-11 |