| TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM (K111723) | Ev3, Inc. | 2011-10-27 |
| VSI GUIDEWIRE (K112631) | Vascular Solutions, Inc. | 2011-10-27 |
| ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID (K112917) | Medtronic, Inc. | 2011-10-27 |
| SPIDERFX EMBOLIC PROTECTION DEVICE (K111010) | Ev3, Inc. | 2011-10-27 |
| ZOLL RESCUENETLINK (K111296) | Zoll Medical Corporation, World Wide Headquarters | 2011-10-27 |
| MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORS (K111621) | Masimo Corporation | 2011-10-26 |
| REVIVE INTERMEDIATE CATHETER (REVIVE IC) (K112828) | Codman & Shurtleff, Inc. | 2011-10-25 |
| PATIENT MONITOR (K112803) | Guangdong Biolight Meditech Co., Ltd. | 2011-10-24 |
| MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT (K112497) | C.R. Bard, Inc. | 2011-10-24 |
| AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR) (K110569) | Inovise Medical, Inc. | 2011-10-24 |
| AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER (K111854) | St. Jude Medical Systems AB | 2011-10-21 |
| REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER (K112292) | Stryker Sustainability Solutions | 2011-10-21 |
| PHYSIOGLOVE ES WITH ECG ANALYSIS (K103791) | Commwell , Ltd. | 2011-10-21 |
| DELTEX MEDICAL CARDIOQ EDM (K111542) | Deltex Medical Limited | 2011-10-20 |
| OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100 FOR WRIST TYPE (K112269) | OSTAR MEDITECH CORP. | 2011-10-20 |
| NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE (K110315) | Nexgen Medical Systems, Inc. | 2011-10-20 |
| V-14 CONTROL WIRE GUIDEWIRE (K112745) | Boston Scientific Corporation | 2011-10-18 |
| ABDOMINAL TOURNIQUET SYSTEM (K112384) | Compression Works, LLC | 2011-10-18 |
| CARDIA-CATH (K112323) | Millar Instruments, Inc. | 2011-10-18 |
| 8FR TURBO - TANDEM SYSTEM (K112032) | Spectranetics Corp. | 2011-10-17 |
| BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG (K112771) | Sorin Group Italia S.R.L. | 2011-10-14 |
| MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE (K112086) | Medrad, Inc. | 2011-10-14 |
| EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER (K112694) | Edwards Lifesciences, LLC | 2011-10-14 |
| MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM (K111200) | GE Healthcare | 2011-10-12 |
| BANTAM CATHETER (280MM BALLOON LENGTHS) (K112335) | ClearStream Technologies , Ltd. | 2011-10-12 |
| ONSET ACCESS CATHETER SYSTEM (K112629) | Onset Medical Corporation | 2011-10-11 |
| SURESIGNS VS2+ -SURESIGNS VSI (K112652) | Philips Medical Systems | 2011-10-11 |
| HUIBAO BODY FAT SCALE (K111404) | Zhongshan Huibao Weighing Apparatus Co., Ltd. | 2011-10-07 |
| GLOBALCARDIO (K111320) | Cardiocomm Solutions, Inc. | 2011-10-07 |
| ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS) (K103643) | Ascot Technologies, Inc. | 2011-10-06 |
| XL EXTRACTION CATHETER (K112571) | Vascular Solutions, Inc. | 2011-10-06 |
| WILDCAT 5F GUIDEWIRE SUPPORT CATHETER (K112579) | Avinger, Inc. | 2011-10-06 |
| CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2 (K112007) | Biosense Webster, Inc. | 2011-10-05 |
| INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216 (K111905) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011-10-04 |
| CARDIOMED (K103651) | Cardio Medical Products, Inc. | 2011-10-04 |
| PINNACLE PRECISION ACCESS SYSTEM (K111606) | Terumo Medical Corp. | 2011-10-03 |
| MOBICATH TRANSSEPTAL NEEDLE (K111644) | Great Batch Medical | 2011-10-03 |
| ARMADA 35/35LL PTA CATHETER (K111899) | Abbott Vascular | 2011-10-03 |
| DYNAMIC ECG SYSTEM MODEL TLC5000 (K101273) | Contec Medical System Co., Ltd. | 2011-09-30 |
| FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (K112320) | Health & Life Co., Ltd. | 2011-09-30 |
| D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS (K112525) | Parexel International | 2011-09-29 |
| SCEPTER C OCCLUSION BALLOON CATHETER (K110741) | MicroVention, Inc. | 2011-09-29 |
| AGILLS PF DELIVERY SYSTEM (K111943) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2011-09-29 |
| RADIAL ARTERY COMPRESSION TOURNIQUET (K111837) | Lepu Medical Technology (Beijing) Co., Ltd. | 2011-09-27 |
| SELECTRA ACCESSORY KIT (K111839) | Biotronik, Inc. | 2011-09-26 |
| SELECTRA SLITTER TOOL (K112482) | Biotronik, Inc. | 2011-09-26 |
| REPROCESSED ELECTROPHYSIOLOGY CATHETERS (K112232) | Stryker Sustainability Solutions | 2011-09-26 |
| MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS (K111888) | Masimo Corporation | 2011-09-23 |
| RHYTHMVIEW (TM) (K110878) | Topera, Inc. | 2011-09-23 |
| DIGITAL ELECTROCARDIOGRAPH (K112431) | Shenzhen Biocare Electronics Co., Ltd. | 2011-09-22 |
| RADIFORCE LARGE MONITOR SYSTEM (K112645) | Eizo GmbH | 2011-09-22 |
| PULSIOFLEX (K112448) | Pulsion Medical Systems, Inc. | 2011-09-22 |
| TANDEMHEART PUMP (K110493) | Cardiacassist, Inc. | 2011-09-20 |
| SORIN CENTRIFUGAL PUMP 5 (CP5) (K112225) | Sorin Group Deutschland GmbH | 2011-09-20 |
| MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS (K111490) | Ev3, Inc. | 2011-09-16 |
| AVIAFIT (K111720) | Flowmedic , Ltd. | 2011-09-16 |
| QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES (K112360) | Maquet Cardiopulmonary, AG | 2011-09-15 |
| CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (K112372) | Cardiac Assist, Maquet Cardiovascular, LLC | 2011-09-15 |
| VITAL SIGNS MONITOR (K112465) | Advanced Instruments, Inc. | 2011-09-14 |
| AMCOM COMMTECH MESSENGER (K112047) | Amcom Software,Inc. | 2011-09-13 |
| THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETER (K110891) | LeMaitre Vascular, Inc. | 2011-09-13 |
| REKA E100 (K111438) | Reka Pte, Ltd. | 2011-09-12 |
| AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX (K111704) | Avinger, Inc. | 2011-09-09 |
| SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES (K112327) | Cardiac Assist, Maquet Cardiovascular, LLC | 2011-09-09 |
| ASAHI ULTIMATEBROS 3 PTCA GUIDE WIRE (K101986) | Asahi Intecc Co., Ltd. | 2011-09-09 |
| BIOTEQ ANGIOGRAPHIC CATHETER (K102633) | Bioteque Corp. | 2011-09-09 |
| OMNI PATIENT MONITOR (K112329) | Infinium Medical | 2011-09-08 |
| PROSIM 4, PROSIM 6, PROSIM 8 (K110429) | Fluke Biomedical | 2011-09-02 |
| ALP 501 RB PUMP SYSTEM (K112311) | Currie Medical Specialties, Inc. | 2011-09-01 |
| SAPPHIRE NC (K103808) | Orbusneich Medical, Inc. | 2011-09-01 |
| STEERABLE GUIDE CATHETER (K112239) | Abbott Vascular | 2011-08-31 |
| ANGIOSCULPT PTA SCORING BALLOON CATHETER (K112182) | Angioscore, Inc. | 2011-08-26 |
| AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING (K112235) | Airstrip Technologies, LP | 2011-08-26 |
| VESOFLOW (K110977) | Caremed Supply, Inc. | 2011-08-25 |
| MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVERY KIT (K102511) | C.R. Bard, Inc. | 2011-08-24 |
| ECG SERIES ELECTROCARDIOGRAPH (K111805) | Advanced Instrumentations, Inc. | 2011-08-24 |
| NUVANT, MOBILE CARDIAC TELEMETRY (K111917) | Corventis, Inc. | 2011-08-24 |
| THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR (K103706) | Applied Cardiac Systems, Inc. | 2011-08-24 |
| ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE (K110584) | Asahi Intecc Co., Ltd. | 2011-08-22 |
| INBODY (K110689) | Biospace Corporation Limited | 2011-08-19 |
| MICROCATHETER (K112124) | Navilyst Medical, Inc. | 2011-08-19 |
| REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER (K110076) | Sterilmed, Inc. | 2011-08-18 |
| FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM (K111284) | Ostial Corporation | 2011-08-17 |
| CROSSER RECANALIZATION SYSTEM (K112308) | C.R. Bard, Inc. | 2011-08-17 |
| GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDE WIRE 6100-XXXXX, 6100CB-XXXX (K112281) | Trireme Medical, Inc. | 2011-08-17 |
| FIBERNET EMBOLIC PROTECTION DEVICE (K111987) | Lumen Biomedical, Inc. | 2011-08-17 |
| ZOLL E SERIES (K111594) | Zoll Medical Corporation, World Wide Headquarters | 2011-08-17 |
| INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM (K112103) | Boston Scientific Corp | 2011-08-12 |
| WILDCAT CATHETER (K111338) | Avinger, Inc. | 2011-08-11 |
| BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER (K111963) | Bridgepoint Medical | 2011-08-10 |
| SAPPHIRE (K103657) | Orbusneich Medical, Inc. | 2011-08-09 |
| ECG-6 SERIES ELECTROCARDIOGRAPH (K112135) | Advanced Instrumentations, Inc. | 2011-08-05 |
| HEADWAY 27 MICROCATHETER (K110813) | MicroVention, Inc. | 2011-08-05 |
| ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER (K111043) | Boston Scientific Corp | 2011-08-04 |
| TELEMEDCARE HEALTH MONITOR (K103796) | Telemedcare Pty, Ltd. | 2011-08-03 |
| EKOSONIC ENDOVASCULAR SYSTEM (K111705) | Ekos Corporation | 2011-08-03 |
| ANCHORWIRE GUIDEWIRE (K111288) | Lake Region Medical | 2011-08-02 |
| TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR (K103802) | GE Healthcare Finland Oy | 2011-08-02 |
| INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS) (K111160) | Intricon Datrix Corporation | 2011-08-01 |
| A & D MEDICAL UA-1000 FAMILY DAGITAL BLOOD PRESSURE MONITORS (K111686) | A&D Company, Ltd. | 2011-08-01 |