| WITHINGS, SMART BODY SCALE (K121971) | Zhongshan Transtek Electronics Co., Ltd. | 2012-09-27 |
| ELECTRONIC STETHOSCOPE (K121144) | Sharp Corporation | 2012-09-26 |
| ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER (K121219) | Medtronic, Inc. | 2012-09-25 |
| ZOLL R SERIES (K120907) | Zoll Medical Corporation, World Wide Headquarters | 2012-09-25 |
| BLOOD PRESSURE MONITOR WITH STETHOSCOPE (K122259) | Hangzhou Reli-On Co., Ltd. | 2012-09-24 |
| OSTIAL PRO STENT POSITIONING SYSTEM (K122089) | Merit Medical Systems, Inc. | 2012-09-21 |
| AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION) (K120462) | Inovise Medical, Inc. | 2012-09-20 |
| MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS (K120657) | Masimo Corporation | 2012-09-19 |
| MERIT HYDROPHILIC GUIDE WIRE (K120644) | Merit Medical Systems, Inc. | 2012-09-19 |
| PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM (K121917) | Penumbra, Inc. | 2012-09-19 |
| SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS (K122506) | Surefire Medical, Inc. | 2012-09-17 |
| IMAGER II ANGIOGRAPHIC CATHETER (K121694) | Boston Scientific Corp | 2012-09-14 |
| AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE (K100645) | Medtronic, Inc. | 2012-09-14 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS (K121774) | Boston Scientific Corp | 2012-09-13 |
| VISIONS PV .035 DITITAL IVUS CATHETER (K121273) | Volcano Corporation | 2012-09-10 |
| HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX (K122612) | Maquet Cardiovascular, LLC | 2012-09-10 |
| EARLYSENSE CENTRAL DISPLAY SYSTEM (K121885) | Earlysense, Ltd. | 2012-09-10 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K121372) | Andon Health Co, Ltd. | 2012-09-10 |
| MASIMO SET USPO2 PULSE OXIMETRY CABLE (K121914) | Masimo Corporation | 2012-09-07 |
| GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE (K122301) | Vascular Solutions Zerusa , Ltd. | 2012-09-07 |
| TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM (K113821) | Transonic Systems, Inc. | 2012-09-07 |
| SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES (K122628) | Datascope Corp., Cardiac Assist Division | 2012-09-06 |
| FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM (K122379) | Ostial Corporation | 2012-09-05 |
| MOLLRING MULTITASC (K121415) | LeMaitre Vascular, Inc. | 2012-09-05 |
| CVINSIGHT (K120052) | Intelomed, Inc. | 2012-09-04 |
| PINTLER PATIENT WARMING SYSTEM (K113705) | Pintler Medical | 2012-08-31 |
| TYSHAK NUCLEUS (K121859) | NuMED, Inc. | 2012-08-31 |
| EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) (K121196) | Boston Scientific Corp | 2012-08-31 |
| RUBICON 18 SUPPORT CATHETER (K122394) | Boston Scientific Corp | 2012-08-30 |
| INTRODUCER SET, MODEL ADELANTE-S SERIES (K122084) | Oscor, Inc. | 2012-08-29 |
| AZUR DETACHABLE 35 (K122316) | MicroVention, Inc. | 2012-08-29 |
| INTELLIVUE PATIENT MONITOR (K122439) | Philips Medizin Systeme Boeblingen GmbH | 2012-08-29 |
| PADNET 2.0 (K122281) | Biomedix, Inc. | 2012-08-29 |
| ARTISAN EXTEND CONTROL CATHETER (K122275) | Hansen Medical | 2012-08-29 |
| HEM-7200-Z (BP742) (K121932) | Omron Healthcare, Inc. | 2012-08-29 |
| INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR (K122254) | Sorin Group Italia S.R.L. | 2012-08-24 |
| LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM (K111603) | Ep Dynamics, Inc. | 2012-08-23 |
| AMPLATZER TORQVUE FX (K121611) | Aga Medical Corporation | 2012-08-23 |
| EDWARDS PERCUTANEOUS SHEATH INTRODUCER (K121185) | Edwards Lifesciences, LLC | 2012-08-22 |
| INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR (K121536) | Sorin Group Italia S.R.L. | 2012-08-22 |
| VASOPRESS DVT LEG GARMENTS (STERILE) VASOPRESS DVT FOOT GARMENTS (STERILE) (K122179) | Compression Therapy Concepts | 2012-08-20 |
| WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM (K121720) | Welkins, LLC | 2012-08-20 |
| MEDLINE HIGH PRESSURE INJECTION TUBING (K120008) | Medline Industries, Inc. | 2012-08-17 |
| ATRIUM FLIXENE IFG VASCULAR GRAFT (K122138) | Atrium Medical Corp. | 2012-08-17 |
| PRELUDE 7F SHORT SHEATH INTRODUCER (K122190) | Merit Medical Systems, Inc. | 2012-08-17 |
| A-V FOOT PUMP (K121718) | Dalian Labtek Science & Development Co., Ltd. | 2012-08-17 |
| YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH TRANSMISSION (K121025) | Ya Horng Electronic Co., Ltd. | 2012-08-17 |
| CHORD-X EPTFE SUTURE (K121173) | On-Xlifetechnologies | 2012-08-16 |
| VISI MOBILE MONITORING SYSTEM (K122036) | Sotera Wireless, Inc. | 2012-08-15 |
| ARMADA 14XXT PTA CATHETER (K121352) | Abbott Vascular | 2012-08-15 |
| CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G (K122070) | Trireme Medical, Inc. | 2012-08-15 |
| BIOHARNESS (K113045) | Zephyr Technology Corporation | 2012-08-14 |
| CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS (K120158) | Thomas Medical Products, Inc. | 2012-08-14 |
| CONNECTED CARE CLINICAL APPLICATION (K120320) | Watermark Medical, Inc. | 2012-08-14 |
| AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE (K121776) | Codman & Shurtleff, Inc. | 2012-08-14 |
| TABLET COMMANDER (K122285) | Cardiocom, LLC | 2012-08-14 |
| NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL) (K121667) | Boston Scientific Corp | 2012-08-13 |
| SCEPTER C OCCLUSION BALLOON CATHETER (K121785) | MicroVention, Inc. | 2012-08-10 |
| BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT (K121197) | Preventice, Inc. | 2012-08-10 |
| AIMAGO EASYLDI MICROCIRCULATION CAMERA (K121429) | Aimago SA | 2012-08-10 |
| ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR (K120554) | Sejoy Electronics & Instruments Co., Ltd. | 2012-08-10 |
| CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH (K120781) | Fuji Systems Corp. | 2012-08-09 |
| CONVEY GUIDING CATHETER (K120585) | Pendracare International, B.V. | 2012-08-08 |
| UNBALLOON NON-OCCLUSIVE MODELING CATHETER (K121839) | LeMaitre Vascular, Inc. | 2012-08-08 |
| APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH (K121168) | Aptus Endosystems, Inc. | 2012-08-08 |
| KENT CAMERA (K113507) | Kent Imaging, Inc. | 2012-08-08 |
| HEART SYNC PEDIATRIC PHYSIO AED PAD (K120536) | Heart Sync, Inc. | 2012-08-06 |
| REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS (K121158) | Sterilmed, Inc. | 2012-08-06 |
| TREVO RETRIEVER (K120961) | Concentric Medical, Inc. | 2012-08-03 |
| DISITAL BLOOD PRESSURE MONITOR (K112620) | Nihon Seimitsu Sokki Co., Ltd. | 2012-08-02 |
| ELI 280 ELECTROCARDIOGRAPH (K122073) | Mortara Instrument, Inc. | 2012-08-02 |
| MICROLIFE WRIST WATCH BLOOD PREEURE MONITOR, BP3MO1-3P (K120430) | Microlife Intellectual Property GmbH | 2012-08-02 |
| HEADWAY DUO MICROCATHETER (K120917) | MicroVention, Inc. | 2012-08-02 |
| PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE (K122121) | Pulsion Medical Systems SE | 2012-08-02 |
| ORION MICRO CATHETER (K113289) | Micro Therapeutics, Inc. | 2012-08-01 |
| HQS INTRODUCER (K113849) | Alseal | 2012-07-31 |
| PLATO MICROCATH 27 MICROCATHETER (K121734) | Scientia Vascular, LLC | 2012-07-30 |
| XPRESSWAY RX CATHETER (6F LD-VERISON) (K121301) | Kaneka Pharma America, LLC | 2012-07-30 |
| SENSICARDIAC (K121617) | Diacoustic Medical (Pty) | 2012-07-27 |
| THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL (K121748) | Access Scientific, Inc. | 2012-07-27 |
| INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVIOR (K121909) | Sorin Group Italia S.R.L. | 2012-07-26 |
| CAREGUIDE OXIMETER (K113656) | Reflectance Medical, Inc. | 2012-07-26 |
| ICP TRIAGEMANAGER (K122095) | Emergo Europe Consulting BV | 2012-07-26 |
| ORIGEN REINFORCED DUAL LUMEN CATHETER (K113869) | Origen Biomedical, Inc. | 2012-07-26 |
| WI-FI BODY SCALE (K120896) | Andon Health Co, Ltd. | 2012-07-26 |
| CONNEX VITAL SIGNS MONITOR 6000 SERIES (K121013) | Welch Allyn, Inc. | 2012-07-26 |
| DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT (K120988) | Medtronic, Inc. | 2012-07-25 |
| E1 EAR SENSORS (K121912) | Masimo Corporation | 2012-07-24 |
| COMPRESSION CARE FLIGHT (K121376) | Medical Minds, LLC | 2012-07-24 |
| INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY (K121229) | Sorin Group Italia S.R.L. | 2012-07-23 |
| SLIDEWIRETM(TRADEMARK PENDING) (K113162) | Acme-Monaco Corp. | 2012-07-20 |
| DISPOSABLE TORQUE DEVICE (K113498) | Coeur, Inc. | 2012-07-20 |
| HYBRID ARCTICGEL PAD (K120849) | Medivance, Inc. | 2012-07-20 |
| HANDHELD ECG MONITOR (K112622) | Beijing Choice Electronic Technololgy Co., Ltd. | 2012-07-19 |
| CORPATH 200 SYSTEM (K120834) | Corindus, Inc. | 2012-07-19 |
| RSCRIBE ELECTROCARDIOGRAPH (K120865) | Mortara Instrument, Inc. | 2012-07-19 |
| PROCARE MONITOR B40 (K120598) | Ge Medical Systems China Co., Ltd. | 2012-07-19 |
| INTELLIVUE PATIENT MONITOR (K120366) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2012-07-18 |
| WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR (K121355) | Sejoy Electronics & Instruments Co., Ltd. | 2012-07-18 |
| ZIO PATCH (K121319) | iRhythm Technologies, Inc. | 2012-07-18 |