| PULSE OXIMETER (K112843) | Nonin Medical, Inc. | 2012-04-19 |
| WHOLEY GUIDE WIRE SYSTEM (K120863) | Covidien, LLC | 2012-04-19 |
| MANTARAY GUIDEWIRES (K120881) | Bridgepoint Medical | 2012-04-18 |
| INZONE DETACHMENT SYSTEM (K120816) | Stryker | 2012-04-17 |
| COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002) (K121001) | Novitas Medical, LLC | 2012-04-17 |
| FLEXITOUCH SYSTEM (K120972) | Tactile Systems Technology, Inc. | 2012-04-13 |
| PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE (K120805) | Angioslide, Ltd. | 2012-04-13 |
| TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT (K112398) | Galt Medical | 2012-04-12 |
| ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT (K120774) | Welch Allyn, Inc. | 2012-04-10 |
| SONIXGPS VASCULAR ACCESS NEEDLE KIT (K120349) | Ultrasonix Medical Corpation | 2012-04-09 |
| WEIGHT AND BODY FAT SCALE SHINE BS0105 (K112149) | Shine Overseas Marketing Limited | 2012-04-09 |
| INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR (K113626) | Sorin Group Italia S.R.L. | 2012-04-05 |
| EAGLE EYE PLATINUM ST CATHETER (K120697) | Volcano Corporation | 2012-04-05 |
| PAGEWRITER TC 20, 30, 50, 70 (K113144) | Philips Medical Systems | 2012-04-03 |
| ENCORE 26 ADVANTAGE KIT (K120694) | Boston Scientific Corp | 2012-04-03 |
| REPROCESSED FEMORAL COMPRESSION DEVICE (K120204) | Sterilmed, Inc. | 2012-04-03 |
| MEDLINE STOPCOCK AND MANIFOLD (K120069) | Medline Industries, Inc. | 2012-04-03 |
| CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R) VENA CAVA FILTER FOR FEMORAL APPROACH (K112119) | William Cook Europe Aps | 2012-03-30 |
| ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS (K112452) | AngioDynamics, Inc. | 2012-03-30 |
| KITTYCAT CATHETER, KITTYCAT 2 CATHETER (K120273) | Avinger, Inc. | 2012-03-30 |
| FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM (K120738) | Ostial Corporation | 2012-03-29 |
| SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390 (K120616) | Spacelabs Medical, Inc. | 2012-03-29 |
| IMAGER II ANGIOGRAPHIC CATHETERS (K120893) | Boston Scientific Corp | 2012-03-29 |
| AZUR DETACHABLE 18 (K120630) | MicroVention, Inc. | 2012-03-28 |
| INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET (K113798) | Draeger Medical Systems, Inc. | 2012-03-22 |
| PHYSIOLOGICAL MONITOR, PATIENT MONITOR (K113441) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2012-03-22 |
| EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) (K113220) | Boston Scientific Corporation | 2012-03-22 |
| EZSLEEP SLEEP QUALITY RECORDER (K112573) | Platinum Team Co., Ltd. | 2012-03-22 |
| VISI MOBILE MONITORING SYSTEM (K112478) | Sotera Wireless, Inc. | 2012-03-22 |
| INTELLIVUE PATIENT MONITOR (K113657) | Philips Medizin Systeme Boblingen GmbH | 2012-03-22 |
| ZOLL X SERIES (K112432) | Zoll Medical Corporation, World Wide Headquarters | 2012-03-21 |
| PULTOL (K113865) | Sharp Corporation | 2012-03-21 |
| UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR (K112887) | Upstream Peripheral Technologies | 2012-03-21 |
| M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER (K112100) | Vascular Solutions, Inc. | 2012-03-20 |
| RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN (K120544) | St Jude Medical | 2012-03-19 |
| FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF) (K113239) | Health & Life Co., Ltd. | 2012-03-16 |
| V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM (K113811) | C.R. Bard Inc., Bard Electrophysiology Division | 2012-03-16 |
| HORIZON CARDIOLOGY ECG MANAGEMENT (K113515) | Mckesson Israel , Ltd. | 2012-03-16 |
| GORE(R) EMBOLIC FILTER (K120480) | W.L. Gore & Associates | 2012-03-16 |
| ELECTROCARDIOGRAPH (K120188) | Edan Instruments, Inc. | 2012-03-16 |
| AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 (K112998) | Zoll Circulation | 2012-03-15 |
| AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AMPLATZER TORQVUE LA1 DELIVERY SHEATH AMPLATZER TORQVUE LA2 SELIVERY SHEATH (K120120) | Aga Medical Corporation | 2012-03-15 |
| CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014) (K120677) | Trireme Medical, Inc. | 2012-03-15 |
| CONQUEST 40 PTA DILATATION CATHETER (K120660) | Bard Peripheral Vascular, Inc. | 2012-03-15 |
| CONCENTRIC BALLOON GUIDE CATHETER (K112404) | Concentric Medical, Inc. | 2012-03-15 |
| WILDCAT CATHETER (K113838) | Avinger, Inc. | 2012-03-12 |
| MODIFIED CONCENTIRC MICROCATHETER (K113260) | Concentric Medical, Inc. | 2012-03-09 |
| NUVANT, MOBILC CARDIAC TELEMETRY (K113372) | Corventis, Inc. | 2012-03-07 |
| NC TREK OTW CORONARY DILATATION CATHETER (K113464) | Abbott Vascular | 2012-03-06 |
| ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE) (K113264) | Ld Technology, LLC | 2012-03-02 |
| GLIDER PTCA BALLOON CATHETER (K111544) | Trireme Medical, Inc. | 2012-03-02 |
| PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER (K113584) | St Jude Medical | 2012-03-02 |
| SOLITAIRE FR REVASCULARIZATION DEVICE (K113455) | Micro Therapeutics Dba Ev3 Neurovascular | 2012-03-02 |
| FULL AUTOMATIC (NIBP) BLOOD PRESSUE MONITOR (K113238) | Health & Life Co., Ltd. | 2012-03-01 |
| E-PASS (K113148) | Synexmed(Shenzhen)Company Limited | 2012-02-28 |
| BLOOD PRESSURE MONITOR (K112690) | Nihon Seimitsu Sokki Co., Ltd. | 2012-02-24 |
| JETSTREAM NAVITUS L SYSTEM (K120242) | Pathway Medical Technologies, Inc. | 2012-02-24 |
| BLOOD PRESSURE MONITOR (K112691) | Nihon Seimitsu Sokki Co., Ltd. | 2012-02-24 |
| MASIMO SET REUSABLE OXIMETRY SENSORS (K113596) | Masimo Corporation | 2012-02-24 |
| 14 WIRE STANDARD, 14 WIRE LS (K113454) | Micro Therapeutics, Inc. | 2012-02-24 |
| ENVOY DISTAL ACCESS GUIDING CATHETER (K120229) | Codman & Shurtleff, Inc. | 2012-02-24 |
| Q50 PLUS STENT GRAFT BALLOON CATHETER (K120381) | Qxmedical, LLC | 2012-02-24 |
| CONNEX WORKSTATION (K120343) | Welch Allyn, Inc. | 2012-02-24 |
| MEDIGUIDE TECHNOLOGY (K120301) | St. Jude Medical, Mediguide Navigation Systems | 2012-02-24 |
| UPSTREAM SUPPORT CATHETER (K112886) | Upstream Peripheral Technologies | 2012-02-23 |
| SUREFIRE GUIDE SHEATH (K113737) | Surefire Medical, Inc. | 2012-02-23 |
| ASPIRE MAX ASPIRATION CATHETER (K113757) | Control Medical Technology, LLC | 2012-02-22 |
| SMARTHEART (K113514) | Shl Telemedicine International , Ltd. | 2012-02-22 |
| BOKANG SEMI-AUTO / AUTOMATIC / WRIST DIGITAL BLOOD PRESSURE MONITOR (K111141) | Wenzhou Bokang Instruments Co., Ltd. | 2012-02-21 |
| EQUIVITAL (K113054) | Hidalgo Limited | 2012-02-17 |
| NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS (K120081) | Cincinnati Sub-Zero Products, Inc. | 2012-02-17 |
| PLEURX PLEURAL CATHETER SYSTEMS (K112831) | Care Fusion | 2012-02-16 |
| PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES (K110825) | Philips Medical Systems | 2012-02-16 |
| VICTORY GUIDEWIRE (32 MODELS) (K120137) | Brivant, Ltd. | 2012-02-14 |
| VITAL SIGNS MONITOR (K120144) | Edan Instruments, Inc. | 2012-02-14 |
| SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 VITAL SIGNS MONITOR (K120132) | Philips Medical Systems | 2012-02-14 |
| KINGYIELD WRIST BLOOD PRESSURE MONITOR (K112042) | Shenzhen Kingyield Technology Co., Ltd. | 2012-02-10 |
| PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500 (K113183) | Shanghai 3f Electronics Co, Ltd. | 2012-02-09 |
| AFX INTRODUCER SYSTEM (K120212) | Endologix, Inc. | 2012-02-09 |
| SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS (K112407) | Smiths Medical MD, Inc. | 2012-02-09 |
| IM BAND (K113600) | Synexmed(Shenzhen)Company Limited | 2012-02-08 |
| WINGMAN EXTENDABLE TIP SUPPORT CATHETER (K120178) | Reflow Medical | 2012-02-08 |
| TLINK DATA MANAGEMENT SYSTEM (DMS) (K113214) | Terumo Cardiovascular Systems Corp. | 2012-02-07 |
| Z FLEX-270TM STEERABLE SHEATH (K112541) | Great Batch Medical | 2012-02-07 |
| PATIENT MONITOR (K113653) | Edan Instruments, Inc. | 2012-02-06 |
| ZIO PATCH (K113862) | iRhythm Technologies, Inc. | 2012-02-06 |
| VASCULAR SONO (K113196) | PAJUNK GmbH Medizintechnologie | 2012-02-06 |
| ASAHI CHIKAI V PERIPHERAL VASCULAR GUIDE WIRE (K113716) | Asahi Intecc Co., Ltd. | 2012-02-06 |
| MANTARAY CATHETER (K120129) | Bridgepoint Medical | 2012-02-03 |
| HERO GRAFT (K120006) | Hemosphere, Inc. | 2012-02-02 |
| RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT (K110051) | Great Batch Medical | 2012-02-02 |
| MINI-MEDIC (K113165) | Athena Gtx | 2012-02-02 |
| CONNEXALL SUITE OF SOFTWARE PRODUCTS (K112650) | Connexall USA, Inc. | 2012-02-01 |
| PATIENT MONITOR (K113623) | Edan Instruments, Inc. | 2012-02-01 |
| ACTIVECARE DVT ACTIVECARE+SFT (K113525) | Medical Compression Systems (Dbn) , Ltd. | 2012-01-31 |
| TRANSTEK BLOOD PRESSURE MONITOR (K120058) | Zhongshan Transtek Electronics Co., Ltd. | 2012-01-31 |
| MODEL HBP-1300 (K113185) | Omron Healthcare, Inc. | 2012-01-27 |
| FINGERTIP PULSE OXIMETER (K112804) | Guangdong Biolight Meditech Co., Ltd. | 2012-01-27 |
| CALG-STR EXERCISE ECG ANALYSIS ALGORITHM (K112959) | Philips Health Care | 2012-01-26 |
| FORE-SIGHT ABSOLUTE TISSUE OXIMETER (K112820) | Cas Medical Systems, Inc. | 2012-01-26 |