| CONNECTED CARE MOBILE APPLICATION (K120325) | Watermark Medical | 2012-07-18 |
| ST80I STRESS TEST SYSTEM (K121638) | Philips Health Care | 2012-07-18 |
| NMI MICROCATHETER (K121954) | Navilyst Medical, Inc. | 2012-07-17 |
| HEARTRAIL III GUIDING CATHETER (K113335) | Terumo Corporation | 2012-07-16 |
| VIGNET TELEHEALTH MANAGER (K113446) | Vignet, Inc. | 2012-07-16 |
| ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS) (K120253) | Elcam Medical Acal | 2012-07-16 |
| CARDIO 7 (K113306) | Bionet Co., Ltd. | 2012-07-16 |
| CRUX VENA CAVA FILTER SYSTEM (K120402) | Crux Biomedical | 2012-07-13 |
| MANTARAY GUIDEWIRES (K121745) | Bridgepoint Medical | 2012-07-13 |
| ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION (K121856) | C.R. Bard, Inc. | 2012-07-11 |
| MONGOOSE ANGIOGRAPHIC CATHETER (K113819) | Pediacath, Inc. | 2012-07-11 |
| NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM (K120773) | Covidien, LLC | 2012-07-10 |
| NAVIS TORQUER (K112674) | Navis Medical,Inc | 2012-07-06 |
| CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM (K120941) | Constant Care, LLC | 2012-07-03 |
| AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING (K121871) | Airstrip Technologies, LP | 2012-07-03 |
| COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPR (K121629) | William Cook Europe Aps | 2012-07-03 |
| U-RIGHT TD-3124 BLOOD PRESSURE MONITORING SYSTEM (K120634) | Taidoc Technology Corporation | 2012-07-03 |
| WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS) (K121669) | Cincinnati Sub-Zero Products, Inc. | 2012-07-03 |
| PERICAM PSI (K120884) | Perimed AB | 2012-07-03 |
| STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO (K120459) | Oscor, Inc. | 2012-06-29 |
| FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM (K121175) | Ostial Corporation | 2012-06-29 |
| ANY VIEW PATIENT MONITORS (K120193) | Guangdong Biolight Meditech Co., Ltd. | 2012-06-29 |
| FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MM (K113775) | Ostial Corporation | 2012-06-29 |
| ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA ANTEGRADE CATHETER WITH DURAFLO COATING (K113459) | Edwards Lifesciences, LLC | 2012-06-29 |
| INTELLISPACE ECG (K120855) | Philips Health Care | 2012-06-29 |
| WI-FI BODY SCALE (K121527) | Shenzhen Healthcare Electronic Technology Co., Ltd. | 2012-06-28 |
| DATACAPTOR SYSTEM (K113835) | Capsule Tech, Inc. | 2012-06-27 |
| EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE (K120780) | Edwards Lifesciences, LLC | 2012-06-27 |
| GLIDER PTCA BALLOON CATHETER (K121681) | Trireme Medical, Inc. | 2012-06-26 |
| HERO GRAFT (K121532) | Hemosphere, Inc. | 2012-06-22 |
| TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER (K121222) | Abbott Vascular | 2012-06-22 |
| AXERA ACCESS SYSTEM (K121521) | Arstasis, Inc. | 2012-06-21 |
| ZOLL PROPAQ XM (K121367) | ZOLL Medical Corporation | 2012-06-21 |
| SUREFIRE HI-FLOW MICROCATHETER (K121677) | Surefire Medical, Inc. | 2012-06-14 |
| FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR (K121470) | Andon Health Co, Ltd. | 2012-06-14 |
| SYNTHES SCOUT TACK FIXATION (K111048) | Synthes Spine | 2012-06-14 |
| POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER (K121442) | Cordis Corporation | 2012-06-14 |
| VECTOR (K121385) | R4 Vascular, Inc. | 2012-06-14 |
| KODAMA INTRAVASCULAR ULRASOUND CATHETER (K113008) | Silicon Vally Medical Instruments, Inc. | 2012-06-14 |
| EXPRESSION INFORMATION PORTAL (K121424) | Invivo Corporation | 2012-06-13 |
| CONCIERGE GUIDING CATHETER (K121051) | Merit Medical Systems, Inc. | 2012-06-13 |
| AMPLATZER VASCULAR PLUG 4 (K113658) | Aga Medical Corp. | 2012-06-12 |
| RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARME (K121145) | Renu Medical, Inc. | 2012-06-12 |
| AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES (K113628) | Catheter Robotics, Inc. | 2012-06-12 |
| EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA (K113411) | Edwards Lifesciences, LLC | 2012-06-11 |
| NUCLEUS-X PTV CATHETER (DEN080015) | NuMED, Inc. | 2012-06-11 |
| MIPAL (K120470) | Watermark Medical | 2012-06-08 |
| ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT) (K120624) | Elcam Medical Acal | 2012-06-08 |
| CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018' G (K121402) | Trireme Medical, Inc. | 2012-06-08 |
| PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE (K120164) | Angioslide, Ltd. | 2012-06-08 |
| EXPORT XT CATHETER, EXPORT AP CATHETER (K120808) | Medtronic, Inc. | 2012-06-07 |
| ARIATELE TELEMETRY TRANSMITTER (96281) (K121480) | Spacelabs Healthcare | 2012-06-06 |
| DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF (K120987) | Medtronic, Inc. | 2012-06-06 |
| ANGIOJET SOLENT DISTA THROMBECTOMY SET (K113363) | Medrad, Inc. | 2012-06-06 |
| KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR (K120672) | Andon Health Co, Ltd. | 2012-06-01 |
| CLEANER ROTATIONAL THROMBECTOMY SYSTEM (K120346) | Rex Medical | 2012-06-01 |
| KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER (K120944) | Covidien | 2012-05-31 |
| TANDEMHEART FEMORAL ARTERIAL CANNULA SET (K120543) | Cardiacassist, Inc. | 2012-05-30 |
| SOLOHEALTH STATION (K113402) | Solohealth, Inc. | 2012-05-30 |
| HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER (K111004) | Hansen Medical, Inc. | 2012-05-29 |
| MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT (K120612) | Medtronic, Inc. | 2012-05-25 |
| UPSTREAM GR CATHETER (K120964) | Upstream Peripheral Technologies | 2012-05-25 |
| PATIENT MONITOR (K120631) | Advanced Instruments, Inc. | 2012-05-25 |
| PENTARAY NAV HIGH-DENSITY MAPPING CATHETER (K120425) | Biosense Webster, Inc. | 2012-05-24 |
| REMOTE PRESENCE SYSTEM (K120895) | Intouch Health, Inc. | 2012-05-24 |
| BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES (K120533) | Bridgepoint Medical | 2012-05-22 |
| SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE (K113103) | Rex Medical | 2012-05-22 |
| AMPHIRION PLUS PTA CATHETER (K121265) | Medtronic, Inc. | 2012-05-22 |
| IMPULSE AND EXPO ANGIOGRAPHIC CATHETER (K120495) | Boston Scientific Corp | 2012-05-21 |
| HEARTCHECK ECG PEN WITH GEMS HOME (K121009) | Cardiocomm Solutions, Inc. | 2012-05-17 |
| PATIENT MONITOR (K120173) | Edan Instruments, Inc. | 2012-05-16 |
| MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM (K112921) | Medicalgorithmics S.A. | 2012-05-16 |
| SWITCH-IT CATHETER (K120707) | Vascular Solutions, Inc. | 2012-05-15 |
| TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM (K121141) | Tensys Medical Systems, Inc. | 2012-05-15 |
| GEL-BLOCK EMBOLIZATION PLEDGETS (K113266) | Vascular Solutions, Inc. | 2012-05-14 |
| MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY (K113215) | Nonin Medical, Inc. | 2012-05-14 |
| SUNMED GUIDE WIRE (K120119) | Sunny Medical Device (Shenzhen) Co., Ltd. | 2012-05-11 |
| CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER (K120296) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2012-05-11 |
| INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CARDIOTOMY RESERVIOR (K120185) | Sorin Group Italia S.R.L. | 2012-05-11 |
| POCKETCPR (K112660) | Zoll Medical Corp | 2012-05-10 |
| CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE (K120298) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2012-05-08 |
| TERUMO PALL AL20X ARTERIAL FILTER (K121209) | Terumo Cardiovascular Systems Corporation | 2012-05-08 |
| VENOUS DRAINAGE CANNULA WITH DURAFLO COATING (K120072) | Edwards Lifesciences, LLC | 2012-05-08 |
| CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD) (K120550) | Biosense Webster, Inc. | 2012-05-07 |
| EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (K121015) | Abbott Vascular | 2012-05-04 |
| COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS (K121057) | William Cook Europe Aps | 2012-05-04 |
| UNIMED DISPOSABLE BLOOD PRESSURE CUFF (K120364) | Unimed Medical Supplies, Inc. | 2012-05-04 |
| POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER (K112797) | Cordis Corp. | 2012-05-04 |
| 3M LITTMANN TELESTETH ONLINE AUSCULATION SYSTEM (K120704) | 3M Company | 2012-05-03 |
| ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER (K121006) | St Jude Medical | 2012-05-03 |
| VITAL SIGNS MONITOR (K113833) | Guangdong Biolight Meditech Co., Ltd. | 2012-05-01 |
| K2 MEDICAL VASCULAR CLAMPS (K120492) | K2 Medical GmbH & Co. KG | 2012-04-30 |
| ELECTROCARDIOGRAPH (K113485) | Shenzhen Carewell Electronics Co., Ltd. | 2012-04-25 |
| ZOLL PROPAQ MD (K112761) | Zoll Medical Corporation, World Wide Headquarters | 2012-04-25 |
| CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM (K120086) | Cardiosolutions | 2012-04-24 |
| EXCELSIOR XT-27 MICROCATHETER (K113778) | Stryker Neurovascular | 2012-04-20 |
| MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER (K120868) | Datascope Corp., Cardiac Assist Division | 2012-04-20 |
| GORE DRYSEAL SHEATH (K120428) | W. L. Gore & Associates, Inc. | 2012-04-20 |
| RIVAL PTA DILATATION CATHETER (K120722) | Bard Peripheral Vascular, Inc. | 2012-04-19 |
| ATLAS PTA BALLOON DILATATION CATHETER (K120971) | Bard Peripheral Vascular, Inc. | 2012-04-19 |