| TRACKER-17 MICROCATHER, 150 CM LONG AND 15.0 CM FLEXIBLE DISTAL SHAFT, TRACKER-17 MICROCATHETER, 150 CM LONG AND 7.5 CM (K123452) | Stryker | 2013-01-03 |
| DOPPLEX ABILITY (K121108) | Huntleigh Healthcare | 2013-01-03 |
| FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) (K123591) | Medtronic Cryocath, LP | 2012-12-27 |
| TRANSTEK WRIST BLOOD PRESSURE MONITOR (K123669) | Zhongshan Transtek Electronics Co., Ltd. | 2012-12-21 |
| NHANCER (K121077) | Imds Operations B.V. | 2012-12-21 |
| VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003; VASCULAIRE SLEEVE (FOOT & CALF) MODEL FLS-0002; VASCULAIRE SLEEVE (CALF) F (K122609) | Venous Health Systems, Inc. | 2012-12-21 |
| REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER (K121913) | Stryker Sustainability Solutions, Inc. | 2012-12-20 |
| OXICARE FINGERTIP PULSE OXIMETER (K122927) | Delbio Incorporated | 2012-12-20 |
| HEALTHVIEW ECG MANAGER (K123466) | Lumedx | 2012-12-20 |
| BASIXCONPAK ANALOG INFLATION SYRINGE (K122321) | Merit Medical Ireland, Ltd. | 2012-12-19 |
| MOBICATH TRANSSEPTAL NEEDLE (K122832) | Great Batch Medical | 2012-12-19 |
| HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM (K122813) | Cincinnati Sub-Zero Products, Inc. | 2012-12-18 |
| OXTI INFLATION DEVICE (K122152) | Oxti Corporation | 2012-12-14 |
| OCELOT PIXL CATHETER (K123532) | Avinger, Inc. | 2012-12-14 |
| SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX) (K122937) | Cook, Inc. | 2012-12-14 |
| UNBALLOON NON-OCCLUSIVE MODELING CATHETER (K123531) | LeMaitre Vascular, Inc. | 2012-12-14 |
| AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB811 (K122827) | Medtronic, Inc. | 2012-12-14 |
| GORE FLOW REVERSAL SYSTEM MODEL GFRS073 (K123156) | W. L. Gore & Associates, Inc. | 2012-12-13 |
| AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE (K123448) | Medtronic, Inc. | 2012-12-13 |
| DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY (K122958) | Oscor, Inc. | 2012-12-13 |
| DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES (K121853) | Defibtech, LLC | 2012-12-13 |
| CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF) (K121398) | Guidepath Medical, Inc. | 2012-12-13 |
| ZOLL SUREPOWER SINGLE BAY CHARGER (K122839) | ZOLL Medical Corporation | 2012-12-13 |
| STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO (K122960) | Oscor, Inc. | 2012-12-13 |
| CARDIOSCOPE (K121266) | Pulsecor Limited | 2012-12-11 |
| GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ (K122980) | Terumo Medical Corporation | 2012-12-11 |
| TL-300 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM (K123446) | United States Gtm Medical Devices, Inc. | 2012-12-07 |
| REVERSE MEDICAL MICROCATHETER (K122684) | Reverse Medical Corporation | 2012-12-07 |
| PC-60NW FINGERTIP OXIMETER (K120502) | Shenzhen Creative Industry Co., Ltd. | 2012-12-07 |
| SMI CARDIOVASCULAR PATCH (K122105) | Solinas Medical, Inc. | 2012-12-07 |
| AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE (K122760) | Medtronic, Inc. | 2012-12-07 |
| OCELOT CATHETER (K123462) | Avinger, Inc. | 2012-12-07 |
| FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE (K122330) | Arjohuntleigh Polska SP Z.O.O. | 2012-12-07 |
| QT GUARD PLUS ANALYSIS SYSTEM (K120770) | Ge Medical Systems Information Technologies | 2012-12-06 |
| MOBILE CAREGUIDE 2100 OXIMETER (K122645) | Reflectance Medical, Inc. | 2012-12-05 |
| MERIT ONE SNARE SYSTEM (K122088) | Merit Medical Systems, Inc. | 2012-12-05 |
| SOLITAIRE 2 REVASCULARIZATION DEVICE (K123378) | Micro Therapeutics Dba Ev3 Neurovascular | 2012-11-30 |
| BLIP MODEL BP-700WF (K123020) | Carematix, Inc. | 2012-11-28 |
| AZUR CX DETACHABLE 18 (K123384) | MicroVention, Inc. | 2012-11-28 |
| SEAL ONE (K123035) | Perouse Medical | 2012-11-28 |
| SJM CONFIRM (K122161) | St Jude Medical | 2012-11-28 |
| AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 (K122543) | MicroVention, Inc. | 2012-11-28 |
| MULTICROSS SUPPORT CATHETER (K121763) | Roxwood Medical, Inc. | 2012-11-27 |
| MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254 (K122581) | Concentric Medical, Inc. | 2012-11-21 |
| AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES (K122488) | Catheter Robotics, Inc. | 2012-11-20 |
| CDI BLOOD PARAMETER MONITORING SYSTEM 500 (K123039) | Terumo Cardiovascular Systems Corp. | 2012-11-20 |
| PENUMBRA DDC CATHETERS (K122772) | Penumbra, Inc. | 2012-11-20 |
| ZOLL RESCUENET 12-LEAD (K121865) | ZOLL Medical Corporation | 2012-11-20 |
| UFIT TEN-10 (K122443) | Biosign Technologies, Inc. | 2012-11-20 |
| REMOTE PRESENCE SYSTEM, MODEL RP-VITA (K123229) | Intouch Health, Inc. | 2012-11-20 |
| HI-TORQUE COMMAND GUIDE WIRE FAMILY (K122573) | Abbott Vascular, Inc. | 2012-11-20 |
| GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING (K121234) | W. L. Gore & Associates, Inc. | 2012-11-20 |
| AIRSTRIP RPM FOR LIFENET CONSULT (K121712) | Airstrip Technologies, Inc. | 2012-11-20 |
| PTFE SUPER SHEATH INTRODUCER (K120617) | Martech Medical Products | 2012-11-19 |
| ALIVECOR HEART MONITOR FOR IPHONE (K122356) | AliveCor, Inc. | 2012-11-19 |
| MOBILECARE MONITOR (K122333) | Aframe Digital, Inc. | 2012-11-19 |
| SPHYGMOCOR XCEL (K122129) | Atcor Medical | 2012-11-16 |
| SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (K122090) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2012-11-15 |
| ZOEFLUID STATUS MONITOR (MODEL ZOE 2B) (K112830) | Noninvasive Medical Technologies, Inc. | 2012-11-13 |
| ENCORE 26 ADVANTAGE KIT (K123214) | Boston Scientific Corp | 2012-11-13 |
| AIR-BAND RADIAL COMPRESSION DEVICE (K122405) | Datascope Corp., Cardiac Assist Division | 2012-11-09 |
| ALN OPTIONAL VANA CAVA FILTER (K113124) | Aln Implants Chirurgicaux | 2012-11-09 |
| STINGRAY GUIDEWIRES (K122795) | Bridgepoint Medical | 2012-11-08 |
| CLEARLUMEN THROMBECTOMY SYSTEM (K120508) | Walk Vascular, LLC | 2012-11-07 |
| OCELOT SYSTEM (K122380) | Avinger, Inc. | 2012-11-07 |
| COMEN MULTI-PARAMETER PATIENT MONITOR (K112877) | Goldway (Us), Inc. | 2012-11-07 |
| FLEXIPORT ECOCUFF (K122058) | Welch Allyn, Inc. | 2012-11-05 |
| TAMARIN BLUE PTCA RX DILATATION CATHETER (K112735) | Natec Medical , Ltd. | 2012-11-02 |
| TANGO M2 BLOOD PRESSURE MONITOR (K122401) | Suntech Medical, Inc. | 2012-11-02 |
| BARD PTV DILATATION CATHETER (K122367) | C.R. Bard, Inc. | 2012-11-02 |
| EXTENDED LIFE BATTERY (K120350) | Aed Battery Exchange, LLC | 2012-11-01 |
| MODIFIED TREVO RETRIEVER (K122478) | Concentric Medical, Inc. | 2012-10-31 |
| TORQUE DEVICE (K123024) | Boston Scientific Corporation | 2012-10-26 |
| ZOLL FULLY AUTOMATIC AED PLUS (K120406) | Zoll Medical Corporation, World Wide Headquarters | 2012-10-26 |
| STEALTH 360 ORBITAL PAD SYSTEM (K122987) | Cardiovascular Systems, Inc. | 2012-10-25 |
| DIGITAL ELECTROCARDIOGRAPH (K122712) | Shenzhen Biocare Electronics Co., Ltd. | 2012-10-25 |
| HX-461 (K120545) | Seers Technology Co., Ltd. | 2012-10-23 |
| CPRMETER CPR FEEDBACK DEVICE (K122050) | Laerdal Medical A/S | 2012-10-22 |
| TRANSTEK WRIST BLOOD PRESSURE MONITOR (K122482) | Zhongshan Transtek Electronics Co., Ltd. | 2012-10-22 |
| ATLAS GOLD PTA DILATATION CATHETER (K122984) | C.R. Bard, Inc. | 2012-10-22 |
| AFFINITY FUSION RECIRCULATION LINE MODEL RCL841 (K122913) | Medtronic, Inc. | 2012-10-19 |
| PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B (K121962) | Mego Afek AC , Ltd. | 2012-10-19 |
| JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM (K122916) | Medrad, Inc. | 2012-10-19 |
| PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE (K121849) | Care Fusion | 2012-10-18 |
| AIRCAST VENAFLOW ELITE SYSTEM (K122499) | Djo, LLC | 2012-10-18 |
| INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL RESERVOIR (K122844) | Sorin Group Italia S.R.L. | 2012-10-17 |
| CHARTER GUIDEWIRE (K122856) | Brivant, Ltd. | 2012-10-17 |
| FINGERTIP PULSE OXIMETER (K121697) | Andon Health Co, Ltd. | 2012-10-15 |
| CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE (K122811) | Medtronic, Inc. | 2012-10-12 |
| LIFEPAK 1000 DEFIBRILLATOR (K122600) | Physio-Control, Inc. | 2012-10-11 |
| CXI SUPPORT CATHETER (K122796) | Cook, Inc. | 2012-10-11 |
| FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1 (K122178) | Ostial Corporation | 2012-10-11 |
| TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA (K121083) | Loma Vista Medical | 2012-10-11 |
| ESA620 ELECTRICAL SAFETY ANALYZER (K121722) | Fluke Biomedical | 2012-10-11 |
| NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR (K112826) | Moor Instruments, Ltd. | 2012-10-10 |
| Z-MED Z-MED II (K122012) | NuMED, Inc. | 2012-10-04 |
| SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF (K120125) | Ge Medical Systems Information Technologies, Inc. | 2012-10-03 |
| AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING (K122133) | Airstrip Technologies, LP | 2012-10-02 |
| BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE (K121806) | Covidien | 2012-09-28 |
| SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS (K121504) | Togo Medikit Co., Ltd. | 2012-09-27 |