| AXERA 2 ACCESS SYSTEM (K123618) | Arstasis, Inc. | 2013-03-24 |
| PROCARE MONITOR B20 (K122253) | Ge Medical Systems China Co., Ltd. | 2013-03-22 |
| MORTARA SURVEYOR PATIENT MONITOR (K123556) | Mortara Instrument, Inc. | 2013-03-22 |
| FEMORAL ACCESS VENOUS CANNULAE (K123303) | Edwards Lifesciences, LLC | 2013-03-22 |
| BP652N (HEM-6300-Z) (K123498) | Omron Healthcare, Inc. | 2013-03-21 |
| APPS-HEALTH01 (K122098) | Andon Health Co, Ltd. | 2013-03-21 |
| SHENZHEN MED-LINK PULSE OXIMETER PROBE (K113727) | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2013-03-21 |
| INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR, INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATE (K130433) | Sorin Group Italia S.R.L. | 2013-03-20 |
| CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER (K130257) | St Jude Medical | 2013-03-20 |
| LIDCORAPID V2 MONITOR (K122247) | Lidco, Ltd. | 2013-03-20 |
| CPS AIM UNIVERSAL SLITTABLE INNER CATHETER (K130252) | St Jude Medical | 2013-03-20 |
| VIA MICROCATHETER, VIA PLUS MICROCATHETER (K123477) | Sequent Medical, Inc. | 2013-03-19 |
| AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE (K123351) | Medtronic Perfusion Systems | 2013-03-19 |
| GUIDEZILLA GUIDE EXTENSION CATHETER (K123765) | Boston Scientific | 2013-03-19 |
| ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3 (K122940) | Cook, Inc. | 2013-03-19 |
| FLIXENE IFG VASCULAR GRAFT (K130142) | Atrium Medical Corporation | 2013-03-15 |
| TVC IMAGING SYSTEM MODEL NIRS-MC7-70 (K123108) | Infraredx, Inc. | 2013-03-15 |
| FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING (K123298) | Edwards Lifesciences, LLC | 2013-03-15 |
| CATALYST II AND III (K130124) | Cardiva Medical, Inc. | 2013-03-14 |
| EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA (K123370) | Edwards Lifesciences, LLC | 2013-03-13 |
| CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR (K130333) | Terumo Cardiovascular Systems Corp. | 2013-03-13 |
| CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR (K130280) | Terumo Corporation | 2013-03-13 |
| CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR (K130493) | Terumo Corporation | 2013-03-13 |
| CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA (K130359) | Terumo Cardiovascular Systems Corp. | 2013-03-13 |
| CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR (K130520) | Ashitaka Factory of Terumo Corp. | 2013-03-13 |
| NUVON VITALS CHARTING SYSTEM (K130234) | Nuvon, Inc. | 2013-03-13 |
| HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST (K130153) | Philips Medical Systems | 2013-03-12 |
| DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM03 SERIES MODEL MD03X0 (K123073) | Grandway Technology (Shenzhen) Limited | 2013-03-11 |
| CS-MAG II (K121825) | Biomagnetik-Park GmbH | 2013-03-11 |
| INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B) (K123228) | Biospace Corporation Limited | 2013-03-08 |
| SYNOVIS COLLAGEN MATRIX (TBD) (K122306) | Synovis Surgical Innovations | 2013-03-08 |
| ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ (K122469) | Asahi Intecc Co., Ltd. | 2013-03-08 |
| ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 3300CM ASAHI PTCA GUIDE WIRE ASAHI SIO (K122468) | Asahi Intecc Co., Ltd. | 2013-03-08 |
| SAM JUNCTIONAL TOURNIQUET (K123694) | Sam Medical Products | 2013-03-07 |
| HERO GRAFT (K124039) | Hemoshpere, Inc., A Cryolife Company | 2013-03-07 |
| SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE GUIDEWIRE, X-PEDION HYDROPHILIC GUIDEWIRE, MIRAGE HY (K124007) | Micro Therapeutics, Inc. D/B/A: Ev3, Inc. | 2013-03-07 |
| PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER (K123837) | Biosense Webster, Inc. | 2013-03-05 |
| CIMVA UNIVERSAL (K123472) | Therapeutic Monitoring Systems (Tms), Inc. | 2013-03-05 |
| ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE (K130307) | Celonova Biosciences, Inc. | 2013-03-04 |
| URSA ANGIOGRAPHIC CATHETER (K123818) | Curative Medical Technology, Inc. | 2013-03-04 |
| RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE (K122590) | Terumo Medical Corporation | 2013-03-01 |
| TRANSTEK BLOOD PRESSURE MONITOR (K123780) | Zhongshan Transtek Electronics Co., Ltd. | 2013-03-01 |
| MUSE CARDIOLOGY INFORMATION SYSTEM (K130155) | Ge Medical Systems Information Technologies, Inc. | 2013-03-01 |
| CIRCUFLOW 5150 (K123959) | Devon Medical, Inc. | 2013-02-28 |
| ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE (K123707) | Cook, Inc. | 2013-02-28 |
| DIGITAL ELECTROCARDIOGRAPHS (K123816) | Shenzhen Biocare Electronics Co., Ltd. | 2013-02-27 |
| VITAL SYNC SYSTEM (K123002) | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2013-02-27 |
| VPULSE (K122640) | Cothera, LLC | 2013-02-22 |
| MRI PATIENT MONITORING SYSTEM (MODEL 865214) (K124061) | Invivo Corporation | 2013-02-22 |
| RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULA (K123187) | Edwards Lifesciences, LLC | 2013-02-22 |
| PERCUTANEOUS INTRODUCER KIT (K123974) | Teleflex, Inc. | 2013-02-21 |
| MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM (K124060) | Medicalgorithmics S.A. | 2013-02-21 |
| DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES (K120675) | Grandway Technology (Shenzhen) Limited | 2013-02-14 |
| ECG CHECK (K122184) | Cardiac Designs, LLC | 2013-02-14 |
| CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICE (K123647) | Devon Medical, Inc. | 2013-02-14 |
| DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM15 SERIES (K120673) | Grandway Technology (Shenzhen) Limited | 2013-02-14 |
| EQUAFLOW MULTIVALVE INFUSION CATHETER (K123235) | Cook Incorporated | 2013-02-14 |
| RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER (K123544) | Ev3, Inc. | 2013-02-12 |
| INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED (K130209) | Sorin Group Italia S.R.L. | 2013-02-12 |
| COMPACT DIGITAL BLOOD PRESSURE MONITOR (K122810) | Thermor , Ltd. | 2013-02-08 |
| PULSTAR LOGIX INTERMITTENT PNEUMATIC COMPRESSION SYSTEM (K123308) | Albahealth, LLC | 2013-02-08 |
| AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE AN (K123216) | Aimago SA | 2013-02-07 |
| BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208 (K122587) | St Jude Medical | 2013-02-07 |
| LIFESPAN EPTFE VASCULAR GRAFT (K130016) | LeMaitre Vascular, Inc. | 2013-02-05 |
| CARDEASCREEN (K123217) | Cardea Associates, Inc. | 2013-02-05 |
| WRIST PULSE OXIMETER (K122046) | Beijing Choice Electronic Technololgy Co., Ltd. | 2013-02-04 |
| ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B (K123033) | Rocket Medical Plc | 2013-02-01 |
| V8 TRANSLUMINAL BAV CATHETER (K123111) | Intervalve, Inc. | 2013-01-31 |
| MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN (K123279) | Abbott Vascular | 2013-01-30 |
| PACIFIC PLUS (K123358) | Medtronic Vascular | 2013-01-29 |
| PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY (K123067) | Abbott Vascular, Inc. | 2013-01-29 |
| HEARTSPAN STEERABLE INTRODUCER KIT (K122431) | Thomas Medical Products, Inc. | 2013-01-29 |
| AXERA 2 ACCESS SYSTEM MODEL AXE200 (K123135) | Arstasis, Inc. | 2013-01-28 |
| 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035 (K123632) | Spectranetics Corp. | 2013-01-25 |
| ESA615 (K121860) | Fluke Biomedical | 2013-01-25 |
| REPROCESSED STEERABLE INTRODUCER (K123334) | Stryker Sustainability Solutions, Inc. | 2013-01-24 |
| SUREFLEX STEERABLE GUIDING SHEATH KIT (K122926) | Baylis Medical Co., Inc. | 2013-01-24 |
| AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE (K123314) | Medtronic, Inc. | 2013-01-22 |
| VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE (K123813) | Vasonova, Inc. | 2013-01-18 |
| CRUX VENA CAVA FILTER SYSTEM (K122585) | Crux Biomedical | 2013-01-17 |
| WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS (K123946) | Cincinnati Sub-Zero Products, Inc. | 2013-01-17 |
| DK-PTCA BALLOON CATHETER (K123264) | Intuit Medical, LLC | 2013-01-16 |
| MERIT HYDROPHILIC GUIDE WIRE (K123609) | Merit Medical Systems, Inc. | 2013-01-16 |
| WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM (K123671) | Sanitas, Inc. | 2013-01-16 |
| VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQS (K122873) | Caremed Supply, Inc. | 2013-01-15 |
| QXMEDICAL ACCESS & SUPPORT CATHETER (K123311) | Qxmedical, LLC | 2013-01-14 |
| ANGIOSCULPT PTA SCORING BALLOON CATHETER (K122685) | Angioscore, Inc. | 2013-01-11 |
| SELECTRA 7F CATHETERS (K123324) | Biotronik, Inc. | 2013-01-11 |
| HD-IVUS ULTRASOUND IMAGING SYSTEM (K122878) | Silicon Vally Medical Instruments, Inc. | 2013-01-11 |
| TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT (K122576) | Stryker Neurovascular | 2013-01-11 |
| PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO (K123048) | Advanced Instrumentations, Inc. | 2013-01-11 |
| WA SERIES: WA100; WA200; WD100; WE100, WF100; WB200 (K123839) | Ningbo Diaier Electronic Co., Ltd. | 2013-01-11 |
| TRANSTEK GLASS BODY FAT ANALYZER (K123781) | Zhongshan Transtek Electronics Co., Ltd. | 2013-01-09 |
| AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE (K122914) | Medtronic, Inc. | 2013-01-09 |
| ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER (K122854) | Arrow International (Subsidiary of Teleflex Inc.) | 2013-01-04 |
| DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES (K113787) | Defibtech, LLC | 2013-01-04 |
| BODY FAT SCALE MODEL SF-371 (K122976) | Shenzhen Belter Health Measurement and Analysis TE | 2013-01-04 |
| JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088 (K123194) | North American Rescue Products, Inc. | 2013-01-03 |
| MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER (K122943) | Moor Instruments, Ltd. | 2013-01-03 |
| RETRACTA DETACHABLE EMBOLIZATION COIL (K123712) | Cook Incorporated | 2013-01-03 |