| NMI FC (K091634) | Navilyst Medical, Inc. | 2010-03-01 |
| ASAHI ZENYTEEX GUIDING CATHETER (K091188) | Asahi Intecc Co., Ltd. | 2010-02-26 |
| TELESENTRY, MODEL TS01 (K092947) | Scottcare Corporation | 2010-02-26 |
| TRAILRUNNER GUIDEWIRES (K092965) | Lake Region Mfg., Inc. | 2010-02-26 |
| ITG VASCULAR ACCESS SYSTEM, MODEL 300 (K091006) | Arstasis, Inc. | 2010-02-25 |
| ENSITE VELOCITY SYSTEM V1.3 (K093942) | St Jude Medical | 2010-02-25 |
| FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER (K093026) | Footprint Medical | 2010-02-24 |
| TRAXCESS DOCKING WIRE (K093647) | MicroVention, Inc. | 2010-02-24 |
| 12SL ECG ANALYSIS PROGRAM (K092369) | Ge Medical Systems Information Technologies | 2010-02-24 |
| ELI PC ELECTROCARDIOGRAPH (K093339) | Mortara Instrument, Inc. | 2010-02-19 |
| CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM) (K091029) | Rex Medical | 2010-02-18 |
| THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200 (K092175) | Flowcardia, Inc. | 2010-02-17 |
| BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM (K093650) | Medtronic, Inc. | 2010-02-17 |
| FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL158BT (K093824) | Health & Life Co., Ltd. | 2010-02-16 |
| 3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LON (K093515) | Brivant, Ltd. | 2010-02-16 |
| IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING (K093004) | Merit Medical Systems, Inc. | 2010-02-12 |
| GLIDER PTA BALLOON CATHETER (K094019) | Trireme Medical, Inc. | 2010-02-12 |
| FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE (K093192) | Advanced Vascular Dynamics | 2010-02-12 |
| AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120 (K093476) | Aga Medical Corp. | 2010-02-05 |
| OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER (K091077) | Cordis Corp., A Johnson & Johnson Co. | 2010-02-04 |
| GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H (K092970) | General Meditech, Inc. | 2010-02-02 |
| HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL (K100063) | Ev3, Inc. | 2010-02-02 |
| URSA ANGIOGRAPHIC CATHETER (K090427) | Curative Medical Technology, Inc. | 2010-01-29 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-557 (K100014) | Andon Health Co, Ltd. | 2010-01-29 |
| DOCKING STATION,TEIRSTEIN EDGE,ANGIOASSIST COMBINATION DEVICE, ANGIOASSIST FAMILY (K093822) | Shepherd Scientific, Inc. | 2010-01-28 |
| MERIDIAN GUIDEWIRE (K093681) | Ev3 Neurovascular | 2010-01-26 |
| U-RIGHT TD-3132 BLOOD PRESSURE MONITOR, FORA P 20 BLOOD PRESSURE MONITOR, MODEL TD-3132, TD-3132 (K092106) | Taidoc Technology Corporation | 2010-01-25 |
| TURBO-TANDEM SYSTEM MODEL 472-110 (K094036) | Spectranetics Corp. | 2010-01-25 |
| FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888V, FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868JM (K093823) | Health & Life Co., Ltd. | 2010-01-22 |
| AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS (K093986) | Sorin Group Italia S.R.L. | 2010-01-22 |
| JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE) (K093918) | Pathway Medical Technologies, Inc. | 2010-01-21 |
| FOGARTY OCCLUSION CATHETER (K093911) | Edwards Lifesciences, LLC | 2010-01-21 |
| ODYSSEY WORKSTATION (K093092) | Stereotaxis, Inc. | 2010-01-21 |
| THE PICC WAND PEELABLE SAFETY INTRODUCER (K093022) | Access Scientific, Inc. | 2010-01-20 |
| QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000) (K093172) | Dynacardia, Inc. | 2010-01-20 |
| CEROX MODEL 3210 (K093923) | Or-Nim Medical , Ltd. | 2010-01-19 |
| SORIN C5 SYSTEM MODEL 58-00-00 (K093882) | Sorin Group Deutschland GmbH | 2010-01-15 |
| PICA CATHETER (K093970) | Penumbra, Inc. | 2010-01-15 |
| ADAGIO RETRACTING ECG LEAD WIRES (K093657) | Acist Medical Systems, Inc. | 2010-01-15 |
| TYTAN AUTOMATIC ANEROID SPHYGMOMANOMETER, MODEL A730 AND MANUAL DIGITAL LCD SPHYGMOMANOMETER, MODEL A830 SERIES (K092893) | Tytan Medical Corp. | 2010-01-14 |
| ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER SYSTEM-JUGULAR/SUBCLAVIAN DELIVERY KIT MODEL RF500F MODEL RF5 (K093659) | C.R. Bard, Inc. | 2010-01-14 |
| RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL VASOPRESS FOOT GARMENTS (K093658) | Renu Medical, Inc. | 2010-01-14 |
| REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS (K092158) | Sterilmed, Inc. | 2010-01-14 |
| ALBOGRAFT VASCULAR PROSTHESIS (K093231) | LeMaitre Vascular, Inc. | 2010-01-14 |
| PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24) (K093730) | Edwards Lifesciences, LLC | 2010-01-14 |
| LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES (K093832) | Levitronix, LLC | 2010-01-13 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7035B, KD-7921, KD-7903 (K092811) | Andon Health Co, Ltd. | 2010-01-13 |
| ANGIOGRAPHIC CATHETER, MODEL ANGIOS (K092118) | Oscor, Inc. | 2010-01-13 |
| EVALVE STEERABLE GUIDE CATHETER (K093866) | Evalve, Inc. | 2010-01-13 |
| LIFENET SYSTEM (K093925) | Physio-Control, Inc. | 2010-01-12 |
| FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA (K092652) | Beijing Choice Electronic Technololgy Co., Ltd. | 2010-01-08 |
| MICRO-STICK SET (K091954) | Medcomp | 2010-01-08 |
| BLOOD PRESSURE MONITOR, MODEL MD200A (K093013) | Beijing Choice Electronic Technololgy Co., Ltd. | 2010-01-08 |
| GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS (K093817) | Vascutek, Ltd. | 2010-01-07 |
| CARDIO-WRAP (K090637) | Mast Biosurgery USA, Inc. | 2010-01-07 |
| THERMODILUTION CATHETER (K083384) | Biosensors Intl. Pte. , Ltd. | 2010-01-05 |
| MIKRO-CATH, MODEL 825-0101 (K093111) | Millar Instruments, Inc. | 2010-01-05 |
| ENABLER-P CATHETER SYSTEM, MODEL 3000 (K092174) | Endocross, Ltd. | 2009-12-30 |
| BANTAM,48XXXXXX, 50XXXXXX (K093139) | ClearStream Technologies , Ltd. | 2009-12-30 |
| MARS HOLTER ANALYSIS WORKSTATION (K093141) | Ge Medical Systems Information Technologies | 2009-12-29 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5910,KD-5911, KD-5918 (K092588) | Andon Health Co, Ltd. | 2009-12-29 |
| PARADIS VASO SHIELD (K093551) | Spinemedica, LLC | 2009-12-24 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7901, KD-7905, KD-7911 (K092510) | Andon Health Co, Ltd. | 2009-12-23 |
| ZOLL E SERIES WITH CPRREADYCHARGE (K091265) | Zoll Medical Corporation, World Wide Headquarters | 2009-12-23 |
| VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING (K090690) | Maquet Cardiopulmonary, AG | 2009-12-23 |
| PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30 (K090555) | Maquet Cardiopulmonary, AG | 2009-12-23 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-571, KD-7971 (K093452) | Andon Health Co, Ltd. | 2009-12-23 |
| VENOUS HARDSHELL CARDIOTOMY RESERVIORS (K090534) | Maquet Cardiopulmonary, AG | 2009-12-23 |
| STERLING SL MONORAIL PTA BALLOON DILATATION CATHETERS STERLING SL OVER-THE-WIRE BALLOON DILATATION CATHETERS MODEL VARIO (K093720) | Boston Scientific Corp | 2009-12-23 |
| STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS MODEL H74939334XXXXXXX (K093636) | Boston Scientific Corp | 2009-12-23 |
| QUART ARTERIAL FILTER WITH SOFTLINE COATING (K090518) | Maquet Cardiopulmonary, AG | 2009-12-18 |
| HLM TUBING SET WITH SOFTLINE COATING (K090533) | Maquet Cardiopulmonary, AG | 2009-12-18 |
| INTELLIBRIDGE SYSTEM (K093177) | Philips Medical Systems | 2009-12-18 |
| AF 840 PH.I.S.I.O. ARTERIAL FILTER (K093601) | Sorin Group Italia S.R.L. | 2009-12-18 |
| ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520 (K093050) | Arrow Intl., Inc. | 2009-12-18 |
| ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA) (K090515) | Maquet Cardiopulmonary, AG | 2009-12-18 |
| HEALTHEPOD (K083174) | Card Guard Scientific Survival , Ltd. | 2009-12-17 |
| TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE (K093397) | MicroVention, Inc. | 2009-12-17 |
| MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214 (K090785) | Invivo Corp. | 2009-12-15 |
| EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE (K093583) | St Jude Medical | 2009-12-15 |
| ELI 350 ELECTROCARDIOGRAPH (K092663) | Mortara Instrument, Inc. | 2009-12-14 |
| TERUMO PRESSURE ISOLATOR (K092644) | Terumo Cardiovascular Systems Corp. | 2009-12-10 |
| EAGLE EYE PLATINUM DIGITAL IVUS CATHETER (K092596) | Volcano Corporation | 2009-12-10 |
| HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103 (K092807) | Augustine Biomedical & Design, LLC | 2009-12-10 |
| NEONATAL ECG ELECTRODE, M203KEN (K092744) | R & D Medical Products, Inc. | 2009-12-10 |
| ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA (K093750) | Ev3, Inc. | 2009-12-09 |
| CROSSCATH SUPPORT CATHTER (K093052) | Cook, Inc. | 2009-12-08 |
| QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C (K093522) | Maquet Cardiopulmonary, AG | 2009-12-07 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5963, KD-7963 (K093528) | Andon Health Co, Ltd. | 2009-12-04 |
| GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15 (K091582) | Medtronic Vascular | 2009-12-04 |
| MD300C318 FINGERTIP PULSE OXIMETER (K092620) | Beijing Choice Electronic Technololgy Co., Ltd. | 2009-12-04 |
| SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05 (K091352) | Biosense Webster, Inc. | 2009-12-04 |
| UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES (K092514) | Hangzhou Hua'An Medical & Health Instruments Co., | 2009-12-04 |
| CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES (K093455) | Biosense Webster, Inc. | 2009-12-04 |
| ZOLL E SERIES WITH SPCO/SPMET OPTION (K092598) | Zoll Medical Corporation, World Wide Headquarters | 2009-12-03 |
| H100B PULSE OXIMETER (K092727) | Edan Instruments, Inc. | 2009-12-03 |
| JETSTREAM G3 SYSTEM (K093456) | Pathway Medical Technologies, Inc. | 2009-12-01 |
| 1103 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1103, 1133 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1133 (K093359) | Shanghai Little Doctor Co. Limited | 2009-11-27 |
| CERNER CAREAWARE IBUS (K093134) | Cerner Corp. | 2009-11-27 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5961, KD-5962, KD-5902 (K093387) | Andon Health Co, Ltd. | 2009-11-27 |