| COR12+ (K091505) | Viasys Healthcare GmbH | 2009-06-10 |
| CAPIOX BUBBLE TRAP WITH X-COATING (K090698) | Terumo Cardiovascular Systems | 2009-06-08 |
| STAR 55 MODEL 100 (K090172) | Larsen & Toubro Limited | 2009-06-05 |
| MP5 INTELLIVUE PATIENT MONITOR (K091395) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009-06-05 |
| MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM (K083862) | Medapps, Inc. | 2009-06-05 |
| RADIA STEERABLE DIAGNOSTIC CATHETER (K091370) | C.R. Bard, Inc. | 2009-06-05 |
| PLANET 55, MODEL 100 (K090443) | Larsen & Toubro Limited | 2009-06-05 |
| FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5903, KD-5909 (K090772) | Andon Health Co, Ltd. | 2009-06-04 |
| FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5905 (K090770) | Andon Health Co, Ltd. | 2009-06-04 |
| OPTION VENA CAVA FILTER (K081410) | Rex Medical | 2009-06-04 |
| FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL, KD-5962 (K090771) | Andon Health Co, Ltd. | 2009-06-04 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7961 (K090769) | Andon Health Co, Ltd. | 2009-06-04 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD 5901, KD-7909, (K090768) | Andon Health Co, Ltd. | 2009-06-04 |
| MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S (K090114) | Oscor, Inc. | 2009-06-04 |
| LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL (K083336) | Smiths Medical Asd, Inc. | 2009-06-03 |
| SE-601 SERIES ELECTROCARDIOGRAPH (K090367) | Edan Instruments, Inc. | 2009-06-03 |
| ISOFLOW INFUSION CATHETER (K081147) | Vascular Designs, Inc. | 2009-05-29 |
| THE CROSSER 14 OTW CATHETER, MODEL CRU014 (K091254) | Flowcardia, Inc. | 2009-05-29 |
| PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH (K091329) | Terumo Medical Corp. | 2009-05-29 |
| CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS (K090602) | Cardiodynamics International Corp. | 2009-05-28 |
| ECSCOPE 100 (K091358) | Dyansys, Inc. | 2009-05-28 |
| 506CN PATIENT MONITOR (K091050) | Criticare Systems, Inc. | 2009-05-27 |
| ENABLER-P CATHETER, 1000 PART NUMBER:1160 (K083833) | Endocross, Ltd. | 2009-05-22 |
| MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG (K090037) | Medicalgorithmics SP Z.O.O. | 2009-05-22 |
| ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010 (K083328) | St Jude Medical | 2009-05-22 |
| EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19 (K090665) | Abbott Vascular-Vascular Solutions | 2009-05-22 |
| SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL (K091206) | Transoma Medical | 2009-05-18 |
| EPICARDIA 5000 (K090834) | Medicomp, Inc. | 2009-05-15 |
| MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT (K082403) | Gish Biomedical, Inc. | 2009-05-15 |
| MODIFICATION TO THE CROSSER SYSTEM (K091119) | Flowcardia, Inc. | 2009-05-15 |
| BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER (K081130) | Bridgepoint Medical | 2009-05-14 |
| VITAL SIGNS MONITOR (K083821) | Edan Instruments, Inc. | 2009-05-14 |
| ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM (K081803) | St Jude Medical | 2009-05-13 |
| AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100 (K083214) | Aga Medical Corp. | 2009-05-12 |
| SCALEMAN BODY FAT SCALES, MODEL: FS-148BW1 SERIES (K083838) | Fook Tin Technologies Limited | 2009-05-12 |
| ZIO PATCH, MODEL Z100 (K090363) | iRhythm Technologies, Inc. | 2009-05-08 |
| ACCUTORR V MONITOR, MODEL 0998-00-2000 (K091068) | Datascope Corp., Patient Monitoring Division | 2009-05-08 |
| CIRCULATOR BOOT (K082134) | Circulator Boot Corp. | 2009-05-07 |
| SAFEFLO VENA CAVA FILTER (K081138) | Rmt Medical Technilogies, Inc. | 2009-05-07 |
| HANSEN MEDICAL ARTISAN S CONTROL CATHETER (K090365) | Hansen Medical, Inc. | 2009-05-07 |
| ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC (K090428) | Genesee Biomedical, Inc. | 2009-05-07 |
| HD GUIDE CATHETER (K090335) | Concentric Medical, Inc. | 2009-05-06 |
| MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00 (K083922) | Micrus Endovascular Corporation | 2009-05-06 |
| PHILIPS M3001A MULTI MEASUREMENT SERVER (K090360) | Philips Medizin Systeme Boblingen GmbH | 2009-05-04 |
| CROSS-PILOT TURBO ELITE SUPPORT CATHETER (K090913) | Spectranetics Corp. | 2009-05-04 |
| ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORY (K090870) | Micro Therapeutics, Inc. | 2009-05-01 |
| MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150 (K090849) | Ev3, Inc. | 2009-05-01 |
| RESTEP DVY SYSTEM, MODEL RSP-101 (K090308) | Stortford Medical, LLC | 2009-05-01 |
| BCI WW1030 PULSE OXIMETER (K083557) | Smiths Medical Pm, Inc. | 2009-05-01 |
| SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE (K090556) | Spacelabs Healthcare Medical Equipment (Suzhou) CO | 2009-04-30 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556 (K090963) | Andon Health Co, Ltd. | 2009-04-30 |
| BCI WW1021 PC APPLICATION (K090205) | Smiths Medical Pm, Inc. | 2009-04-28 |
| ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER (K090822) | Cook, Inc. | 2009-04-27 |
| STEERABLE GUIDE CATHETER (K083793) | Evalve, Inc. | 2009-04-27 |
| PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P (K083351) | Comdek Industrial Corp. | 2009-04-24 |
| CLUE MEDICAL AND CLUE MEDICAL BASIC (K083630) | Telovital GmbH Telemedizin | 2009-04-23 |
| YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-700, BP-700T, BP700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB (K090058) | Ya Horng Electronic Co., Ltd. | 2009-04-22 |
| ULTIMUM/ENGAGE/ENGAGE TR (K091137) | St Jude Medical | 2009-04-22 |
| BLOOD MONITORING UNIT, MODEL BMU 40 (K090147) | Maquet Cardiopulmonary, AG | 2009-04-22 |
| HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFS (K090074) | Hygia Health Services, Inc. | 2009-04-22 |
| MECC SET WITH BIOLINE COATING (K083794) | Maquet Cardiopulmonary, AG | 2009-04-21 |
| PARADIS VASO SHIELD (K090022) | Spinemedica, LLC | 2009-04-20 |
| TERUMO PALL AL6X ARTERIAL FILTER (K083834) | Terumo Cardiovascular Systems Corp. | 2009-04-17 |
| IMPELLA 5.0 CATHETER FAMILY (K083111) | Abiomed, Inc. | 2009-04-16 |
| HYPERGLIDE OCCLUSION BALLOON SYSTEM (K090728) | Ev3, Inc. | 2009-04-16 |
| CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100 (K083623) | Edwards Lifesciences, LLC | 2009-04-15 |
| BCI WW1000 PULSE OXIMETER, MODEL WW1000 (K083787) | Smiths Medical Pm, Inc. | 2009-04-15 |
| RTX 3371 (K090886) | Tunstall Healthcare | 2009-04-15 |
| MODIFICATION TO DASH 2500 PATIENT MONITOR (K090702) | Ge Medical Systems Information Technologies | 2009-04-15 |
| BIOCARDIA MORPH SHEATH GUIDE (K090999) | Biocardia, Inc. | 2009-04-15 |
| LIFEBED NETWORK PATIENT VIGILANCE SYSTEM (K083534) | Hoana Medical, Inc. | 2009-04-13 |
| DETLOGIX ANNULOPLASTY RING, MODEL: 5100 (K083191) | Edwards Lifesciences, LLC | 2009-04-10 |
| CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPE (K090014) | Caremate Medical Device Co., Ltd. | 2009-04-09 |
| BCI WW1020 PULSE OXIMETER, MODEL WW1020 (K083705) | Smiths Medical Pm, Inc. | 2009-04-09 |
| ELECTRONIC HOUSE CALL (K090801) | Express MD Solutions, LLC | 2009-04-08 |
| ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001 (K090253) | Possis Medical, Inc. | 2009-04-08 |
| GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER (K090140) | William Cook Europe Aps | 2009-04-03 |
| MODIFICATION TO: MICRO-INDUCTION 1000 SYSTEM (K090249) | Harbinger Medical, Inc. | 2009-04-03 |
| MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN CANNULAE (X-COATING) (K090878) | Terumo Cardiovascular Systems Corp. | 2009-04-03 |
| MD2000A VITAL SIGN MONITOR, MODEL MD2000A (K083466) | Beijing Choice Electronic Technololgy Co., Ltd. | 2009-04-03 |
| APK SPO2 PULSE OXIMETER SENSOR (K082846) | APK Technology Co., Ltd. | 2009-04-03 |
| INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C (K082327) | Somanetics Corp. | 2009-04-03 |
| COOK MREYE EMBOLIZATION COILS (K090624) | Cook, Inc. | 2009-04-02 |
| REPLICATION MEDICAL VESSEL GUARD (K082782) | Replication Medical, Inc. | 2009-04-02 |
| LNCS OXIMETRY SENSORS (K083622) | Masimo Corporation | 2009-04-02 |
| STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 (K090163) | St Jude Medical | 2009-04-01 |
| VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C (K083820) | Vasomedical, Inc. | 2009-04-01 |
| PK-141 PATIENT CABLE (K083674) | Biotronik, Inc. | 2009-04-01 |
| REPROCESSED ELECTROPHYSIOLOGY CATHETERS (K090323) | Ascent Healthcare Solutions | 2009-04-01 |
| PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER, (K083784) | Vascular Solutions, Inc. | 2009-03-30 |
| EPTFE SLFTM SPIRAL VASCULAR GRAFT (K083169) | Tayside Flow Technologies Limited | 2009-03-30 |
| THE WAND MICROACCESS SAFETY INTRODUCER (K090372) | Access Scientific, Inc. | 2009-03-30 |
| ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND GUIDE CATHETERS FOR LEFT HEART DELIVERY (K090659) | Medtronic, Inc. | 2009-03-26 |
| CRITICOOL (K083662) | Mtre Advanced Technology , Ltd. | 2009-03-26 |
| MORTARA STRESS ECHO BED (K082967) | Medical Positioning, Inc. | 2009-03-26 |
| THE MEDCOMP .010 VASCULAR GUIDEWIRES (K081775) | Medcomp | 2009-03-25 |
| REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106 (K090120) | Biosense Webster, Inc. | 2009-03-24 |
| PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE (K090286) | Advanced Vascular Dynamics | 2009-03-23 |
| CAPNOSTAT / CAPNOFLEX CO2 SYSTEM (K083750) | Ge Medical Systems Information Technologies | 2009-03-23 |
| DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT (K082439) | Shandong Weigao Medical Polymer Co., Ltd. | 2009-03-23 |