| TERUMO PALL AL6X ARTERIAL FILTER (K083834) | Terumo Cardiovascular Systems Corp. | 2009-04-17 |
| VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM (K090714) | Medtronic Sofamor Danek | 2009-04-17 |
| VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM (K090679) | Vioptix, Inc. | 2009-04-17 |
| MODIFICATION TO: GIRAFFE AND PANDA WARMER (K090697) | Ohmeda Medical | 2009-04-16 |
| IMPELLA 5.0 CATHETER FAMILY (K083111) | Abiomed, Inc. | 2009-04-16 |
| PROGASTRO CD ASSAY (K090239) | Prodesse, Inc. | 2009-04-16 |
| ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090 (K090854) | American Biological Technologies, Inc. | 2009-04-16 |
| PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS (K090631) | PAJUNK GmbH Medizintechnologie | 2009-04-16 |
| AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT (K081922) | Wallac OY | 2009-04-16 |
| RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01 (K083223) | Abbott Diabetes Care, Inc. | 2009-04-16 |
| VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402 (K090475) | Maine Standards Co. | 2009-04-16 |
| ACTHERM INFRARED EAR THERMOMETER, ACT 8000 SERIES; PROBE COVER FOR ACTHERM INFRARED EAR THERMOMETER, MODEL MEDACCU2010 (K090031) | Actherm, Inc. | 2009-04-16 |
| SILVER WOUND PAD (K083659) | Milliken & Co. | 2009-04-16 |
| HYPERGLIDE OCCLUSION BALLOON SYSTEM (K090728) | Ev3, Inc. | 2009-04-16 |
| TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00 (K083799) | Ark Diagnostics, Inc. | 2009-04-16 |
| ENSPIRE DEBRIDER SYSTEM (K090278) | Spine View, Inc. | 2009-04-15 |
| NAVI ROOT (K083901) | S-Denti Co., Ltd. | 2009-04-15 |
| CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100 (K083623) | Edwards Lifesciences, LLC | 2009-04-15 |
| VIDISTAR PACS & DICOM VIEWER SOFTWARE SERVER SOFTWARE SYSTEM, HEART VIEW, STANDALONE VIEWER (K083910) | Vidistar, LLC | 2009-04-15 |
| ORTHO T. CRUZI ELISA TEST SYSTEM (K072732) | Ortho-Clinical Diagnostics, Inc. | 2009-04-15 |
| TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00 (K082091) | Reametrix, Inc. | 2009-04-15 |
| TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER (K082997) | Terumo Medical Corp. | 2009-04-15 |
| VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247 (K090519) | 3M Company | 2009-04-15 |
| MD213MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR MODEL, L218TJ (K090218) | Nec Display Solutions , Ltd. | 2009-04-15 |
| PRE-FILLED CATHETER INFLATION SYRINGE (K090121) | Avail Medical Products, Inc. | 2009-04-15 |
| EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) (K083381) | Euroimmun Us, Inc. | 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 |
| ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI + STRAUMANN BONE (K083871) | Astra Tech, Inc. | 2009-04-15 |
| MODIFICATION TO DASH 2500 PATIENT MONITOR (K090702) | Ge Medical Systems Information Technologies | 2009-04-15 |
| DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-6900 (K090912) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009-04-15 |
| IBA PROTON THERAPY SYSTEM - PROTEUS 235 (K083058) | Ion Beam Applications S.A. | 2009-04-15 |
| NOVABONE POROUS - SYNTHETIC BONE GRAFT SCAFFOLD (K090731) | Novabone Products, LLC | 2009-04-15 |
| BIOCARDIA MORPH SHEATH GUIDE (K090999) | Biocardia, Inc. | 2009-04-15 |
| ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD) (K083714) | Titan Spine, LLC | 2009-04-15 |
| MD213MG 21.3 DIAGNOSTIC IMAGING LCD MONITOR - L218TL (K090215) | Nec Display Solutions , Ltd. | 2009-04-15 |
| CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES (K083216) | Ciba Vision Corporation | 2009-04-14 |
| BONOS INJECT (K090460) | Aap Biomaterials GmbH | 2009-04-14 |
| MINICAP IMMUNOTYPING, MODEL: 2300 (K082388) | Sebia | 2009-04-14 |
| EZLASE (K083595) | Biolase Technology, Inc. | 2009-04-14 |
| ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORM (K083848) | Alma Lasers , Ltd. | 2009-04-14 |
| CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C (K090618) | Cynosure, Inc. | 2009-04-14 |
| ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIAL (K083841) | Dentsply International, Inc. | 2009-04-14 |
| BLUESHINE GOLD SERIES (K090297) | Blueshine Srl | 2009-04-14 |
| P.D SOFTWARE (K083672) | .Decimal, Inc. | 2009-04-13 |
| SWIFT FX (K090244) | Resmed, Ltd. | 2009-04-13 |
| LIFEBED NETWORK PATIENT VIGILANCE SYSTEM (K083534) | Hoana Medical, Inc. | 2009-04-13 |
| PROGUIDE CHRONIC DIALYSIS CATHETER (K090148) | Merit Medical Systems, Inc. | 2009-04-13 |
| HYDROFRAME (HES) (K090357) | MicroVention, Inc. | 2009-04-10 |
| BLOOD TRANSFUSION SET (K083349) | Shan Dong Wei Gao Group Medical Polymer Products | 2009-04-10 |
| CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES (K090186) | Linvatec Corp. | 2009-04-10 |
| VIDAS CA 125 II ASSAY (K080561) | bioMerieux, Inc. | 2009-04-10 |
| ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY (K082759) | Phadia US, Inc. | 2009-04-10 |
| AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS (K083519) | Covidien Lp, Formerly Registered AS United States | 2009-04-10 |
| EXTREME 4X4-X8 POWER WHEELCHAIR (K090350) | Vestil Manufacturing Corp. | 2009-04-10 |
| ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE (K090189) | Icu Medical, Inc. | 2009-04-10 |
| DETLOGIX ANNULOPLASTY RING, MODEL: 5100 (K083191) | Edwards Lifesciences, LLC | 2009-04-10 |
| WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP (K082065) | Well-Life Healthcare Limited | 2009-04-10 |
| I OPEN 0.5T (K090873) | Beijing Wandong Medical Equipment Co., Ltd. | 2009-04-10 |
| AMS SPECTRA CONCEALABLE PENILE PROSTHESIS (K090663) | American Medical Systems, Inc. | 2009-04-09 |
| CAMBRIA (K082309) | Seaspine, Inc. | 2009-04-09 |
| AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9 (K090043) | Apex BioTechnology Corp. | 2009-04-09 |
| EMINENT SPINE INTERBODY FUSION SYSTEM (K090064) | Eminent Spine | 2009-04-09 |
| PAPCONE (K083012) | Otto Bock Pur Life Science GmbH | 2009-04-09 |
| CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPE (K090014) | Caremate Medical Device Co., Ltd. | 2009-04-09 |
| AEROCHAMBER MINI VENTILATION CHAMBER (K090065) | Trudell Medical Intl. | 2009-04-09 |
| BCI WW1020 PULSE OXIMETER, MODEL WW1020 (K083705) | Smiths Medical Pm, Inc. | 2009-04-09 |
| TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE (K083861) | Interacoustics AS | 2009-04-09 |
| QUIKCLOT INTEVENTIONAL, MODEL P/N 182 (K090620) | Z-Medica Corporation | 2009-04-08 |
| SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100 (K082251) | Beckman Coulter, Inc. | 2009-04-08 |
| INCISIVE FAMILY OF INPULSE ND:YAG LASERS (K083215) | Incisive, LLC | 2009-04-08 |
| PIEZOSURGERY MEDICAL (K083284) | Piezosurgery S.R.L. | 2009-04-08 |
| DIGDOP ULTRASOUND SYSTEM (K090465) | The Newman Group, LLC | 2009-04-08 |
| AVC A/H5N1 FLU TEST (K083278) | Arbor Vita Corportation | 2009-04-08 |
| PROWICK (K083007) | Arthrex, Inc. | 2009-04-08 |
| ELECTRONIC HOUSE CALL (K090801) | Express MD Solutions, LLC | 2009-04-08 |
| BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED (K083483) | Brainlab AG | 2009-04-08 |
| IMMERSION HYDROBATH (K082951) | Arjo Hospital Equipment AB | 2009-04-08 |
| ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM (K090057) | Acon Laboratories Co. | 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 |
| LANX SPINAL FIXATION SYSTEM (K083581) | Lanx, Inc. | 2009-04-07 |
| HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5, (K090723) | Zimmer Dental, Inc. | 2009-04-07 |
| VERSAFIT CUP DOUBLE MOBILITY SYSTEM (K083116) | Medacta International S.A. | 2009-04-07 |
| EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG) (K082130) | Euroimmun Us, Inc. | 2009-04-07 |
| PORTABLE OXYGEN UNIT SCA900 (K080243) | San Cheong Co. , Ltd. | 2009-04-07 |
| VERTIGONE BPPV GOGGLE (K082634) | Vertigone, Inc. | 2009-04-07 |
| CREATININE (K083809) | Abbott Laboratories | 2009-04-07 |
| FREEDOM METAL BACKED TIBIAL COMPONENT (K090411) | Maxx Orthopedics, Inc. | 2009-04-07 |
| WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540 (K083627) | Boston Scientific Corporation | 2009-04-07 |
| YIELD TISSUE SAMPLER (K090853) | Broncus Technologies, Inc. | 2009-04-07 |
| MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM (K090087) | Iradimed Corporation | 2009-04-07 |
| MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEM (K090316) | Lanx, Inc. | 2009-04-07 |
| LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X (K082679) | Sintea Biotech, Inc. | 2009-04-07 |
| CARESTREAM DRX-1 SYSTEM (K090318) | Carestream Health, Inc. | 2009-04-06 |
| SPINNING SPIROS, MODEL CH-2000 (K082806) | Icu Medical, Inc. | 2009-04-06 |
| 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 |
| PINNACLE3 SMARTARC (K090808) | Philips Medical Systems, Inc. | 2009-04-03 |
| RIGIDFIX BIOCRYL CROSS PIN KITS (K090669) | Depuy Mitek, A Johnson & Johnson Company | 2009-04-03 |