| SYNTEC ORTHODONTIC MINI SCREW (K090476) | Syntec Scientific Corp. | 2009-06-18 |
| OPEN MAGNETIC RESONANCE IMAGING SYSTEM, MODEL MPF3000-III (K091669) | Xioao Mdt Technology Co, Ltd. | 2009-06-18 |
| FLEXICARE MEDICAL ENDOTRACHEAL TUBES (K091591) | Flexicare Medical, Ltd. | 2009-06-17 |
| COSTORSOL (K091245) | Preservation Solutions, Inc. | 2009-06-17 |
| MAGNUM MP FIXATION DEVICE (K091503) | Arthrocare Corp. | 2009-06-17 |
| MULTILINK IMPLANT (K090704) | Ivoclar Vivadent, Inc. | 2009-06-17 |
| LUCAS 2 (K090422) | Jolife AB | 2009-06-17 |
| STRATAPULSE TS AND STRATAPULSE (K090837) | Advanced Medical Photonics | 2009-06-17 |
| SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS) (K090241) | Synthes (Usa) | 2009-06-17 |
| 4D INTEGRATED TREATMENT CONSOLE (K091132) | Varian Medical Systems | 2009-06-17 |
| AMARIS GINGIVA OPAQUER (K090843) | Voco GmbH | 2009-06-17 |
| COCHLEAR BAHA BP100 (K090720) | Cochlear Bone Anchored Systems AB | 2009-06-17 |
| RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM (K090763) | Mako Surgical Corporation | 2009-06-17 |
| 1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50 (K091466) | Medcomp | 2009-06-17 |
| CVS SILVER BANDAGES, WALGREENS SILVER BANDAGES, XYZ SILVER BANDAGES (K082910) | Aso, LLC | 2009-06-17 |
| DUAL SYRINGE HOLDER (K082110) | Surgin Surgical Instrumentation, Inc. | 2009-06-17 |
| EQUIA (K091106) | GC America, Inc. | 2009-06-17 |
| PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM (K090848) | Premier Brands of America, Inc. | 2009-06-17 |
| TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE (K090180) | Vermed, Inc. | 2009-06-17 |
| RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST (K081150) | Turklab Medical Devices, Inc. | 2009-06-16 |
| EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K082879) | I-See Vision Technology, Inc. | 2009-06-16 |
| PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS (K081720) | Prime Herbs Corporation | 2009-06-16 |
| ACTHYDERM (K083016) | Microlab Americas, Inc. | 2009-06-16 |
| EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS (K082880) | I-See Vision Technology, Inc. | 2009-06-16 |
| CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205 (K090721) | Medtronic | 2009-06-16 |
| ACUMED CLAVICLE SCREW SYSTEM (K083144) | Acumed, LLC | 2009-06-16 |
| REJUVENATE MONOLITHIC SIZE 4 HIP STEM (K091161) | Howmedica Osteonics Corp. | 2009-06-16 |
| EZVIEW (POLYMACON) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR (K082883) | I-See Vision Technology, Inc. | 2009-06-16 |
| STATIC VESSEL ANALYZER (K082196) | Imedos GmbH | 2009-06-16 |
| SUPRA 577.Y LASER (K091581) | Quantel Medical | 2009-06-16 |
| DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES (K081259) | Defibtech, LLC | 2009-06-15 |
| HAMILTON-C2 (K090468) | Hamilton Medical AG | 2009-06-15 |
| NOVABONE DENTAL PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT (K091484) | Novabone Products, LLC | 2009-06-15 |
| CLAVICLE PLATING SYSTEM (K090289) | Orthohelix Surgical Designs, Inc. | 2009-06-15 |
| DIGITAL RADIOGRAPHY CXDI-60C (K091545) | Canon, Inc. | 2009-06-15 |
| GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS (K091103) | Hitachi Medical Systems America, Inc. | 2009-06-15 |
| ONCENTRA SIMULATION 2.3 (K090706) | Nucletron Corporation | 2009-06-15 |
| VEINWAVE, TC3000 (K083352) | Newlands Clinical Trials, Ltd. | 2009-06-12 |
| KLS MARTIN ELECTROSURGICAL INSTRUMENTS (K082505) | Kl Martin L.P. | 2009-06-12 |
| STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE (K090929) | Shanghai Double Dove Industrial Co., Ltd. | 2009-06-12 |
| TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II) (K090961) | Twin Star Medical, Inc. | 2009-06-12 |
| ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER (K091527) | Cook, Inc. | 2009-06-12 |
| PATHOLASE FAMILY OF PINPOINTE AND PINPOINTE FOOTLASER ND: YAG LASERS (K083616) | Patholase, Inc. | 2009-06-12 |
| BLUEPHASE 20I (K091020) | Ivoclar Vivadent, Inc. | 2009-06-12 |
| FLOCONTROL , MODEL 1028 (K090970) | Coaxia, Inc. | 2009-06-12 |
| DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS (K090998) | DePuy Orthopaedics, Inc. | 2009-06-12 |
| LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS (K091181) | Smiths Medical MD, Inc. | 2009-06-12 |
| AIRWAY BALLOON CATHETER INFLATION DEVICE (K090660) | Acclarent, Inc. | 2009-06-12 |
| INFANT SLEEP BEANIE (K082367) | Life Innovations, LLC | 2009-06-12 |
| E-MATRIX GRAFT BONE EXTENDER (K083449) | Pioneer Surgical Technology | 2009-06-12 |
| CUSTOM COMFORT NIGHTGUARD VERSION 2 (K091660) | Den Tek Oral Care, Inc. | 2009-06-12 |
| GOPHER GOLD CATHETER, MODEL 5620 (K091345) | Vascular Solutions, Inc. | 2009-06-12 |
| XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01 (K091432) | Anulex Technologies, Inc. | 2009-06-12 |
| VAKU-8 BLOOD COLLECTION NEEDLES (K090426) | Myco Medical Supplies, Inc. | 2009-06-12 |
| QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000 (K090511) | Maquet Cardiopulmonary, AG | 2009-06-12 |
| FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES (K091490) | Thd Spa | 2009-06-11 |
| PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D (K090671) | Contec Medical System Co., Ltd. | 2009-06-11 |
| PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER (K090767) | Interventional Spine, Inc. | 2009-06-11 |
| BAIXIN INTRAVASCULAR ADMINISTRATION SET (K083687) | Anhui Kangda Medical Products Co., Ltd. | 2009-06-11 |
| MODIFICATION TO AVIE A1C TEST SYSTEM (K091400) | Mec Dynamics Corp | 2009-06-11 |
| DISPOSABLE INFUSION SET (K090012) | Shan Dong Wei Gao Group Medical Polymer Products | 2009-06-11 |
| HABIB ENDOHPB (K083292) | Emcision , Ltd. | 2009-06-10 |
| COOLSKIN (K083008) | Elbio Co., Ltd. | 2009-06-10 |
| MI FLOW (GCUC-450) (K090747) | GC America, Inc. | 2009-06-10 |
| VIPER 2 SYSTEM (K090648) | Depuy Spine, Inc. | 2009-06-10 |
| STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM (K090093) | Stanbio Laboratory | 2009-06-10 |
| THEKEN CORAL SPINAL SYSTEM (K091266) | Theken Spine, LLC | 2009-06-10 |
| HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE (K090680) | Becton, Dickinson & CO | 2009-06-10 |
| CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L (K090821) | Frankenman International Limited | 2009-06-10 |
| SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT SILICONE SOFT TIP SPO2 SENSOR (K083010) | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2009-06-10 |
| COR12+ (K091505) | Viasys Healthcare GmbH | 2009-06-10 |
| TRIOS SYSTEM (K090399) | Viora , Ltd. | 2009-06-10 |
| MICROLIFE DIGITAL ELECTRONIC THERMOMETER, MODEL MT16K1 (K091589) | Microlife Intellectual Property GmbH | 2009-06-10 |
| PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 (K083275) | Max Endoscopy, Inc. | 2009-06-09 |
| THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350 (K091340) | Boston Scientific Corp | 2009-06-09 |
| EPIPHANY INJECTION SYSTEM (K090161) | Staar Surgical Co. | 2009-06-09 |
| MAXMORESPINE SPINAL SYSTEM (K090132) | Hoogland Spine Products, GmbH | 2009-06-09 |
| FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC) (K083716) | Church & Dwight Co., Inc. | 2009-06-08 |
| MODIFICATION TO NORDICICE SOFTWARE (K090546) | Nordicimaginglab AS | 2009-06-08 |
| CAPIOX BUBBLE TRAP WITH X-COATING (K090698) | Terumo Cardiovascular Systems | 2009-06-08 |
| OBI (K083669) | Euroteknika | 2009-06-08 |
| SERAQUEST EBV EA-D IGG TEST (K091260) | Quest Intl., Inc. | 2009-06-08 |
| SMITH & NEPHEW RAIL SYSTEM (K090926) | Smith & Nephew, Inc. | 2009-06-08 |
| NUVASIVE NEURO VISION SYSTEM (K090298) | Nuvasive, Inc. | 2009-06-08 |
| CORTOSS BONE AUGMENTATION MATERIAL (K080108) | Orthovita, Inc. | 2009-06-05 |
| EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR (K090922) | Empi | 2009-06-05 |
| RS- LB LOW BACK CONDUCTIVE GARMENT, MODEL RS-LBM, RS-LBL, RS-FBG FULL BACK CONDUCTIVE GARMENT , MODEL RS-FBG (K090951) | Rs Medical | 2009-06-05 |
| BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS (K090933) | Forestadent Bernhard Forster GmbH | 2009-06-05 |
| MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN (K083195) | Lang Dental Mfg. Co., Inc. | 2009-06-05 |
| PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE (K083415) | Peak Surgical, Inc. | 2009-06-05 |
| BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY (K090971) | Becton, Dickinson & CO | 2009-06-05 |
| STAR 55 MODEL 100 (K090172) | Larsen & Toubro Limited | 2009-06-05 |
| COVIDIEN EXTENDED TIP APPLICATOR (K091315) | Confluent Surgical,Inc | 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 |
| CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3 (K090283) | Genchem, Inc. | 2009-06-05 |
| A6 LUER ACCESS DEVICE (K083723) | B.Braun Medical, Inc. | 2009-06-05 |
| RADIA STEERABLE DIAGNOSTIC CATHETER (K091370) | C.R. Bard, Inc. | 2009-06-05 |
| XPI ANGLED ABUTMENTS (K090397) | Keystone Dental, Inc. | 2009-06-05 |
| PLANET 55, MODEL 100 (K090443) | Larsen & Toubro Limited | 2009-06-05 |