| EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION (K081467) | Ekos Corp. | 2008-06-26 |
| CABS'AIR (K072962) | Cousin Biotech Sas | 2008-06-26 |
| AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS (K081612) | Aesculight, LLC | 2008-06-25 |
| SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM (K081395) | Biomet Spine | 2008-06-25 |
| SENTINEL PLASMAPROTEINS CAL 3X (K081533) | SENTINEL CH. SpA | 2008-06-25 |
| CONMED GOLDVAC INTEGRATED SMOKE EVACUATION PENCIL (K081634) | Conmed Corporation | 2008-06-25 |
| LITE WAND II (K080962) | Thompson Surgical Instruments, Inc. | 2008-06-25 |
| DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) (K071603) | Dade Behring, Inc. | 2008-06-25 |
| XTAG RESPIRATORY VIRAL PANEL (K081483) | Luminex Molecular Diagnostics, Inc. | 2008-06-25 |
| ULTIMED ULTICARE SAFETY SYRINGE (K080600) | Ultimed, Inc. | 2008-06-25 |
| QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA (K080381) | Quest Diagnostics, Inc. | 2008-06-25 |
| HEMOCCULT ICT (K080812) | Beckman Coulter, Inc. | 2008-06-25 |
| SYMPHONY GLUCOSE MANAGEMENT SYSTEM (K080639) | Animas Corp. | 2008-06-24 |
| MODIFICATION TO GALILEO GOLD (K080181) | Hamilton Medical AG | 2008-06-24 |
| IPLAN RT IMAGE (K080886) | Brainlab AG | 2008-06-24 |
| MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS (K073556) | Medxpert GmbH | 2008-06-24 |
| DIGITAL RADIOGRAPHY CXDI-60G (K081648) | Canon, Inc. | 2008-06-24 |
| ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM (K080879) | Bioretec, Ltd. | 2008-06-24 |
| CEEMAX SLIT LAMP (HALOGEN LAMP SERIES/SOLID STATE ILLUMINATION SERIES) (K072861) | Acheve Technology, Inc. | 2008-06-24 |
| PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM (K080197) | Plasma Surgical, Ltd. | 2008-06-24 |
| AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES (K081160) | Avita Corporation | 2008-06-24 |
| S-TEST CA (K072356) | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-24 |
| ZURA TEE SYSTEM (K080223) | Imacor, LLC | 2008-06-24 |
| S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU (K072140) | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-24 |
| OSTAPEK VBR SYSTEM (K072326) | Co-Ligne AG | 2008-06-24 |
| VISUAL FOOTCARE TECHNOLOGIES TEMPSTAT (K080816) | Visual Footcare Technologies, LLC | 2008-06-24 |
| HD15 DIAGNOSTIC ULTRASOUND SYSTEM (K081661) | Philips Ultrasound, Inc. | 2008-06-24 |
| S40 CLINICAL ANALYZER, S TEST IP, S TEST UA (K072141) | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-24 |
| ECARD AND CCARD (K081471) | iRhythm Technologies, Inc. | 2008-06-24 |
| INFX-8000F (INFINIX CSI AND INFINIX DPI) (K081624) | Toshiba America Medical Systems, In.C | 2008-06-23 |
| NOMAD PRO X-RAY SYSTEM (K081664) | Aribex, Inc. | 2008-06-23 |
| BIOGRAPH HD FAMILY (K081453) | Siemens Medical Solutions USA, Inc. | 2008-06-23 |
| SHARPS TRANSPORT TUBE, MODEL 50035 (K073577) | Sharps Compliance, Inc. | 2008-06-23 |
| BENEVIEW T SERIES PATIENT MONITORS, MODELS T8, T6 AND T5 (K073280) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008-06-23 |
| NUCLISENS EASYQ ENTEROVIRUS SYSTEM (K063261) | bioMerieux, Inc. | 2008-06-23 |
| INFX-8000C (INFINIX CC-I AND VC-I) (K081621) | Toshiba America Medical Systems, In.C | 2008-06-23 |
| CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243 (K081144) | Taidoc Technology Corporation | 2008-06-23 |
| LAMIN AIR (K080516) | Remgenic, LLC | 2008-06-23 |
| FREEDOM SCIENCES MOTION CONTROL MODULE (MCM) (K073330) | Freedom Sciences, LLC | 2008-06-20 |
| HORIZON XVU (K081484) | Mennen Medical , Ltd. | 2008-06-20 |
| SMARTBURS (K080687) | S.S. White Burs, Inc. | 2008-06-20 |
| DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2 (K072985) | Duckworth & Kent, Ltd. | 2008-06-20 |
| PATIENT CABLE (K080112) | Med-Dyne | 2008-06-20 |
| CERAMENT BONE VOID FILLER, MODEL A0210 (K073316) | Bonesupport AB | 2008-06-20 |
| PALOMAR LUX 1540 HANDPIECE (K080244) | Palomar Medical Products, Inc. | 2008-06-20 |
| MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR (K081428) | Biocomposites, Ltd. | 2008-06-20 |
| PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT (K080675) | PAJUNK GmbH Medizintechnologie | 2008-06-20 |
| MERCURY VCO2 MODULE WITH CAPNOSTAT 5 (K080652) | Respironics Novametrix, LLC | 2008-06-20 |
| DR VISION NEO, DR VISION DOU (K080614) | Almana Medical Imaging | 2008-06-20 |
| ENDOSCOPY VIDEO CAMERA SYSTEM (K081585) | Vision Systems Group, A Division of Viking Systems | 2008-06-20 |
| ACCELA SYSTEM (K081578) | Genesis Biosystems, Inc. | 2008-06-20 |
| PRO TENS, MODEL WL-240 RX (K080304) | Well-Life Healthcare Limited | 2008-06-20 |
| OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 (K081094) | Olympic Medical Corp. | 2008-06-20 |
| MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO (K081628) | New Star Lasers, Inc. | 2008-06-20 |
| EPLEY OMNIAX (K071973) | Vesticon | 2008-06-20 |
| APEXPRO TELEMETRY SYSTEMS (K080251) | Ge Medical Systems Information Technologies | 2008-06-20 |
| MACS CPAP SYSTEM (K080692) | Airon Corporation | 2008-06-20 |
| VELOCITYAIS, VELOCITY AI, VELOCITYVX, VELOCITYRT, V-RESPONSE (K081076) | Velocity Medical Solutions, LLC | 2008-06-20 |
| MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II (K080368) | Mako Surgical Corp. | 2008-06-20 |
| CROSSER LP SYSTEM (K080765) | Flowcardia, Inc. | 2008-06-20 |
| TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET (K080811) | Roche Diagnostics Corp. | 2008-06-20 |
| BEAMER ARGON SNARE PROBE (K081580) | Conmed Corporation | 2008-06-19 |
| DERMA SCIENCES OTC MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY (K081584) | Derma Sciences, Inc. | 2008-06-19 |
| SMITH & NEPHEW CDS SYSTEM (K081491) | Smith & Nephew, Inc. | 2008-06-19 |
| ESTELITE SIGMA QUICK (K080940) | Tokuyama Dental Corporation | 2008-06-19 |
| YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP-600J (K081590) | Ya Horng Electronic Co., Ltd. | 2008-06-19 |
| RELIMESH (K081327) | Herniamesh S.R.L. | 2008-06-19 |
| MULTIGENT CREATININE (ENZYMATIC) ASSAY (K073634) | SENTINEL CH. SpA | 2008-06-19 |
| LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE (K081221) | Levitronix, LLC | 2008-06-19 |
| MICRO-TOUCH NITRAFREE (K080536) | Ansell Healthcare Products, LLC | 2008-06-19 |
| PRONTOSAN WOUND IRRIGATION SOLUTION (K072876) | B.Braun Medical, Inc. | 2008-06-19 |
| WOUNDSTAT (K081183) | Traumacure, Inc. | 2008-06-19 |
| TUTOPATCH, TUTOMESH (K081538) | Rti Biologics, Inc. | 2008-06-19 |
| DUREX SYNTHETIC POLYISOPRENE MALE CONDOM (K072169) | Ssl Americas, Inc. | 2008-06-19 |
| MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL (K081322) | Shanghai Chenguang Medical Technologies Co, Ltd. | 2008-06-18 |
| LUXTEC MLX LIGHT SOURCE (K081477) | Integra Luxtec, Inc. | 2008-06-18 |
| PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201 (K081340) | Shanghai Chenguang Medical Technologies Co, Ltd. | 2008-06-18 |
| COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D (K080580) | Axelgaard Mfg. Co., Ltd. | 2008-06-18 |
| BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPIN (K081392) | Bioretec, Ltd. | 2008-06-18 |
| OCCLUSION BALLOON CATHETER, MODEL VENOS (K081052) | Oscor, Inc. | 2008-06-18 |
| PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM VOLAR DISTAL RADIUS LOCKING PLATE FOR THE UPPER EXTREMITY-ASTM F139 (K081106) | Smith & Nephew, Inc. | 2008-06-18 |
| ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO COIL, MODEL MR-RBC-150N (K081198) | Hitachi Medical Systems America, Inc. | 2008-06-18 |
| VACUETTE PREMIUM SAFETY NEEDLE SYSTEM (K072602) | Medpro Safety Products, Inc. | 2008-06-18 |
| INFX-8000V, INFINIX-CFI AND INFINIX VFI (K081582) | Toshiba America Medical Systems, In.C | 2008-06-17 |
| DC NEURO (K081262) | Invivo Corporation | 2008-06-17 |
| INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL (K081057) | Intact Medical Corporation | 2008-06-17 |
| KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT (K080523) | Kronus Market Development Associates, Inc. | 2008-06-17 |
| CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS (K081324) | Candela Corp. | 2008-06-17 |
| E-POLY TIBIAL BEARINGS (K080528) | Biomet Orthopedics, Inc. | 2008-06-17 |
| VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE (K081439) | Orthovita, Inc. | 2008-06-17 |
| THREE STAGE VENOUS RETURN CANNULA, MODEL 816460 (K080034) | Terumo Cardiovascular Systems Corp. | 2008-06-17 |
| ASCENSION PYROCARBON LUNATE (K080997) | Ascension Orthopedics, Inc. | 2008-06-17 |
| MEDRAD INTEGO PET INFUSION SYSTEM (K080297) | Medrad, Inc. | 2008-06-17 |
| ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) (K072560) | Teikoku Pharma USA, Inc. | 2008-06-17 |
| ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD) (K080615) | Titan Spine, LLC | 2008-06-17 |
| MODIFICATION TO CORAL SPINAL SYSTEM (K081414) | Theken Spine, LLC | 2008-06-17 |
| MODIFICATION TO: SPIRIT (K080023) | Caire, Inc. | 2008-06-16 |
| AXIS FIXATION SYSTEM (K062254) | Medtronic Sofamor Danek, Inc. | 2008-06-16 |
| MRSASELECT - EXTENDED INCUBATION (K081212) | Bio-Rad | 2008-06-13 |
| FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-058 (K080902) | Lorenz Biotech S.P.A. | 2008-06-13 |