| NANNOLIGHT INTENSE PULSED LIGHT SYSTEM (K082033) | Global USA Distribution, LLC | 2008-07-31 |
| ABL 80 CO-OX SYSTEM (K080370) | Sendx Medical, Inc. | 2008-07-31 |
| BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM (K081444) | Braemar, Inc. | 2008-07-31 |
| KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K080326) | Andon Health Co, Ltd. | 2008-07-31 |
| MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO (K081870) | GE Healthcare Finland Oy | 2008-07-31 |
| GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLE (K081954) | Gyrus Acmi, Inc. | 2008-07-31 |
| PORCINE SURGICAL MESH; DERMAL MATRIX (K081272) | Brennen Medical, LLC | 2008-07-31 |
| HEMOSIL D-DIMER (K073042) | Instrumentation Laboratory | 2008-07-31 |
| CYTO-CHEX BCT (K080552) | Streck | 2008-07-31 |
| MDF REVISION HIP SYSTEM (K081124) | Smith & Nephew, Inc. | 2008-07-31 |
| FABIUS MRI (K072884) | Draeger Medical AG & Co. KG | 2008-07-30 |
| JOINT STIM, MODEL 1000 (K073386) | Pain Management Technologies | 2008-07-30 |
| CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM (K081836) | Carestream Health, Inc. | 2008-07-30 |
| MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) (K081698) | Image Stream Medical, Inc. | 2008-07-30 |
| MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM (K080995) | Affymetrix, Inc. | 2008-07-30 |
| SPSMEDICAL SPORVIEW PA CULTURE SET (K081879) | Spsmedical Supply Corp. | 2008-07-30 |
| THD SLIDE (K081429) | Thd Spa | 2008-07-30 |
| PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST (K080896) | Pathwork Diagnostics, Inc. | 2008-07-30 |
| STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER (K080832) | Sorin Group Deutschland GmbH | 2008-07-30 |
| STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (K081466) | Smart Glove Corp. Sdn Bhd | 2008-07-30 |
| G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS (K080668) | C.R. Bard, Inc. | 2008-07-30 |
| GENADYNE A4 POWERED SUCTION PUMP (K080745) | Genadyne Biotechnologies, Inc. | 2008-07-30 |
| ANCHORAGE SCOPE, MODEL 000003 (K080780) | Epitek, Inc. | 2008-07-30 |
| COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS (K081113) | Cook, Inc. | 2008-07-30 |
| LTC VAD SYSTEM, MODELS #VAD.400 (ELECTROSURGICAL GENERATOR); PCS-900 AND PCC-900 (HAND PIECE INSTRUMENTS) (K071759) | Live Tissue Connect, Inc. | 2008-07-30 |
| LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS (K081244) | Biomet Trauma | 2008-07-30 |
| MAESTRO WRIST FRACTURE IMPLANT (K080426) | Biomet Manufacturing Corp | 2008-07-29 |
| LIFEPAK 20E (K073089) | Physio-Control, Inc. | 2008-07-29 |
| REPROCESSED MASIMO PULSE OXIMETER SENSORS (K081238) | Ascent Healthcare Solutions | 2008-07-29 |
| MAMMO WORKSTATION (K081630) | Image Diagnost International GmbH | 2008-07-29 |
| K450 POWERED WHEELCHAIR (K081964) | Permobil AB | 2008-07-29 |
| ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS (K081294) | Siemens Healthcare Diagnostics, Inc. | 2008-07-29 |
| SURGICAL HANDPIECES, MIKRO SAW HANDPIECES (K080939) | W&H Dentalwerk Buermoos GmbH | 2008-07-29 |
| CONMED BEAMER SYSTEM C600 (K081678) | Kls Martin GmbH + Co. KG | 2008-07-29 |
| RSVP PHANTOM PELVIS, MODEL TLP260 (K081760) | The Phantom Laboratory, Inc. | 2008-07-29 |
| FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM (K081112) | Isodose Control B.V. | 2008-07-29 |
| SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L (K081524) | Spectra Medical Devices, Inc. | 2008-07-29 |
| CLEARFIL SA CEMENT (K081583) | Kuraray Medical, Inc. | 2008-07-28 |
| STRYKER SPINE AVS PL PEEK SPACERS (K082014) | Stryker Corp. | 2008-07-28 |
| HOMELOX (K081206) | Respironics, Inc. | 2008-07-28 |
| ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB (K080092) | Roche Diagnostics Corp. | 2008-07-28 |
| IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION (K081976) | Agfa Healthcare Corporation | 2008-07-28 |
| PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE (K080220) | Italia Medica S.R.L. | 2008-07-28 |
| VALVULOTOME BY KOVEN (K080178) | Koven Technology, Inc. | 2008-07-28 |
| ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING (K081430) | Elekta Neuromag OY | 2008-07-28 |
| PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G (K073382) | Focus Diagnostics, Inc. | 2008-07-28 |
| T-STAT 303 ISCHEMIA MONITORING SYSTEM (K081233) | Spectros Corporation | 2008-07-28 |
| OSFERION D (K081561) | Olympus Terumo Biomaterials Corporation | 2008-07-28 |
| ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSAL (K081129) | Surgrx, Inc. | 2008-07-28 |
| DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST (K081161) | Dade Behring, Inc. | 2008-07-28 |
| FLOCHANNEL (K081176) | Chad Therapeutics, Inc. | 2008-07-28 |
| OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503) (K081497) | Arthrocare Corp. | 2008-07-28 |
| EXPRESS CHEST DRAIN (K081718) | Atrium Medical Corp. | 2008-07-25 |
| HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS (K081506) | Hyperbaric America, LLC | 2008-07-25 |
| AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS (K081963) | Agfa Healthcare Corporation | 2008-07-25 |
| INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30V (K081826) | Power Medical Interventions, Inc. | 2008-07-25 |
| EPICOR ABLATION SYSTEM (K080292) | St Jude Medical | 2008-07-25 |
| HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510 (K080969) | Medi Nuclear Corp., Inc. | 2008-07-25 |
| MICROSHEATH LP AND LP-AT (K080849) | Flowcardia, Inc. | 2008-07-25 |
| RELIEVE LAMINOPLASTY FIXATION SYSTEM (K080664) | Globus Medical, Inc. | 2008-07-25 |
| LIASYS WITH MODELS LIASYS (K080468) | Ams S.R.L. Analyzer Medical System | 2008-07-25 |
| SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR (K080922) | Salter Labs, Division of Regulatory Affairs | 2008-07-25 |
| ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR (K080848) | Q3 Innovations, LLC | 2008-07-25 |
| GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK (K081403) | Bionostics, Inc. | 2008-07-25 |
| FORA TD-3224 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM (K081714) | Taidoc Technology Corporation | 2008-07-25 |
| SOLARIS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES (K073249) | Solaris Medical Technology, Inc. | 2008-07-25 |
| SURGICRAFT SURGICAL MESH SYSTEM (K072370) | Surgicraft , Ltd. | 2008-07-24 |
| VOCO PROFLUORID VARNISH (K080814) | Voco GmbH | 2008-07-24 |
| ACTITRAINER (K080545) | Actigraph, LLC | 2008-07-24 |
| ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML (K081325) | Ab Biodisk | 2008-07-24 |
| MEG LAPAROSCOPIC ELECTRODES (K081431) | Bovie Medical | 2008-07-24 |
| MEDELA INVIA WOUND THERAPY (K080357) | Medela AG | 2008-07-24 |
| MODIFICATION TO SINGLE PLANAR MULTI AXIS (SPMA) PEDICLE SCREW SYSTEM (K081790) | Trinity Orthopedics, LLC | 2008-07-24 |
| MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT (K081351) | Smith & Nephew, Inc. | 2008-07-24 |
| ZENIEVA (K073246) | Gorbec Pharmaceutical Services, Inc. | 2008-07-23 |
| SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES (K081353) | Synthes (Usa) | 2008-07-23 |
| POWER ASPIRATOR, MODEL LS2 OR LS2DP (K081593) | Medical Device Resource Corp. | 2008-07-23 |
| NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS (K063841) | Liposcience | 2008-07-23 |
| COSMIC SYSTEM (K080841) | Ulrich GmbH & Co. KG | 2008-07-23 |
| LEGION HINGE KNEE SYSTEM (K081111) | Smith & Nephew, Inc. | 2008-07-23 |
| MEDELA THOPAZ, MODEL 200 0288 (K080212) | Medela AG | 2008-07-23 |
| ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES (K080463) | Alma Lasers , Ltd. | 2008-07-23 |
| INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM (K081070) | Interlace Medical, Inc. | 2008-07-23 |
| TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5 (K073159) | Trauson (Jiangsu) Medical Instrument Co., Ltd. | 2008-07-23 |
| FIXXSURE CROSS LINK (K081331) | Spineworks, LLC | 2008-07-23 |
| REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT (K080512) | Metro Optics of Austin, Inc. | 2008-07-23 |
| FAS-CLEAN ELECTROSURGICAL COATED ACTIVE BLADE (K073616) | Electromedics Co. , Ltd. | 2008-07-23 |
| BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM (K081177) | Blackstone Medical, Inc. | 2008-07-23 |
| ACCUFRAME (K081157) | Cagenix, Inc. | 2008-07-22 |
| BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818 (K081323) | B-K Medical Aps | 2008-07-22 |
| CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM (K081776) | Omega Critical Care Limited | 2008-07-22 |
| ORTHOPEDIATRICS PEDIPLATES SYSTEM (K081407) | OrthoPediatrics Corp. | 2008-07-22 |
| PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040 (K073057) | Peak Surgical, Inc. | 2008-07-22 |
| GE SIGNA MR ONCOLOGY PACKAGE (K081916) | Ge Medical Systems, LLC | 2008-07-22 |
| TRITANIUM ACETABULAR SHELL SYSTEM (K081171) | Howmedica Osteonics Corp. | 2008-07-22 |
| SAVI APPLICATOR KIT (K081677) | Cianna Medical, Inc. | 2008-07-22 |
| GORE VIABIL BILILARY ENDOPROSTHESIS (K081184) | W.L. Gore & Associates, Inc. Medical Products Div. | 2008-07-22 |
| PLEXUR M (K081227) | Osteotech, Inc. | 2008-07-22 |
| ENDODRAPE(TM) (K080341) | Vortek Surgical, LLC | 2008-07-21 |
| DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM (K081249) | Dade Behring, Inc. | 2008-07-21 |