| CLEARVIEW ENDOSCOPE COVER (K080740) | Invotec International, Inc. | 2008-12-31 |
| RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050 (K080455) | Quantrx Biomedical Corporation | 2008-12-31 |
| ERBE MODEL VIO 300 D WITH ACCESSORIES (K083452) | Erbe USA, Inc. | 2008-12-31 |
| NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025 (K082203) | Ncontact Surgical, Inc. | 2008-12-30 |
| VIROCULT, MODEL MW950 (K082472) | Medical Wire & Equipment Company (Bath), Ltd. | 2008-12-30 |
| NICOLET CORTICAL STIMULATOR (K072964) | Cardinal Health, Inc. | 2008-12-30 |
| BITTAR ZIRCONIA BLOCKS (K082652) | Bittar Zirconia Block, LLC | 2008-12-30 |
| CARESTREAM PACS, MODEL CARESTREAM PACS VII (K083673) | Carestream Health, Inc. | 2008-12-30 |
| NEVONI CLASSIC, MODEL 6600-PO (K082878) | Nsr Comercio E Representacoes Ltda | 2008-12-30 |
| SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES (K083213) | Synthes (Usa) | 2008-12-30 |
| AMSCO EVOLUTION MEDIUM STEAM STERILIZER (K082435) | STERIS Corporation | 2008-12-30 |
| MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL (K083765) | Medegen Medical Manufacturing Services | 2008-12-30 |
| ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DART (K082999) | Arthrex, Inc. | 2008-12-30 |
| MERIT MICROCATHETER (K082613) | Merit Medical Systems, Inc. | 2008-12-30 |
| WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553 (K083355) | Blairex Laboratories, Inc. | 2008-12-29 |
| LAPEX BCS (K081962) | Meridian Co., Ltd. | 2008-12-29 |
| VICOR PD2I ANALYZER, VERSION 2.1 (K082709) | Vicor Technologies, Inc. | 2008-12-29 |
| MORTARA ELI 350 ELECTROCARDIOGRAPH (K082946) | Mortara Instrument, Inc. | 2008-12-29 |
| FRESENIUS STERILE STAY SAFE CAP (K083542) | Fresenius Medical Care North America | 2008-12-29 |
| CORFLO ANTI IV ENTERAL FEEDING TUBE (K083210) | Corpak Medsystems | 2008-12-29 |
| MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS (K082792) | Medacta International S.A. | 2008-12-29 |
| EVITE XL (K083050) | Draeger Medical AG & Co. KG | 2008-12-29 |
| IKOENGELO, VERSION 2 (K083591) | Ikoetech, LLC | 2008-12-29 |
| CLYDESDALE SPINAL SYSTEM (K083026) | Medtronic Sofamor Danek | 2008-12-29 |
| REJUVENATE MONOLITHIC HIP SYSTEM (K082892) | Howmedica Osteonics Corp. | 2008-12-29 |
| STRYKER DISPOSABLE CRANIAL PERFORATOR BIT (K082010) | Stryker Ireland Ltd., Instruments Division | 2008-12-29 |
| MODIFICATION TO:MICROFUSE BONE VOID FILLER (K083232) | Globus Medical, Inc. | 2008-12-24 |
| FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 (K081060) | Core Essence Orthopaedics, LLC | 2008-12-24 |
| BD BACTEC Plus Aerobic/F Culture Vials (K083572) | Becton, Dickinson & CO | 2008-12-24 |
| IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS (K083347) | Fluke Biomedical | 2008-12-24 |
| LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES (K083091) | Biocompatibles UK Limited | 2008-12-24 |
| ENVISION BLOOD GLUCOSE TEST SYSTEM (K082020) | Infopia Co, Ltd. | 2008-12-24 |
| BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY (K083271) | Nihon Kohden America, Inc. | 2008-12-24 |
| CONQUEST PTA BALLOON DILATATION CATHETER (K083657) | C.R. Bard, Inc. | 2008-12-24 |
| TWIN NEUROTRAC-III (K081551) | Astro-Med, Inc. | 2008-12-24 |
| RSVP HALF SPHERE PHANTOM, MODEL DDP010 (K082909) | The Phantom Laboratory, Inc. | 2008-12-23 |
| QUICKIE RHYTHM (K083249) | Sunrise Medical Hhg, Inc. | 2008-12-23 |
| TT1 GENERAL PURPOSE COIL (K083434) | Tursiop Technologies, LLC | 2008-12-23 |
| TORNADO ROTATABEL SNARE AND POLYP CATCHER (K083049) | Horizons Intl. Corp. | 2008-12-23 |
| ENDOSCOPIC CO2 REGULATION UNIT UCR (K081173) | Olympus Medical Systems Corporation | 2008-12-23 |
| D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT (K081928) | Diagnostic Hybrids, Inc. | 2008-12-23 |
| HELIODENT PLUS (K083344) | Sirona Dental Systems GmbH | 2008-12-23 |
| IMAGE-ARENA APPLICATIONS (K083348) | Tomtec Imaging Systems GmbH | 2008-12-23 |
| BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES (K081971) | Nitritex (M) Sdn. Bhd. | 2008-12-23 |
| QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY (K083613) | Quanta System Spa | 2008-12-23 |
| MISER CONTRAST MANAGEMENT SYSTEM (K083576) | Merit Medical Systems, Inc. | 2008-12-23 |
| SUBCUTANEOUS NEEDLE INFUSION SET (K082818) | Marcal Medical, Inc. | 2008-12-23 |
| COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES (K081768) | Cook Incorporated | 2008-12-23 |
| AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE (K082677) | American Medical Systems, Inc. | 2008-12-23 |
| VIDAS RUB IGG (K080766) | bioMerieux, Inc. | 2008-12-23 |
| D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT (K081746) | Diagnostic Hybrids, Inc. | 2008-12-23 |
| FIXATION TROCARS (K083638) | Applied Medical Resources Corp. | 2008-12-23 |
| ZIMMER ANGLED CONTOUR ZIRCONIA ABUTMENT (K083474) | Zimmer Dental, Inc. | 2008-12-23 |
| ENDOSSEOUS DENTAL IMPLANT SYSTEM (K082651) | Southern Implants, Inc. | 2008-12-22 |
| ABT GLUCOSE CONTROL SOLUTION (K083549) | American Biological Technologies, Inc. | 2008-12-22 |
| NOVEON MODEL LS1100-03 (K083476) | Nomir Medical Technologies, Inc. | 2008-12-22 |
| PHANTOM PLUS CAGE SYSTEM (K082801) | Us Spine | 2008-12-22 |
| ZUMA, MODEL 55-XXXX/56-XXXX (K082926) | Seaspine, Inc. | 2008-12-22 |
| EZLASE (K082938) | Biolase Technology, Inc. | 2008-12-22 |
| AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS) (K082829) | Carleton Life Support Systems, Inc. | 2008-12-22 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM (K083173) | Ortho-Clinical Diagnostics | 2008-12-22 |
| SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER (K081148) | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2008-12-22 |
| CRANIAL PERFORATOR (K082637) | The Anspach Effort, Inc. | 2008-12-22 |
| ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01 (K082953) | Biokit, S.A. | 2008-12-22 |
| BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS (K081008) | Lin-Zhi International, Inc. | 2008-12-22 |
| SMOOTHCOOL HR SYSTEM (K082911) | Jeisys Medical, Inc. | 2008-12-19 |
| PRISMAFLO II (K082758) | Stihler Electronic GmbH | 2008-12-19 |
| UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM (K081930) | Beckman Coulter, Inc. | 2008-12-19 |
| 3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATE (K082643) | Depuy Mitek, A Johnson & Johnson Company | 2008-12-19 |
| CT BRAIN PERFUSION FOR ZIOSTATION (K083084) | Ziosoft, Inc. | 2008-12-19 |
| IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS) (K081855) | Canada, Inc. | 2008-12-19 |
| VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES (K082630) | Zefon Intl. | 2008-12-19 |
| HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED (K082859) | Instrumentation Laboratory CO | 2008-12-19 |
| STRYKER LED LIGHTSOURCE (K082813) | Stryker Corp. | 2008-12-19 |
| HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS (K081827) | The Binding Site, Ltd. | 2008-12-19 |
| AMEDICA DRUG SCREEN TEST CUP (K082898) | Amedica Biotech, Inc. | 2008-12-19 |
| ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM (K083254) | Aloka Co., Ltd. | 2008-12-19 |
| KEY RING ALCOHOL BREATHALYZER (K082086) | The Ashley Collection, Inc. | 2008-12-19 |
| RIMCLOSE BONE ANCHOR (K082729) | Anulex Technologies, Inc. | 2008-12-19 |
| SURGISEAL TOPICAL SKIN ADHESIVE (K082993) | Adhezion Biomedical | 2008-12-19 |
| ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00 (K082114) | Apollo Endosurgery, Inc. | 2008-12-19 |
| BD GENEOHM CDIFF ASSAY (K081920) | Bd Diagnostics (Geneohm Sciences, Inc.) | 2008-12-19 |
| E.COLI/P. AERUGINOSA PNA FISH (K081309) | Advandx, Inc. | 2008-12-19 |
| ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS (K082639) | Zimmer Dental, Inc. | 2008-12-19 |
| INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM, MODEL IS2000, WITH DA VINCI CONNECT AND ONSITE (K081207) | Intuitive Surgical, Inc. | 2008-12-19 |
| ADIN DENTAL IMPLANTS SYSTEM (K081751) | Adin Dental Implants System, Ltd. | 2008-12-19 |
| CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS (K081083) | Thermo Fisher Scientific | 2008-12-19 |
| DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL (K082503) | Siemens Healthcare Diagnostics | 2008-12-19 |
| PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS) (K081608) | Toby Orthopaedics, LLC | 2008-12-19 |
| REGEN COLLAGEN SCAFFOLD (CS) (K082079) | Regen Biologics, Inc. | 2008-12-18 |
| HEATER BASE, MODEL PMH7000 (K080149) | Pacific Medico Co., Ltd. | 2008-12-18 |
| GENADYNE A4 WOUND VACUUM SYSTEM (K082676) | Genadyne Biotechnologies, Inc. | 2008-12-18 |
| BIOFLEX LD-R100 TREATMENT HEAD (K081355) | Meditech International, Inc. | 2008-12-18 |
| X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS (K083301) | Terumo Cardiovascular Systems Corp. | 2008-12-18 |
| INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS (K083527) | Power Medical Interventions, Inc. | 2008-12-18 |
| URONIRS, MODEL 2000 (K082701) | Urodynamix Technologies, Ltd. | 2008-12-18 |
| ASTOFLO PLUS (K082765) | Stihler Electronic GmbH | 2008-12-18 |
| ALPHA ORTHOPAEDICS AT2 SYSTEM (K082956) | Alpha Orthopaedics | 2008-12-18 |
| COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM (K083413) | Philips Medical Systems | 2008-12-18 |
| XENON-100 SCB LIGHT SOURCE, MODEL 20132620 (K082925) | KARL STORZ Endoscopy-America, Inc. | 2008-12-18 |