| STRYKER SPINE NULOCK ANTERIOR CERVICAL PLATING SYSTEM (K083562) | Stryker Corp. | 2009-03-25 |
| COMFORTLITE NASAL MASK (K082558) | Respironics, Inc. | 2009-03-25 |
| WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055 (K083792) | Medshape Solutions | 2009-03-25 |
| SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES (K083606) | Trek Diagnostic Systems, Inc. | 2009-03-24 |
| N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC (K083445) | Siemens Healthcare Diagnostics | 2009-03-24 |
| BETACHEK GLUCOSE TEST (K062187) | National Diagnostic Products | 2009-03-24 |
| BACTRACK SELECT BREATHALYZER, MODEL S80 (K090067) | Khn Solutions, LLC | 2009-03-24 |
| CPI RAD VISION, MODEL VZW2944XX-YY (K083224) | Communications & Power Industries Canada, Inc. | 2009-03-24 |
| EQUIVABONE (K090310) | Etex Corp. | 2009-03-24 |
| WIRELESS PORTABLE DETECTOR FD-W17 (K090625) | Philips Medical Systems North America Co. | 2009-03-24 |
| IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K083853) | Siemens Healthcare Diagnostics | 2009-03-24 |
| REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106 (K090120) | Biosense Webster, Inc. | 2009-03-24 |
| DIGITAL RADIOGRAPHY CXDI-40G COMPACT (K090623) | Canon USA, Inc. | 2009-03-24 |
| DIGITAL RETINAL CAMERA, CR-1 MARK II (K090466) | Canon, Inc. | 2009-03-23 |
| SIMPLER MINI IMPLANT, MODELS SM 5002, SM 5003, SM 5004 (K083886) | Simpler One Stop | 2009-03-23 |
| BIOGRAPH 16 TRUE POINT SYSTEMS (K083852) | Siemens Medical Solutions USA, Inc. | 2009-03-23 |
| HOYA IS INJECTOR SYSTEM (K081346) | Hoya Surgical Optics, Inc. | 2009-03-23 |
| CIRRUS OPEN (K090080) | Mri-Tech Sp. Zo.O. | 2009-03-23 |
| ACE FISCHER EXTERNAL FIXATION SYSTEM (K083789) | DePuy Orthopaedics, Inc. | 2009-03-23 |
| SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2 (K083780) | Audio Technologies S.R.L. | 2009-03-23 |
| PHASEAL PROTECTOR P14, P21, P28 AND P50 (K090634) | Carmel Pharma Ab. | 2009-03-23 |
| PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE (K090286) | Advanced Vascular Dynamics | 2009-03-23 |
| CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR (K082853) | Inspired Technologies, Inc. | 2009-03-23 |
| CAPNOSTAT / CAPNOFLEX CO2 SYSTEM (K083750) | Ge Medical Systems Information Technologies | 2009-03-23 |
| BRIT PACS SYSTEMS (K081168) | Brit Systems, Inc. | 2009-03-23 |
| DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT (K082439) | Shandong Weigao Medical Polymer Co., Ltd. | 2009-03-23 |
| CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090 (K090083) | Unicare Biomedical, Inc. | 2009-03-23 |
| VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901 (K083891) | Maine Standards Co. | 2009-03-23 |
| DEVON ACCUBP CUFF (K090664) | Devon Medical, Inc. | 2009-03-23 |
| MYOSCIENCE CRYO-TOUCH (K083493) | Myoscience, Inc. | 2009-03-20 |
| SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VM SERIES PATIENT MONITORS (K090483) | Philips Medical Systems | 2009-03-20 |
| STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE (K082689) | Spectra Medical Devices, Inc. | 2009-03-20 |
| RES TRAXX ONLINE, MODEL: R14 (K083816) | Resmed, Ltd. | 2009-03-20 |
| FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20, FOXCROSS .035 PTA CATHETER (K090509) | Abbott Vascular-Vascular Solutions | 2009-03-20 |
| DERMATOLOGIC TREATMENT SYSTEM (DTS) G2 (K082819) | Miramar Labs, Inc. | 2009-03-20 |
| AVIE A1C TEST SYSTEM (K081269) | Mec Dynamics Corp | 2009-03-20 |
| LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM (K083843) | DePuy Orthopaedics, Inc. | 2009-03-20 |
| SYNCHRO HP PLATFORM (K082039) | El.En Electronic Engineering Spa | 2009-03-20 |
| STERIS CMAX XLT SURGICAL TABLE (K090136) | STERIS Corporation | 2009-03-20 |
| DIAMONDBACK 360 DBX (K090521) | Cardiovascular Systems, Inc. | 2009-03-20 |
| OSCAR BONE RESECTOR (K083830) | Orthosonics, Ltd. | 2009-03-20 |
| FUSION ADVANTAGE CERVICAL CAGE, FUSION ADVANTAGE LUMBAR CAGE (K083425) | Adaptive Specialty, LLC | 2009-03-20 |
| NUVASIVE HELIX-T ACP SYSTEM (K083341) | Nuvasive, Inc. | 2009-03-20 |
| BODYMETRIX BX2000 (K082147) | Intelametrix, Inc. | 2009-03-20 |
| SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025 (K083802) | Medi-Globe Corporation | 2009-03-20 |
| ALLURE MB CERAMIC BRACKETS (K090454) | Dentsply Interntional | 2009-03-20 |
| MODIFICATION TO: DSS STABILIZATION SYSTEM (K090408) | Paradigm Spine, LLC | 2009-03-20 |
| OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K (K083720) | Bien-Air Surgery SA | 2009-03-20 |
| BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70 (K083801) | Khn Solutions, LLC | 2009-03-19 |
| TAC-TITE (TM) (K090128) | Core Essence Orthopaedics, Inc. | 2009-03-19 |
| GO GO ELITE TRAVELER V THREE WHEEL SCOOTER, MODEL SC40EV (K090524) | Pride Mobility Products Corp. | 2009-03-19 |
| ACTICARE IC AND TSE (K081835) | Bioinduction Limited | 2009-03-19 |
| PICC (CT RATED AND NON-RATED) (K083873) | Pfm Medical, Inc. | 2009-03-19 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K090537) | Tangshan Jiteng Plastic Products Co., Ltd. | 2009-03-19 |
| HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR (K090108) | Hoveround Corp. | 2009-03-19 |
| DEMASQ IMAGING SPFTWARE DEVICE (K090481) | Demasq Limited | 2009-03-19 |
| FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M (K083697) | Fukuda Denshi USA, Inc. | 2009-03-19 |
| APNEALINK PLUS, MODEL: 22328 (K083575) | Resmed Germany, Inc. | 2009-03-19 |
| POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER (K083675) | C.R. Bard, Inc. | 2009-03-19 |
| REMESENSE (K082594) | Remedent NV | 2009-03-19 |
| AFFIRM CO2 AND AFFIRM CO2 HP (K081424) | Cynosure, Inc. | 2009-03-19 |
| EOI SPINAL SYSTEM (K083825) | Expanding Orthopedics, Inc. | 2009-03-19 |
| FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030) (K083892) | Cas Medical Systems, Inc. | 2009-03-19 |
| STAK-CHEX PLUS RETICS (K090137) | Streck | 2009-03-18 |
| ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U (K090547) | C.R. Bard, Inc. | 2009-03-18 |
| C-REACTIVE PROTEIN (LATEX) (K083444) | Roche Diagnostics Corp. | 2009-03-18 |
| OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN (K081615) | Olympus America, Inc. | 2009-03-18 |
| BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685 (K083490) | Biopro, Inc. | 2009-03-18 |
| INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601 (K083433) | Chattanooga Group | 2009-03-18 |
| SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES) (K090272) | Cardinal Health, Inc. | 2009-03-18 |
| SECURIAN TISSUE REINFORCEMENT MATRIX (K083823) | Xylos Corporation | 2009-03-18 |
| TOKUYAMA TISSUECARE (K081554) | Tokuyama Dental Corporation | 2009-03-18 |
| PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR (K083688) | Pulmonetic Systems, Inc. | 2009-03-18 |
| SPINAL INJECTION SYSTEM (K083909) | Laurimed, LLC | 2009-03-18 |
| SMITH & NEPHEW INSTRUMENT TRAYS (K090562) | Smith & Nephew, Inc. | 2009-03-18 |
| SALTO TALARIS TOTAL ANKLE PROSTHESIS (K090076) | Tornier | 2009-03-17 |
| PRONTOSAN ANTIMICROBIAL WOUND GEL (K090141) | B.Braun Medical, Inc. | 2009-03-17 |
| ELITE MPX LASER SYSTEM WITH XPL HANDPIECE (K090235) | Cynosure, Inc. | 2009-03-17 |
| SMOOTHLIPO (K083478) | Eleme Medical, Inc. | 2009-03-17 |
| BOND BONE (K083858) | Augma Biomaterials, Ltd. | 2009-03-17 |
| EASY MOVING PLUS, SM-XXHF-YY (K090322) | Sedecal., Sa. | 2009-03-17 |
| SV DBS BRAIN ARRAY, MODEL 1500SV-SMS64 (K090267) | Midwest Rf, LLC | 2009-03-16 |
| UROCARE (K090552) | Neusoft Medical Systems Co., Ltd. | 2009-03-16 |
| IVENT101 (K081845) | Versamed Medical Systems, Inc. | 2009-03-16 |
| VITEK 2 GRAM NEGATIVE DORIPENEM (K082346) | bioMerieux, Inc. | 2009-03-16 |
| ZEST NASAL MASK (K083832) | Fisher & Paykel Healthcare, Ltd. | 2009-03-16 |
| OLYMPUS AFP - ALPHA-FETOPROTEIN (K081709) | Olympus Life Science Research Europa GmbH (Europa) | 2009-03-16 |
| EUROIMMUN ANTI BP 180-4X ELISA (IGG) (K083615) | Euroimmun Us, Inc. | 2009-03-16 |
| ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN (K083763) | R4 Vascular, Inc. | 2009-03-16 |
| FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH (K090597) | Pascal Co., Inc. | 2009-03-16 |
| VERADIUS, MODEL 718-130 (K090590) | Philips Medical Systems North America Co. | 2009-03-16 |
| IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1 (K081830) | Phadia AB | 2009-03-16 |
| SERIM DISINTEK GTA 2.1%, MODEL: 5164 (K083295) | Serim Research Corp. | 2009-03-16 |
| VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED (VH2O2) STERILIZATION PROCESSES (K090514) | STERIS Corporation | 2009-03-16 |
| LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM (K090095) | Broncus Technologies, Inc. | 2009-03-13 |
| OXYGEN DEMAND VALVE (K082345) | Bpr Medical, Ltd. | 2009-03-13 |
| MAGNUM M FIXATION DEVICE (K090380) | Arthrocare Corp. | 2009-03-13 |
| AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER (K083919) | Invatec Innovative Technologies, S.R.L. | 2009-03-13 |
| BEL-CYPHER, MODEL Y977 (K090020) | Takara-Belmont Co., Ltd. | 2009-03-13 |
| PICASSO LASER SYSTEM (K083142) | Amd Lasers, LLC | 2009-03-13 |