| DENSICHEK PLUS (K083536) | bioMerieux, Inc. | 2009-09-11 |
| TRU FLU, MODEL 751230 (K092553) | Meridian Bioscience, Inc. | 2009-09-11 |
| ZIMMER CONTINUUM ACETABULAR SYSTEM, ZIMMER TRILOGY IT ACETABULAR SYSTEM (K091508) | Zimmer, Inc. | 2009-09-11 |
| HEARTRAIL III GUIDING CATHETER (K092372) | Terumo Corp. | 2009-09-11 |
| SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.1 (K092497) | Smith & Nephew, Inc. | 2009-09-11 |
| VALLEYLAB SUCTION COAGULATOR, MODEL E3305 (K091223) | Covidien LP | 2009-09-11 |
| CABLE READY CABLE GRIP SYSTEM CABLE BUTTON (K091799) | Zimmer, Inc. | 2009-09-11 |
| UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1 (K083679) | Uroval | 2009-09-11 |
| URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS (K082811) | Urit Medical Electronic Co., Ltd. | 2009-09-11 |
| ALCATEL-LUCENT TELEHEATH MANAGER (K092635) | Alcatel-Lucent Canada, Inc. | 2009-09-10 |
| SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057 (K091808) | Hansen Medical, Inc. | 2009-09-10 |
| UNITY BETA PLLA SYSTEM (K090175) | Bonutti Research, Inc. | 2009-09-10 |
| COMFORT TWIN NASAL MASK (K091843) | Respironics Inc., Sleep & Home Respiratory Group | 2009-09-10 |
| POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A (K091943) | Cardiac Science Corporation | 2009-09-10 |
| OSTEOMED FOOT PLATING SYSTEM (K091614) | Osteomed LP | 2009-09-10 |
| BISQUE ZIRCONIA BLANKS, MODEL R610191, R610210, R610211, R610205 (K091852) | Refractron Technologies Corp. | 2009-09-10 |
| OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM (K091937) | Obp Corporation | 2009-09-09 |
| LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603 (K090104) | DiaSorin, Inc. | 2009-09-09 |
| NSM-S15 SYSTEM (K092237) | Neusoft Medical Systems Co., Ltd. | 2009-09-09 |
| S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 (K091544) | Alfa Wassermann, Inc. | 2009-09-09 |
| MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM (K092441) | Conformis, Inc. | 2009-09-09 |
| SPINAL FORAMINOSCOPE (K082841) | Blazejewski Medi-Tech GmbH | 2009-09-09 |
| DOCTOR SMILE A-810 AND B-980 LASERS (K091562) | Lambda Scientific Spa | 2009-09-08 |
| ANGLEFIX T LOCKING PLATE, MODELS AF-001 (PLATE), ST-1 (LOCKING SCREW) (K091619) | Anglefix | 2009-09-08 |
| CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP (K091921) | Codman & Shurtleff, Inc. | 2009-09-08 |
| FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3 (K092645) | Fujirebio Diagnostics,Inc. | 2009-09-05 |
| TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODEL DW100,DW200, DW500,DW700,DW703,DW701M.702M (K091415) | Truly Instrument Co., Ltd. | 2009-09-04 |
| INREACH SYSTEM, MODEL AAS00161-02 (K092365) | Superdimension, Ltd. | 2009-09-04 |
| SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT) (K090254) | Convatec, A Division of E.R. Squibb & Sons, LLC | 2009-09-04 |
| 1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES (K092430) | Inviro Medical Devices, Inc. | 2009-09-04 |
| YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B (K083559) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2009-09-04 |
| EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200 (K091991) | Medica Corp. | 2009-09-04 |
| CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12 (K090871) | Bonesupport AB | 2009-09-04 |
| ATLAS SPINE SPACER (K091406) | Atlas Spine, LLC | 2009-09-04 |
| CLEARVIEW ADVANCED STREP A , MODEL 737-430 (K091489) | Binax, Inc. | 2009-09-04 |
| MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM (K092455) | Boston Scientific Corporation | 2009-09-04 |
| EES SINGLE SITE LAPAROSCOPIC SEAL CAP ASSEMBLY W/ACCESSORIES, MODEL SSL3P, EES FIXED- LENGTH ACCESS RETRACTORS (K091211) | Ethicon Endo-Sugery, LLC | 2009-09-04 |
| TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M (K091434) | Truly Instrument Co., Ltd. | 2009-09-04 |
| SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS (K092396) | Spectranetics Corp. | 2009-09-04 |
| NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS (K091652) | Hartalega Sdn Bhd | 2009-09-04 |
| INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES (K092413) | Inviro Medical Devices, Inc. | 2009-09-04 |
| UCP HOME DRUG SCREENING TESTS (K091588) | Ucp Biosciences, Inc. | 2009-09-04 |
| MODIFICATION TO SI JOINT FUSION SYSTEM (K092375) | SI-BONE, Inc. | 2009-09-04 |
| GEM HEART ONE/ONE+ (K092576) | Gem-Med S.L. | 2009-09-04 |
| CLO-SURPLUS P.A.D. (K092552) | Scion Cardio-Vascular, Inc. | 2009-09-04 |
| CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER (K090898) | Biosense Webster, Inc. | 2009-09-04 |
| SPK SEALANT (K091632) | 3M Company | 2009-09-03 |
| KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC 500, KC600 (K091685) | Kimberly-Clark Corp. | 2009-09-03 |
| CYNOSURE SMARTLIPO MULTIWAVELENGTH LASER WITH 1440NM WAVELENGTH (K091537) | Cynosure, Inc. | 2009-09-03 |
| VENUS DIAMOND FLOW (K091635) | Heraeus Kulzer, LLC | 2009-09-03 |
| GSP INSTRUMENT AND GSP NEONATAL HTSH KIT (K090846) | Perkinelmer, Inc. | 2009-09-03 |
| DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER (K083288) | Innova Vision, Inc. | 2009-09-03 |
| STAXX XD SYSTEM (K090315) | Spine Wave, Inc. | 2009-09-03 |
| VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927 (K091861) | Ortho-Clinical Diagnostics, Inc. | 2009-09-03 |
| KAPPA LIGHT CHAINS (K083602) | SENTINEL CH. SpA | 2009-09-03 |
| THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120 (K090760) | Theratest Laboratories, Inc. | 2009-09-03 |
| ICS CHARTR EP 200 (K092373) | Gn Otometrics | 2009-09-03 |
| COMFORT TWIN NASAL MASK (K091066) | Respironics Inc., Sleep & Home Respiratory Group | 2009-09-03 |
| STRONG IMPLANT HANDPIECES (K092412) | Saeshin Precision Co., Ltd. | 2009-09-03 |
| COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 (K082939) | Cook Urological, Inc. | 2009-09-03 |
| ASCEND (K091155) | Neurometrix, Inc. | 2009-09-03 |
| SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A (K091495) | Olympus Medical Systems Corporation | 2009-09-03 |
| JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE) (K092332) | Pathway Medical Technologies, Inc. | 2009-09-03 |
| SPIROPRO (K092324) | Viasys Healthcare GmbH | 2009-09-03 |
| INSUFLOW DEWHEART (K091366) | Lexion Medical, LLC | 2009-09-03 |
| GSO PCT SPINAL SYSTEM (K091359) | Gold Standard Orthopaedics, LLC | 2009-09-02 |
| NEUTRASAL (K091718) | Bartor Pharmacal Co., Inc. | 2009-09-02 |
| IMRX (K091166) | Imris, Inc. | 2009-09-02 |
| CHISON DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED ARRAY PROBE, TRANSVAGINAL (K091877) | Chison Medical Imaging Co., Ltd. | 2009-09-02 |
| BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000 (K091841) | Bridgepoint Medical | 2009-09-02 |
| OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000 (K092470) | Topcon Corp. | 2009-09-02 |
| PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM (K091312) | Medtronic Neurosurgery | 2009-09-02 |
| WIENER LAB. URINE STRIP 10 AND 11 (K083724) | Wiener Laboratorios Saic | 2009-09-02 |
| MERETE COMPRESSION SCREWS (K091798) | Merete Medical GmbH | 2009-09-02 |
| MODIFICATION TO CD HORIZON SPINAL SYSTEM (K091974) | Medtronic Sofamor Danek USA, Inc. | 2009-09-02 |
| BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 (K083744) | Binax, Inc. | 2009-09-01 |
| MC-245, MC-246, MC-247, MC-341, MC-343, MC-344 (K091676) | Omron Healthcare, Inc. | 2009-09-01 |
| VERIFY SCBI 275F 3-10 (K083665) | STERIS Corporation | 2009-09-01 |
| AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 3MM LOCKING INSERTS (K092419) | Howmedica Osteonics Corp. | 2009-09-01 |
| F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY (K083428) | Fiab Spa | 2009-09-01 |
| XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267 (K083846) | Luminex Molecular Diagnostics, Inc. | 2009-09-01 |
| VALVED TEARWAY INTRODUCER (K090394) | Medcomp | 2009-09-01 |
| ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000 (K090156) | Wcm Waste & Compliance Management, Inc. | 2009-09-01 |
| PRIMAEVA MEDICAL RENESIS SYSTEM (K082391) | Primaeva Medical, Inc. | 2009-09-01 |
| SILS CLINCHER, SILS DISSECTOR, SILS GRASPER, SILS L-HOOK, SILS SHEARS (K091869) | Covidien Lp, Formerly Registered AS United States | 2009-09-01 |
| QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH (K090496) | Cardiac Lead Technologies, Inc. | 2009-09-01 |
| LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200 (K092284) | Medical Device Resource Corp. | 2009-09-01 |
| EK/P. AERUGINOSA PNA FISH (K092393) | Advandx, Inc. | 2009-09-01 |
| TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358 (K091142) | Rti Biologics, Inc. | 2009-08-31 |
| GRINDGUARD (K082723) | Grind Guard Technologies, LLC | 2009-08-31 |
| VS-SENSE TEST (K091287) | Common Sense , Ltd. | 2009-08-31 |
| VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS (K091778) | Vascutek, Ltd. | 2009-08-31 |
| VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-2500 (K091733) | Maquet Cardiovascular, LLC | 2009-08-28 |
| SINUS QUICK EB SYSTEM (K090377) | Neobiotech Co., Ltd. | 2009-08-28 |
| QUATTRO PORCELAIN SYSTEM (K091706) | Dentsply International, Inc. | 2009-08-28 |
| PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2 (K092458) | Isoray Medical, Inc. | 2009-08-28 |
| WAVEON WRX BONE FIXATION SYSTEM (K090304) | Sonoma Orthopedic Products, Inc. | 2009-08-28 |
| VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT (K092486) | Vortex Medical, Inc. | 2009-08-28 |
| ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS (K091844) | Arthrex, Inc. | 2009-08-28 |
| CARESCAPE MONITOR B850 (K092027) | Ge Medical Systems Information Technologies | 2009-08-28 |