| RENASYS EZ (K082426) | Smith & Nephew, Inc. | 2008-09-05 |
| SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM (K081016) | Smith & Nephew, Inc. | 2008-09-05 |
| POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330 (K080332) | Boston Scientific Corporation | 2008-09-05 |
| METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER (K081913) | Meta Biomed Co., Ltd. | 2008-09-05 |
| XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC) (K081277) | Medtronic Xomed, Inc. | 2008-09-05 |
| ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK (K081518) | Pentax Medical Company | 2008-09-05 |
| OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181 (K080435) | Olympus Life Science Research Europa GmbH (Europa) | 2008-09-05 |
| TBD ETHICON MESH (K082216) | ETHICON, Inc. | 2008-09-05 |
| BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED (K073615) | Brainlab AG | 2008-09-05 |
| AMICAS PACS, VERSION 6.0 (K082144) | Amicas, Inc. | 2008-09-05 |
| ARDS DENTAL IMPLANTS (K071803) | Ards, Ltd. | 2008-09-05 |
| 3M UNITEK LAVA CHAIRSIDE ORAL SCANNER (K081961) | Brontes Technologies | 2008-09-05 |
| RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06 (K081455) | Rayner Surgical, Inc. | 2008-09-05 |
| CARBOXYLATE CEM, PHOSPHATE CEM (K081702) | S & C Polymer GmbH | 2008-09-05 |
| CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM (K081225) | Cardica, Inc. | 2008-09-05 |
| PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS (K080960) | Abbott Diabetes Care, Inc. | 2008-09-05 |
| MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM (K081747) | Synthes (Usa) | 2008-09-05 |
| FORTOSS VITAL (K082383) | Biocomposites, Ltd. | 2008-09-05 |
| 5MP GRAYSCALE FLAT PANEL DISPLAY, MODEL, 6GF6201-5C$2# (WHERE $ = A-Z AND # = 0-9) (K081357) | Eizo GmbH | 2008-09-05 |
| Z3D CONTRAST ACUITY (K080196) | Clario Medical Imaging, Inc. | 2008-09-05 |
| SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS (K080089) | Sybron Dental Specialties, Inc. | 2008-09-04 |
| NUTRITONE FACIAL BEAUTY SYSTEM (K070250) | Isomers Laboratories, Inc. | 2008-09-04 |
| BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES (K082206) | Helix Medical, LLC | 2008-09-04 |
| ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED) (K080412) | Shanghai Pudong Jinhuan Medical Products Co., Ltd. | 2008-09-04 |
| BLACKSTONE PILLAR XL PEEK SPACERS (K082235) | Blackstone Medical, Inc. | 2008-09-04 |
| MICARDIA ANNULOPLASTY BAND DR (K070488) | Micardia Corporation | 2008-09-04 |
| VEO MULTIGAS MONITOR FOR POCKET PC (K081601) | Phasein AB | 2008-09-04 |
| AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM (K080992) | Aesculap Implant Systems, Inc. | 2008-09-04 |
| RE-ZORB PLATING SYSTEM (K081588) | Acute Innovations, LLC | 2008-09-03 |
| MS SYSTEM (NARROW RIDGE) (K080594) | Osstem Implant Co., Ltd. | 2008-09-03 |
| OLYMPUS TOTAL BHCG TEST SYSTEN (K080094) | Olympus Life Science Research Europa GmbH (Europa) | 2008-09-03 |
| SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS (K073478) | Sybron Dental Specialties, Inc. | 2008-09-03 |
| EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED (K080473) | Medicult A/S | 2008-09-03 |
| GONGDONG DISPOSABLE SHARP CONTAINER (K082042) | Zhejiang Gongdong Medical Plastic Factory | 2008-09-03 |
| MODIFICATIONS TO EXPEDIUM SPINE SYSTEM (K082195) | Depuy Spine, Inc. | 2008-09-03 |
| NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) (K081907) | Siam Sempermed Corp., Ltd. | 2008-09-03 |
| ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN (K080795) | Kimberly-Clark Corp. | 2008-09-03 |
| HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015 (K081758) | Depuy Spine, Inc. | 2008-09-03 |
| STARLIGHT, MODEL PD9012 (K073317) | F.P. Rubinstein Y Cia S.R.L. | 2008-09-03 |
| ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10 (K082141) | Biokit, S.A. | 2008-09-03 |
| MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES (K081042) | Bsd Medical Systems Corp. | 2008-09-03 |
| GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM (K082104) | Ge Medical Systems, Inc. | 2008-09-02 |
| BT3/6, BT12 (K082077) | Corscience GmbH & Co. KG | 2008-09-02 |
| 1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION (K080711) | Hologic, Inc. | 2008-09-02 |
| RESERT XL HLD HIGH LEVEL DISINFECTANT (K080420) | STERIS Corporation | 2008-09-02 |
| RMX PHYSIOLOGICAL DATA RECORDER (K080375) | S.L.P. , Ltd. | 2008-09-02 |
| D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP) (K081821) | Global Pathogen Solutions, Inc. | 2008-09-02 |
| SNAPSHOT (K081925) | Instrumentarium Dental, Palodex Group OY | 2008-09-02 |
| HU/HS/HG PROSTHETIC SYSTEM (K081575) | Osstem Implant Co., Ltd. | 2008-09-02 |
| OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++ (K082022) | Exactech, Inc. | 2008-09-02 |
| ANTEGRA-T (K081568) | Synthes Spine Co.Lp | 2008-09-02 |
| G-IVF G5 SERIES (K081116) | Vitrolife Sweden AB | 2008-09-02 |
| VIVID I AND VIVID Q (K082374) | Ge Medical Systems Israel, Ultrasound, Ltd. | 2008-09-02 |
| GE DATEX-OHMEDA AVANCE (K081844) | Datex-Ohmeda, Inc. | 2008-08-29 |
| PERIMETRICS PERIOMETER (K072213) | Perimetrics, Inc. | 2008-08-29 |
| UNIVERSAL CLAMP STAINLESS STEEL SYSTEM (K081622) | Abbott Spine, Inc. | 2008-08-29 |
| PICOSAT II AND M3002A MULTIMEASUREMENT AND M1020B PLUG-IN MODULES SPO2 PULSE OXIMETRY MODULE (K081937) | Philips Medizin Systeme Boeblingen GmbH | 2008-08-29 |
| NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A (K080546) | Nihon Kohden America, Inc. | 2008-08-29 |
| MLCI2 (K082122) | Elekta , Ltd. | 2008-08-29 |
| MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM (K082186) | Pathway Medical Technologies, Inc. | 2008-08-29 |
| DEPUY C-STEM AMT (K082239) | DePuy Orthopaedics, Inc. | 2008-08-29 |
| FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR (K081891) | Fukuda Denshi USA, Inc. | 2008-08-29 |
| DSA 2000EX (K082341) | Eigen, LLC | 2008-08-29 |
| OTA COLLAGEN BIOMATERIAL (K073685) | Osseous Technologies of America | 2008-08-29 |
| PLANMECA SOVEREIGN (K081699) | Planmeca USA, Inc. | 2008-08-29 |
| HEALOS II BONE GRAFT SUBSTITUTE (K081432) | Depuy Spine, Inc. | 2008-08-29 |
| NORAS MR-BI320-PA 3T (K082373) | Noras Mri Products GmbH | 2008-08-29 |
| COMBOCARE 2000 (K081141) | Xanacare Technologies, LLC | 2008-08-29 |
| EXTREMITY MEDICAL COMPRESSION SCREW (K081934) | Extremity Medical, LLC | 2008-08-29 |
| DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32 (K081731) | Siemens Healthcare Diagnostics | 2008-08-29 |
| LUTE-IT II VENEER CEMENT, MODEL NO6 (K081887) | Pentron Clinical Technologies | 2008-08-29 |
| STEREOS WORKSTATION (K080529) | Biospace Med | 2008-08-29 |
| SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER (K081610) | Sysmex America, Inc. | 2008-08-29 |
| OPACITY + BONE CEMENT (K080873) | Teknimed, S.A. | 2008-08-28 |
| GENESIS (K081559) | Medisiss | 2008-08-28 |
| POWERLOC CLEAR SAFETY INFUSION SET (K082306) | C.R. Bard, Inc. | 2008-08-28 |
| SYGNAL DBM (K080405) | Musculoskeletal Transplant Foundation | 2008-08-28 |
| GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE (K082356) | W. L. Gore & Associates, Inc. | 2008-08-28 |
| CENTURION PROTECTIVE RESTRAINT, SCR SERIES (K080448) | Tri-State Hospital Supply Corp. | 2008-08-28 |
| BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO (K081550) | Bonart Co., Ltd. | 2008-08-28 |
| INOMAX DS (DELIVERY SYSTEM) (K081691) | Ino Therapeutics, LLC | 2008-08-28 |
| CLAROS NANO DENTAL LASER SYSTEM (K081652) | Elexxion AG | 2008-08-28 |
| BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK (K082132) | Bausch & Lomb, Inc. | 2008-08-28 |
| POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE (K081488) | Pt. Maja Agung Latexindo | 2008-08-28 |
| CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX (K081361) | Icu Medical, Inc. | 2008-08-28 |
| ARTHROCARE ARTHROWANDS (K082323) | Arthrocare Corp. | 2008-08-28 |
| BAHA INTENSO (K081606) | Cochlear Americas | 2008-08-28 |
| BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE (K081849) | Blackstone Medical, Inc. | 2008-08-28 |
| STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES (K081464) | Cardinalhealth | 2008-08-28 |
| SILVER ANTIMICROBIAL WOUND GEL (K073197) | Advanced Medical Solutions Limited | 2008-08-28 |
| REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C (K071023) | Reach Surgical, Inc. | 2008-08-28 |
| LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002 (K082194) | Laurimed, LLC | 2008-08-28 |
| HG OXYGEN CONCENTRATOR, MODELS HG5-W & HG5-WN (K081508) | Shenyang Canta Medical Tech. Co., Ltd. | 2008-08-27 |
| T2 XVBR SPINAL SYSTEM (K082112) | Medtronic Sofamor Danek | 2008-08-27 |
| INAREX, MODEL 2D-LX (K080554) | Inarex Corporation | 2008-08-27 |
| BOSTON SCIENTIFIC SURGICAL MESH (K081275) | Boston Scientific Corp | 2008-08-27 |
| CURBELL PATIENT MONITORING CABLES (K081762) | Curbell Electronics, Inc. | 2008-08-27 |
| MICRUS ASCENT OCCLUSION BALLOON CATHETER (K080861) | Micrus Endovascular Corporation | 2008-08-27 |
| STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635 (K082127) | Medtronic Neurosurgery | 2008-08-27 |
| SCULPTURE 2.94 ER:YAG SYSTEM (K073158) | Hoya Conbio, Inc. | 2008-08-27 |