| ELUTIA COATED CLOSED SURGICAL WOUND DRAIN (K063245) | Bacterin International, Inc. | 2007-11-28 |
| IST ANTERIOR CERVICAL PLATE SYSTEM (K072650) | Innovative Spinal Technologies, Inc. | 2007-11-28 |
| MODIFICATION TO APERFIX FEMORAL IMPLANT WITH INSERTER (K073054) | Cayenne Medical, Inc. | 2007-11-27 |
| BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS (K073102) | Biomet Manufacturing Corp | 2007-11-27 |
| EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR (K071624) | Everlife Medical Equipment Co., Ltd. | 2007-11-27 |
| NUFACE, MODEL NU-4003 (K072260) | Carol Cole Company | 2007-11-27 |
| MODELS EMS 5.0, EMS 5.1 (K072795) | Koalaty Products, Inc. | 2007-11-27 |
| RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE (K072827) | Remel, Inc. | 2007-11-26 |
| DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM (K072921) | Symbios Medical Products, LLC | 2007-11-26 |
| FUNHALER, MODEL V-201E (K072822) | Infamed , Ltd. | 2007-11-26 |
| MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR (K072780) | Ralco S.R.L. | 2007-11-26 |
| MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP (K062575) | Princeton BioMeditech Corp. | 2007-11-26 |
| PRIMUS A1CARE ASSAY (K062658) | Primus Corp. | 2007-11-26 |
| CSF AUTOMATED CONTROL, MODELS CSF001, CSF003 (K072846) | R&D Systems, Inc. | 2007-11-26 |
| DISPENSER DP 20 (K071588) | NOUVAG AG | 2007-11-26 |
| PRO-PICC, BASIC TRAY; LONG WIRE TRAY; BASIC NURSING TRAY; FULL NURSING TRAY (K072509) | Medcomp | 2007-11-26 |
| HAMILTON-G5 (K070513) | Hamilton Medical AG | 2007-11-26 |
| RT300-S AND RT300-SP FES CYCLE ERGOMETER (K072398) | Restorative Therapies, Inc. | 2007-11-21 |
| REVEAL XT; INSERTABLE CARDIAC MONITOR (MODEL 9529), PATIENT ASSISTANT (MODEL 9539) (K071641) | Medtronic, Inc. | 2007-11-21 |
| MONOJECT HYPODERMIC NEEDLE, MODEL 250, 30 GAUGE HYPODERMIC NEEDLE (K073122) | Covidien Lp, Formerly Registered AS Tyco Healthcar | 2007-11-21 |
| IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UNV 4K (K072867) | Imix Adr Finland OY | 2007-11-21 |
| NEOCOIL 1.5T 16 CHANNEL CARDIAC-ABDOMINAL-PELVIC ARRAY COIL (K073181) | Neocoil, LLC | 2007-11-21 |
| AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER (K071406) | United States Surgical, A Division of Tyco Healthc | 2007-11-21 |
| THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS (K071958) | Smiths Medical Asd, Inc. | 2007-11-21 |
| PADNET+ (K073146) | Biomedix, Inc. | 2007-11-21 |
| VITALOGIK MODEL 4000/4500 (K073140) | Mennen Medical , Ltd. | 2007-11-21 |
| GENERATION 8 SE ADHESIVE (K072480) | Pentron Clinical Technologies | 2007-11-21 |
| TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM (K071521) | Terumo Cardiovascular Systems Corp. | 2007-11-21 |
| MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT (K071927) | Depuy Spine, A Johnson & Johnson Company | 2007-11-21 |
| TWIN-PASS OTW CATHETER, MODEL 5201 (K072618) | Vascular Solutions, Inc. | 2007-11-21 |
| PHLEBOPRESS MODEL 601A COMPRESSION THERAPY DEVICE (K072372) | Mego Afek | 2007-11-21 |
| JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X (K073081) | Toshiba America Medical Systems, In.C | 2007-11-21 |
| CTU676 DEVICE (K073013) | Compression Technologies Unlimited, Inc. | 2007-11-21 |
| FIDELITY 200 CARDIAC EVENT RECORDER (K071228) | Signalife, Inc. | 2007-11-21 |
| MRI SYSTEM, MODEL MAGFINDER II / AI 3200 (K072850) | Advanced Imaging Laboratory | 2007-11-21 |
| REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538 (K071655) | Medtronic, Inc. | 2007-11-21 |
| I LIGHT (K072807) | Dent'N CO | 2007-11-21 |
| NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF) POROUS FEMORAL COMPONENTS (K072619) | Zimmer, Inc. | 2007-11-21 |
| ZENO ZR DISC (K073108) | Wieland Dental + Technik GmbH & Co. KG | 2007-11-21 |
| COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH (K072521) | Cook Urological, Inc. | 2007-11-20 |
| IMPLANTIUM PROSTHETICS (K070228) | Dentium Co., Ltd. | 2007-11-20 |
| SYSMEX XE-5000 (K071967) | Sysmex America, Inc. | 2007-11-20 |
| BIS EEG VISTA MONITOR SYSTEM AND BISX (K072286) | Aspect Medical Systems, Inc. | 2007-11-20 |
| IMMUNOCAP THYRLOBULIN IMMUNOCAP (K072661) | Phadia US, Inc. | 2007-11-20 |
| AVAFLEX VERTEBRAL AUGMENTATION NEEDLE (K072133) | Cardinal Health, Inc. | 2007-11-20 |
| BBL CHROMAGAR 0157 (K070691) | Becton, Dickinson & CO | 2007-11-20 |
| INTEGRADWEB PACS SYSTEM (K072986) | GE Healthcare | 2007-11-20 |
| PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS (K073035) | Merit Medical Systems, Inc. | 2007-11-20 |
| FMRI HARDWARE SYSTEM (K073099) | Nordicneurolab | 2007-11-20 |
| CELLSEARCH CIRCULATING TUMOR CELL KIT (K071729) | Veridex, LLC | 2007-11-20 |
| TC-PLUS PRIMARY KNEE SYSTEM (K072858) | Smith & Nephew, Inc. | 2007-11-20 |
| HEMOSTASIS VALVE (K072556) | Merit Medical Systems, Inc. | 2007-11-20 |
| HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S (K072268) | R&D Systems, Inc. | 2007-11-20 |
| PEF TUBE (K071579) | N.M. Beale Co., Inc. | 2007-11-20 |
| MICROLUX/BLU (K072309) | Addent, Inc. | 2007-11-19 |
| BIOLOX DELTA CERAMIC FEMORAL HEAD (K071535) | Zimmer, Inc. | 2007-11-19 |
| PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS (K072818) | Smith & Nephew, Inc. | 2007-11-19 |
| YUYUAN LATEX EXAMINATION GLOVE, POWDERED (K072639) | Shandong Yuyuan Latex Gloves Company , Ltd. | 2007-11-19 |
| BRIO ACUPUNCTURE NEEDLES (K072778) | Helio Medical Supplies, Inc. | 2007-11-19 |
| PFM PICC (K072391) | Pfm Medical, Inc. | 2007-11-19 |
| RIGI-FIX HIP STEM SYSTEM (K072101) | Implants Intl. , Ltd. | 2007-11-19 |
| CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01) (K072202) | Biosense Webster, Inc. | 2007-11-19 |
| SMARTSPONGE PLUS SYSTEM (K073180) | Clearcount Medical Solutions, Inc. | 2007-11-19 |
| COPA AMD ANTIMICROBIAL WOUND DRESSING (K071371) | Tyco Healthcare Group LP | 2007-11-19 |
| IMPLANT CENTER (K072030) | Satelec - Acteon Group | 2007-11-19 |
| CAP PLUS (K063050) | Etex Corp. | 2007-11-19 |
| MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM (K072502) | Ge Medical Systems Information Technologies | 2007-11-19 |
| VALEO PEDICLE SCREW SPINAL SYSTEM (K072022) | Amedica Corp. | 2007-11-19 |
| MONDEAL EXTREMITY BONE FIXATION SYSTEM (K072740) | Mondeal Medical Systems GmbH | 2007-11-19 |
| PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS (K073032) | Lifecore Biomedical, Inc. | 2007-11-16 |
| LUMACARE MODEL LC-122M NON-COHERENT LIGHT SOURCE AND MODEL LUM-P FIBRE OPTIC PROBE (K072048) | Lynton Lasers Limited | 2007-11-16 |
| SKINTACT AND VARIOUS OTHER TRADENAMES (K073104) | Leonhard Lang GmbH | 2007-11-16 |
| DUO TEMP (K072604) | Coltene/Whaledent AG | 2007-11-16 |
| INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS) (K071921) | Innovasis, Inc. | 2007-11-16 |
| GE ECHOPAC (K072952) | General Electric Co. | 2007-11-16 |
| DRAD-3000E, RADREX-I (K073165) | Toshiba America Medical Systems, In.C | 2007-11-16 |
| COLLIMARE COLLIMATOR FAMILY (K073124) | Collimare, LLC | 2007-11-16 |
| LBS-63-16 BREAST ARRAY COIL (K072873) | Invivo | 2007-11-16 |
| THE LIFE VESSEL (K070690) | Cottonwood Vessel Corporation | 2007-11-16 |
| INTERSTITIAL NEEDLES (K073133) | Varian Medical Systems, Inc. | 2007-11-16 |
| CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US (K072643) | Olympus Corporation | 2007-11-16 |
| THERMOFORM SHEET MATERIALS AND ACCESSORIES (K072522) | Dentsply International, Inc. | 2007-11-16 |
| LBS-127-16 BREAST ARRAY COIL (K072874) | Invivo | 2007-11-16 |
| SOPRO 225 DUAL HALOGEN LIGHT SOURCE (K072912) | Sopro | 2007-11-16 |
| VITEK 2 GRAM POSITIVE TIGECYCLINE (K072695) | bioMerieux, Inc. | 2007-11-16 |
| BIOELAST 5-0 SUTURE, MODEL 500100 (K072470) | Entrigue Surgical, Inc. | 2007-11-16 |
| HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM (K072946) | Empi | 2007-11-16 |
| FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM (K071127) | Vision-Sciences, Inc. | 2007-11-16 |
| GALEMED CPAP MASK (K072755) | Galemed Corp. | 2007-11-16 |
| A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I (K073134) | Invacare Corporation | 2007-11-16 |
| CONFIDANT 2.5 (K072698) | Confidant, Inc. | 2007-11-16 |
| ENDOSSEOUS DENTAL IMPLANT SYSTEM (K071161) | Southern Implants, Inc. | 2007-11-16 |
| ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN MICROAMINI IMPLANTS, GEMINI ABUTMENT IN ZIRCONIA FOR ASTRA IMPLANTS (K072483) | Atlantis Components, Inc. | 2007-11-16 |
| COLPO-MASTER (K073053) | United Products & Instruments, Inc. | 2007-11-15 |
| RAD VISION, MODELS E AND EU (K072659) | Almana Medical Imaging | 2007-11-15 |
| CHOY COMPRESSION FRAME (K070968) | Choy Medical Technologies, Inc. | 2007-11-15 |
| SPI CONTACT PLATFORM O 4.0 MM (K072933) | Thommen Medical AG | 2007-11-15 |
| BIOXTRA MOISTURIZING GEL (K072306) | Bio-X Healthcare S.A. | 2007-11-15 |
| UNIDUS MAGNUM MALE LATEX CONDOM (K072747) | Unidus Corp. | 2007-11-15 |
| XPOD/XMAP NERVE STIMULATOR (K072092) | Xavant Technology (Pty), Ltd. | 2007-11-15 |