| PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM (K073059) | Hitachi, Ltd., Power Systems Group | 2007-12-10 |
| VITEK 2 GRAM NEGATIVE PIPERACILLIN (K073083) | bioMerieux, Inc. | 2007-12-10 |
| TWINFIX FT PK (K072785) | Smith & Nephew Inc., Endoscopy Division | 2007-12-10 |
| IMPIX SPACER (K072226) | Medicrea Technologies | 2007-12-10 |
| TOTAL HIP SURGETICS NAVIGATION SYSTEM (K072267) | Praxim S.A | 2007-12-10 |
| THE CROSSER SYSTEM (K072776) | Flowcardia, Inc. | 2007-12-07 |
| AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZB (K072137) | Avita Corporation | 2007-12-07 |
| STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT (K072118) | Stryker Corp. | 2007-12-07 |
| VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2 (K073157) | Ortho-Clinical Diagnostics, Inc. | 2007-12-07 |
| DELTA SCANNER, DELTA SCANNER PRO, DS SPINE PRO, DS SPORTS PRO AND DS REHAB (K071878) | Med-Lectric Corporation | 2007-12-07 |
| LIFE+CEL BATTERY (K071164) | Amco International Manufacturing & Design, Inc. | 2007-12-07 |
| AT HOME DRUG TEST MODELS, 9308T AND 9308X (K070009) | Phamatech, Inc. | 2007-12-07 |
| ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM (K072840) | Endius, Inc. | 2007-12-07 |
| HEMAWAY SEAT (K072690) | Hemaway, LLC | 2007-12-07 |
| ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI) (K073372) | Systemsone | 2007-12-07 |
| ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0 (K070021) | Jg Medical Products, LLC | 2007-12-07 |
| SIGHTSURE OPERATIONAL INDICATOR, MODEL SS301 (K072550) | Medevice, Inc. | 2007-12-07 |
| ONEPORT SURGICAL TROCAR SYSTEM (K073009) | Conmed Corporation | 2007-12-07 |
| BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS (K070558) | C.R. Bard, Inc. | 2007-12-07 |
| ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 (K072393) | Phadia US, Inc. | 2007-12-07 |
| CINCH KNOTLESS FIXATION IMPLANT SYSTEM (K073226) | C2m Medical, Inc. | 2007-12-07 |
| BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS (K070582) | C.R. Bard, Inc. | 2007-12-07 |
| DO-ALL DENTAL HANDPIECE LUBRICANT (K073353) | Prodrive Systems, Inc. | 2007-12-07 |
| DM-EMG (K072513) | Gvp Elettronica Srl | 2007-12-07 |
| ADVIA CHEMISTRY TOTAL BILIRUBIN_2 (K063845) | Bayer Healthcare, LLC | 2007-12-07 |
| D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005 (K073264) | Vascular Solutions, Inc. | 2007-12-07 |
| CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM (K072651) | CSA Medical, Inc. | 2007-12-07 |
| HEARTWAY POWER MOBILITY SCOOTER, MODEL PT7 (K073044) | Heartway Medical Products Co., Ltd. | 2007-12-07 |
| COMPASS (K072374) | Scanditronix Wellhofer GmbH | 2007-12-07 |
| IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS (K073148) | Power Medical Interventions, Inc. | 2007-12-07 |
| TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5 (K072892) | Biosite Incorporated | 2007-12-07 |
| LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030 (K072929) | Integra LifeSciences Corporation | 2007-12-07 |
| VALENCIA SKIN APPLICATOR SET, MODEL: 189.701 (K073107) | Nucletron Corporation | 2007-12-07 |
| QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC (K070098) | Phamatech, Inc. | 2007-12-07 |
| GUIDEWIRE, MODEL G-V220-3527S AND OTHERS (K072354) | Accellent, Inc. | 2007-12-07 |
| ATHENA MULTI-LYTE GBM TEST SYSTEM (K071219) | Zeus Scientific, Inc. | 2007-12-06 |
| FASTPACK HCG IMMUNOASSAY (K072264) | Qualigen, Inc. | 2007-12-06 |
| SAN SHIH POWERED MUSCLE STIMULATOR, MODEL 202 (K071093) | San Shih Electrical Enterprise Co., Ltd. | 2007-12-06 |
| MANTIS SPINAL SYSTEM (K073151) | Stryker Corp. | 2007-12-06 |
| CARDICA C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000150 (K073123) | Cardica, Inc. | 2007-12-06 |
| SPI SYSTEM DENTAL IMPLANTS (K072649) | Thommen Medical AG | 2007-12-06 |
| CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM (K072330) | Biomet, Inc. | 2007-12-06 |
| EXPEDIUM SPINE SYSTEM (K073126) | Depuy Spine, Inc. | 2007-12-06 |
| LEGION STEM WITH HOLES (K072531) | Smith & Nephew, Inc. | 2007-12-06 |
| ORTHOGON (K073271) | Agfa Healthcare Corporation | 2007-12-05 |
| CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005 (K072558) | Cardionet, Inc. | 2007-12-05 |
| VALEO VBR (K073125) | Amedica Corp. | 2007-12-05 |
| BISICO IMPRESSION SILICONES & ALGINATES (K072577) | Bisico GmbH & CO KG | 2007-12-05 |
| SPI ART ABUTMENT (K073141) | Thommen Medical AG | 2007-12-05 |
| MEMOMETAL BONE ANCHORS (K071941) | Memometal Technologies | 2007-12-04 |
| E-1 ESTHETIC COMPOSITE SYSTEM (K072746) | Tokuyama Dental Corporation | 2007-12-04 |
| RM BOND, MODEL J032 (K072830) | Pentron Clinical Technologies | 2007-12-04 |
| STANDOUT 2 (K072622) | Kerr Corp. | 2007-12-04 |
| LEUKO EZ VUE (K071712) | Techlab Inc., Corporate Research Center | 2007-12-04 |
| MICROPROTEIN REAGENT SET (K070757) | Pointe Scientific, Inc., | 2007-12-04 |
| MILESMAN PREMIUM (K073300) | Milesman S.L. | 2007-12-04 |
| NUVASIVE COROENT SYSTEM (K071795) | Nuvasive, Inc. | 2007-12-04 |
| SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066 (K072750) | Spectranetics Corp. | 2007-12-04 |
| R-PORT II LAPAROSCOPIC ACCESS DEVICE (K073170) | Advanced Surgical Concepts | 2007-12-03 |
| SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08 (K073147) | Transoma Medical | 2007-12-03 |
| CREATININE (ENZYMATIC) (K070824) | Thermofisher Scientific OY | 2007-12-03 |
| MODIFICATION TO: LOCATOR IMPLANT ANCHOR (K072878) | Zest Anchors, Inc. | 2007-12-03 |
| EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2 (K070053) | Eps Bio Technology Corp. | 2007-12-03 |
| NEURONAV SYSTEM AND NEURONAV DRIVE (K071697) | Alpha Omega , Ltd. | 2007-12-03 |
| CRY-AC TRACKER, MODEL(S) B-700T, AND B-800T (K072453) | Brymill Corp. | 2007-12-03 |
| THERAPEUTIC MASSAGE COMPANION (K060846) | Endurance Therapeutics | 2007-12-03 |
| APL MEDICAL SYSTEM (K072344) | Bios S.R.L. | 2007-12-03 |
| SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200, SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH (K072783) | Smiths Medical Asd, Inc. | 2007-11-30 |
| INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S (K073100) | Oscor, Inc. | 2007-11-30 |
| NEOCOIL 3.0T 32-CHANNEL TORSO ARRAY COIL FOR GE (K073236) | Neocoil | 2007-11-30 |
| STRYKER STRI-SHIELD FLYTE TOGAS (K073017) | Stryker Instruments, Instruments Div. | 2007-11-30 |
| BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205 (K072325) | Jawon Medical Co., Ltd. | 2007-11-30 |
| DERMAPORT PERCUTANEOUS VASCULAR ACCESS SYSTEM (PVAS) (K071202) | Dermaport, Inc. | 2007-11-30 |
| MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039 (K070705) | Vygon Corp. | 2007-11-30 |
| SMARTCHECK INR SYSTEM (K071265) | Inverness Medical Innovations, Inc. | 2007-11-30 |
| SYNTHES VECTRA-ONE SYSTEM (K071667) | Synthes Spine | 2007-11-30 |
| FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT (K070900) | The Binding Site, Ltd. | 2007-11-30 |
| COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT (K070015) | Biomet Manufacturing Corp | 2007-11-30 |
| ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H (K072115) | Horiba Abx | 2007-11-30 |
| CONTINUOUS NON-INVASIVE CARDIAC OUTPUT AND BLOOD PRESSURE MONITOR WITH REAL-TIME HEMODYNAMICS (K072049) | Bmeye B.V. | 2007-11-29 |
| STERRAD 100NX STERILIZER (K071385) | Advanced Sterilization Products | 2007-11-29 |
| CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K073060) | Innova Vision, Inc. | 2007-11-29 |
| RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25 (K072194) | Renu Medical, Inc. | 2007-11-29 |
| SA-3000P (K073323) | Medicore Co., Ltd. | 2007-11-29 |
| MOBIL-O-GRAPH NG 24 H ABP-CONTROL (K072446) | I.E.M. GmbH | 2007-11-29 |
| PM-7000 PATIENT MONITOR (K072346) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007-11-29 |
| TEPHAFLEX SURGICAL FILM (K072520) | Tepha, Inc. | 2007-11-29 |
| YG-125T AND YG-135T NASAL ADAPTER (K072843) | Nihon Kohden America, Inc. | 2007-11-29 |
| CARESCAPE V100 (K073203) | Ge Medical Systems Information Technologies | 2007-11-29 |
| HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY (K072482) | Smiths Medical Asd, Inc. | 2007-11-29 |
| HABIB ENDOBLATE (K072383) | Emcision , Ltd. | 2007-11-29 |
| SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM (K072463) | Satyrne Medical | 2007-11-29 |
| PARI HYDRATE V (K072982) | Pari Innovative Manufacturers, Inc. | 2007-11-29 |
| CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS (K072449) | Welch Allyn, Inc. | 2007-11-29 |
| SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM (K072578) | Synthes (Usa) | 2007-11-28 |
| SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIES (K072672) | Abbott Spine, Inc. | 2007-11-28 |
| 3S HEMI TOE (K072922) | Trilliant Surgical, Ltd. | 2007-11-28 |
| GYN DISPOSABLES TENACULUM 356T (K073182) | Gyn-Disposables, Inc. | 2007-11-28 |
| IMPLUS IMPLANT SYSTEM (K062931) | Leader Italia S.R.L. | 2007-11-28 |
| NOVEON, MODEL LS1100-01-0968 (K071815) | Nomir Medical Technologies, Inc. | 2007-11-28 |