| LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE (K083340) | Levitronix, LLC | 2008-11-26 |
| RAPIDVIT AND RAPIDWARM CLEAVE (K080446) | Vitrolife Sweden AB | 2008-11-26 |
| FETAL & MATERNAL MONITOR, MODEL F6, F9 (K082602) | Edan Instruments, Inc. | 2008-11-26 |
| KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODEL ESSENTIAL CONE 1.5 (K082200) | SOADCO, S.L. | 2008-11-25 |
| ORLUS MINI SCREW (K082838) | Ortholution Co., Ltd. | 2008-11-25 |
| VALLEYLAB MICROWAVE ABLATION GENERATOR (K072687) | Covidien Lp, Formerly Know AS Valleylab, A Divison | 2008-11-25 |
| BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE (K082844) | Encore Medical L.P. | 2008-11-25 |
| VIPERSPHERE PTA BALLOON CATHETER (K083139) | Cardiovascular Systems, Inc. | 2008-11-25 |
| MAJOR.REPAIR (K082153) | Major Prodotti Dentari S.P.A. | 2008-11-25 |
| PRODIGY NPWT SYSTEM MODEL PRODIGY 800V (K082415) | Premco Medical Systems, Inc. | 2008-11-25 |
| BODYSTAT 1500 BODY COMPOSITION MONITORING UNIT (K082253) | Bodystat , Ltd. | 2008-11-25 |
| ENTERAL ONLY EXTENSION SET (K082654) | Respironics, Inc. | 2008-11-25 |
| ORTHOPEDIATRICS BONE SCREWS (K082949) | OrthoPediatrics Corp. | 2008-11-25 |
| ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES (K082575) | Apatech , Ltd. | 2008-11-25 |
| SMITH & NEPHEW, INC. PATIENT MATCHED TECHNOLOGY (K082358) | Smith & Nephew, Inc. | 2008-11-25 |
| BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC, (K080467) | Applied Dna Technologies, Inc. | 2008-11-25 |
| AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561 (K082861) | Amco International Manufacturing & Design, Inc. | 2008-11-25 |
| ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106 (K082655) | Envitec-Wismar GmbH | 2008-11-25 |
| MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0 (K081867) | Mako Surgical Corp. | 2008-11-25 |
| POGO SCREW (K080649) | Fxdevices | 2008-11-25 |
| PHILIPS INTELLIVUE MP5 PATIENT MONITOR (K083228) | Philips Medizin Systeme Boblingen GmbH | 2008-11-24 |
| SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION PLATE SYSTEM WITH EXPANDED INDICATIONS (K082807) | Synthes (Usa) | 2008-11-24 |
| WU'S 4-WHEELED NEO SCOOTER, WT-M3A (K082963) | Wu'S Tech Co., Ltd. | 2008-11-24 |
| MODEL ES-130 (K081943) | Ito Co., Ltd. | 2008-11-24 |
| USS ILIOSACRAL, USS POLYAXIAL (K082572) | Synthes Spine | 2008-11-24 |
| MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP O3 (K082881) | Microlife Intellectual Property GmbH | 2008-11-24 |
| PROGENIX PLUS (K082002) | Medtronic Sofamor Danek | 2008-11-24 |
| FUTURABOND M/FUTURABOND M SINGLE DOSE (K082753) | Voco GmbH | 2008-11-24 |
| ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000 (K083146) | Asahi Intecc Co., Ltd. | 2008-11-21 |
| TDS ABUTMENT (K081460) | Pou YU Biotechnology Co., Ltd. | 2008-11-21 |
| NEURON SELECT CATHETER SIZE 070 (K083125) | Penumbra, Inc. | 2008-11-21 |
| STOMA BONE BLOCK SCREW (K080430) | Storz AM Mark GmbH | 2008-11-21 |
| REXASTOM ORAL EASE (K082553) | Rexaderm, Inc. | 2008-11-21 |
| CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM (K082432) | Bioptics, Inc. | 2008-11-21 |
| DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS (K073390) | DiaSorin, Inc. | 2008-11-21 |
| 16CH AI BREAST COILS 1.5 T AND 3 T (K083255) | Rapid Biomedical GmbH | 2008-11-21 |
| NEORAY DR 2520 DIGITAL IMAGING SYSTEM (K083048) | Portavision Medical, LLC | 2008-11-21 |
| GE LUNAR FEMUR STRENGTH SOFTWARE (K072664) | Ge Medical Systems Ultrasound and Primary Care Dia | 2008-11-21 |
| VIZTEK DR, MODELS: DR1000, DR3000, DR4000 (K082604) | Viztek, Inc. | 2008-11-21 |
| N-DEX FREE NIGHTHAWK BLACK NITRILE MEDICAL EXAMINATION GLOVE, POWDER -FREE, MODEL# 7700PFT (K082125) | Best Glove, Inc. | 2008-11-21 |
| ISOELASTICU (K081025) | Remi Sciences, Inc. | 2008-11-21 |
| FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD (K082508) | Branan Medical Corporation | 2008-11-21 |
| VERTEBRAL ACCESS SYSTEM BY VIDACARE (K081713) | Vidacare Corporation | 2008-11-21 |
| TSRH SPINAL SYSTEM (K081080) | Medtronic Sofamor Danek | 2008-11-21 |
| NORDICICE SOFTWARE (K082441) | Nordicimaginglab AS | 2008-11-21 |
| STERI-LUB LUBRICATION GEL (K083189) | Avail Medical Products, Inc. | 2008-11-21 |
| SAPPHIRE PLASMA ARC DENTAL CURING LIGHT (K081287) | Den-Mat Holdings, LLC | 2008-11-21 |
| JARIT HULKA UTERINE TENACULUM FORCEPS (K082349) | J. Jamner Surgical Instruments, Inc. | 2008-11-21 |
| SYMBIA, VERSION 4.0 (K082506) | Siemens Medical Solutions USA, Inc. | 2008-11-21 |
| INFINITT XELIS (K082990) | Infinitt Co., Ltd. | 2008-11-20 |
| FACTOR VIII ANTIBODY SCREEN (K082205) | Genetic Testing Institute | 2008-11-20 |
| VERICORE IMPLANT ABUTMENTS (K082299) | Whip-Mix Corp. | 2008-11-20 |
| EVERCROSS .035 OTW PTA DILATATION CATHETER (K082579) | Ev3, Inc. | 2008-11-20 |
| BIOLOX DELTA CERAMIC FEMORAL HEAD (K082991) | Aesculap Implant Systems, Inc. | 2008-11-20 |
| ENABLER-P SUPPORT CATHETER (K082339) | Endocross, Ltd. | 2008-11-20 |
| STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836 (K083076) | Medtronic Neurosurgery | 2008-11-20 |
| SNTRYPACS (K082240) | Qstar Technologies, Inc. | 2008-11-20 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE RESISTANCE TEST (K082538) | Becton, Dickinson & CO | 2008-11-20 |
| CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23 (K082628) | Circle Cardiovascular Imaging, Inc. | 2008-11-20 |
| AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM (K082284) | Alveolus, Inc. | 2008-11-20 |
| EMG TRITON -COMP,MODEL NCA01-XXX SERIES (K072634) | Emg Technology Co., Ltd. | 2008-11-19 |
| NITI-S BILIARY STENT (K073667) | Taewoong Medical Co., Ltd. | 2008-11-19 |
| THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS (K081380) | K2m, Inc. | 2008-11-19 |
| GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP (K083100) | Nobel Biocare USA, LLC | 2008-11-19 |
| STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331 (K082773) | Standard Imaging, Inc. | 2008-11-19 |
| THERAGEM PROFESSIONAL T1002 (K081505) | Medica Health, Ltd. | 2008-11-19 |
| AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5 (K082714) | Aalto Scientific, Ltd. | 2008-11-19 |
| MULTLINK CABLE AND LEADWIRE SYSTEM (K082851) | Ge Medical Systems Information Technologies | 2008-11-19 |
| SH14 HEMOCONCENTRATOR (K081313) | Sorin Group Italia S.R.L. | 2008-11-19 |
| IC-PRO SYSTEM, VERSION 3.1.0.4 (K082907) | Paieon, Inc. | 2008-11-18 |
| AVALON ELITE VASCULAR ACCESS KIT (K081940) | Avalon Laboratories, LLC | 2008-11-18 |
| VIDA PULMONARY WORKSTATION 2 (PW2) (K083227) | Vida Diagnostics, Inc. | 2008-11-18 |
| LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG (K081685) | DiaSorin, Inc. | 2008-11-18 |
| DIGITAL RADIOGRAPHY, FLEXDR C30 (K082347) | Konica Minolta Technoproduct Co., Ltd. | 2008-11-18 |
| NON-CONTACT TONOMETER, MODEL FT-1000 (K073087) | Tomey Corporation | 2008-11-18 |
| FIBERNET EMBOLIC PROTECTION SYSTEM (K082348) | Lumen Biomedical, Inc. | 2008-11-18 |
| SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL (K082650) | Synthes (Usa) | 2008-11-18 |
| SYNTHEMED DEVICE (K082276) | Synthemed, Inc. | 2008-11-18 |
| STEREO NAVIGATOR ACCESSORY, STN-1000 (K082354) | Naviscan Pet Systems | 2008-11-18 |
| DEPUY SIGMA CR-F FEMORAL COMPONENT (K082500) | DePuy Orthopaedics, Inc. | 2008-11-18 |
| EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT (K080823) | Medica Corp. | 2008-11-17 |
| SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE (K082568) | Bovie Medical | 2008-11-17 |
| CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA (K080623) | Jas Diagnostics, Inc. | 2008-11-17 |
| LANG DENTAL ACRYLIC PRIMER (K081981) | Lang Dental Mfg. Co., Inc. | 2008-11-17 |
| SRI LP DRAPE (K080796) | Sri/Surgical Express | 2008-11-17 |
| C-QUEST (K082581) | Medx, Inc. | 2008-11-14 |
| PROTEX CT CERVICOTHORACIC SPINAL SYSTEM (K081906) | Globus Medical, Inc. | 2008-11-14 |
| ULTRAWAVE III EX 1320 (K083207) | Quanta System Spa | 2008-11-14 |
| RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS (K082211) | Smith & Nephew, Inc. | 2008-11-14 |
| NEXUS I.V. NEEDLESS ACCESS CANNULA FOR INTRAVASCULAR ADMINISTRATION SETS (K081123) | Nexus Medical, LLC | 2008-11-14 |
| TANDA SKINCARE SYSTEM, MODEL: PTSCS (K080591) | Pharos Life Corporation | 2008-11-14 |
| LTM-BPS SURGICAL MESH (K082176) | Lifecell Corp. | 2008-11-14 |
| SYNGO IMAGING XS (K082430) | Siemens AG Medical Solutions | 2008-11-14 |
| DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE (K081673) | Ionics Medical Corp. | 2008-11-14 |
| TENACORE OXYGEN BLENDER, MODEL TB-2000 (K081335) | Tenacore Holdings, Inc. | 2008-11-14 |
| AIR ASSISTED SPRAYER, MODELS: AIRSPRAYUS01 AND AIRSPRAYUS (K082322) | Covidien | 2008-11-14 |
| GDLS-200 (K082434) | GC America, Inc. | 2008-11-14 |
| VERTEX RECONSTRUCTION SYSTEM (K083071) | Medtronic Sofamor Danek | 2008-11-14 |
| DEPUY SPINE LATERAL CAGE SYSTEM (K082128) | Depuy Spine | 2008-11-14 |
| SPECTRAL OCT/SLO (K080460) | Opko Health, Inc. | 2008-11-14 |