| HERCULITE ULTRA (K082671) | Sybron Dental Specialties | 2008-12-11 |
| SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS (K082561) | Spectranetics Corp. | 2008-12-10 |
| UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV (K071526) | Impact Instrumentation, Inc. | 2008-12-10 |
| MODIFICATION TO ARTHROCARE ARTHROWANDS (K083306) | Arthrocare Corp. | 2008-12-10 |
| DISPOSABLE VINYL SYNTHETIC EXAMINATION GLOVES, POWDERED (K082448) | Rich Mountain Medical Products, Inc. | 2008-12-10 |
| TAIDOC TD-11 SERIES AND CLEVER TD-1112 EAR/SKIN/ SURFACE IR THERMOMETERS & FORA IR16/17 EAR THERMOMETER (K083299) | Taidoc Technology Corporation | 2008-12-10 |
| PASS LP SPINAL SYSTEM (K083308) | Medicrea Technologies | 2008-12-10 |
| RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES (K082902) | Rz Medizintechnik GmbH | 2008-12-10 |
| EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT (K080810) | Medica Corp. | 2008-12-10 |
| DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426 (K071474) | Siemens Healthcare Diagnostics | 2008-12-10 |
| PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001 (K083013) | Gyrus Acmi, Inc. | 2008-12-09 |
| FREEWAY AND RAILRUNNER GUIDEWIRES (K082922) | Lake Region Mfg., Inc. | 2008-12-09 |
| GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP (K080022) | Vascular Solutions, Inc. | 2008-12-09 |
| NANOBEAM 940, MODEL 940-900-02 (K073681) | Davaray, Inc. | 2008-12-09 |
| RUGALIFT, MODEL# V.2.1 (K071573) | Fatrotek S.R.L. | 2008-12-09 |
| TEMPORARY COLD.V AND SELF-CURE DENTINE (K082700) | Major Prodotti Dentari S.P.A. | 2008-12-09 |
| AGILIS NXT STEERABLE INTRODUCER, MODEL G408324 (K081645) | St Jude Medical | 2008-12-09 |
| MEDEGEN PRESSURE RATED EXTENSION SETS (K083472) | Medegen, Inc. | 2008-12-09 |
| BUSSE SURGICAL DRAPE (K082297) | Busse Hospital Disposables, Inc. | 2008-12-09 |
| NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT (K082672) | Novabone Products, LLC | 2008-12-09 |
| MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR (K082308) | Edwards Lifesciences, LLC | 2008-12-09 |
| ZOLL R SERIES BLS DEFIBRILLATOR (K081828) | ZOLL Medical Corporation | 2008-12-09 |
| POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM (K082302) | Pt. Medisafe Technologies | 2008-12-09 |
| ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY (K080428) | Medtronic, Inc. | 2008-12-09 |
| HAV-LOK BUNION CORRECTION SYSTEM (K082384) | Instratek, Inc. | 2008-12-08 |
| MAXTORQUE MINI CANNULATED SCREW SYSTEM (K082574) | Orthohelix Surgical Designs, Inc. | 2008-12-08 |
| MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00 (K080499) | The Magstim Company , Ltd. | 2008-12-08 |
| SPECTRA GUIDEWIRE INTRODUCER NEEDLE (K082580) | Spectra Medical Devices, Inc. | 2008-12-08 |
| ELECSYS RUBELLA IGG IMMUNOASSAY (K072617) | Roche Diagnostics Corp. | 2008-12-05 |
| MRI-PLAQUE VIEW, VERSION 1.1.2003 (K082607) | Vpdiagnostics, Inc. | 2008-12-05 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DOXYCYCLINE (GP) 0.25-16 UG/ML (K082913) | Becton, Dickinson & CO | 2008-12-05 |
| FLEXITIME BITE (K082591) | Heraeus Kulzer, Inc., Dental Products Division | 2008-12-05 |
| DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B (K082001) | Diazyme Laboratories | 2008-12-05 |
| HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F (K081073) | Pausch, LLC | 2008-12-05 |
| CELLAVISION DM96 WITH THE BODY FLUID APPLICATION (K080595) | CellaVision AB | 2008-12-05 |
| LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV (K082049) | DiaSorin, Inc. | 2008-12-05 |
| PRAGER SHELL (K082893) | Esi, Inc. | 2008-12-05 |
| LUBRICANO STERILE GEL (K081990) | Farco Pharma GmbH | 2008-12-05 |
| MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR (K083029) | Ralco S.R.L. | 2008-12-05 |
| BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY (K081522) | Bio Nuclear Diagnostics, Inc. | 2008-12-05 |
| KODAK 9500 (K082972) | Trophy | 2008-12-05 |
| ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150) (K083086) | Hitachi Medical Systems America, Inc. | 2008-12-05 |
| VIATRONIX V3D-CARDIAC, REVISION 1.0 (K083293) | Viatronix, Inc. | 2008-12-05 |
| STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS (K080558) | Case Medical, Inc. | 2008-12-05 |
| STARBAND (K082950) | Orthomerica Products, Inc. | 2008-12-05 |
| APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM (K082387) | American Medical Systems | 2008-12-04 |
| ALLOFUSE GEL AND PUTTY (K071849) | Allosource, Inc. | 2008-12-04 |
| THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006 (K081697) | Access Scientific, Inc. | 2008-12-04 |
| INTEGRA MESHED BILAYER WOUND MATRIX (K081635) | Integra Lifesciences Corp. | 2008-12-04 |
| DEPUY ASPHERE M-SPEC HEAD (K082585) | DePuy Orthopaedics, Inc. | 2008-12-04 |
| MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET (K082670) | Medtronic, Inc. | 2008-12-04 |
| PRO GLUCOSE TEST STRIP (K082169) | Taidoc Technology Corporation | 2008-12-04 |
| OMNI-TIGHT (K082749) | Basic Dental Implant Systems, Inc. | 2008-12-04 |
| NANOCORSS .014 OTW PTA DILATATION CATHETER (K082854) | Ev3, Inc. | 2008-12-04 |
| TIVAMED COOLED RF SYSTEM, MODEL 78001 (K082962) | Tivamed, Inc. | 2008-12-04 |
| ZOLL E SERIES WITH INTIBATION ASSIST OPTION (K080903) | ZOLL Medical Corporation | 2008-12-04 |
| HOLTER LX ANALYSIS (K081861) | North East Monitoring, Inc. | 2008-12-04 |
| NUOVOCATH (K083454) | U.S. Safety Syringes Co., Inc. | 2008-12-04 |
| HEADWAY 17 MICROCATHETER (K083343) | MicroVention, Inc. | 2008-12-04 |
| MICROWARE BONE PLATES AND BONE SCREWS (K072562) | Microware Precision Co., Ltd. | 2008-12-04 |
| SUINSA DIAGNOSTIC X-RAY SYSTEM (K083109) | Suinsa | 2008-12-04 |
| ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS (K080485) | Diasys Diagnostics Systems GmbH | 2008-12-04 |
| VISION WIRE CORONARY GUIDEWIRE (K082935) | Biotronik, Inc. | 2008-12-04 |
| LIPOSE FAT TRANSFER SYSTEM (K081848) | Lipose Corp. | 2008-12-04 |
| 2-PORT THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT (K081739) | Boston Scientific Corp | 2008-12-03 |
| MERCURY SPINAL SYSTEM (K083230) | Spinal Elements, Inc. | 2008-12-03 |
| 15W CERALAS D 1470NM DIODE LASER, MODEL D1470 (K082225) | Biolitec, Inc. | 2008-12-03 |
| VICARDIO 12B (K082380) | Energy-Lab Technologies GmbH | 2008-12-03 |
| NO!NO! SKIN (K082423) | Radiancy (Israel) , Ltd. | 2008-12-03 |
| PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES (K082786) | Peak Surgical, Inc. | 2008-12-03 |
| LEDEX, MODEL: WL-070 (K082408) | Dentmate Technology Co. , Ltd. | 2008-12-03 |
| POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES (K081592) | Quality Gallant Sdn. Bhd. | 2008-12-03 |
| MARK 5 NUVO LITE OCSI AND STD (K082566) | Nidek Medical Products, Inc. | 2008-12-03 |
| REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT FINGER CLIP SENSOR, PHILLIPS ADULT SOFT TIP SENSOR(U403S-91) (K082546) | Unimed Medical Supplies, Inc. | 2008-12-02 |
| MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT (K082539) | Cardinal Health Germany 234 GmbH | 2008-12-02 |
| ZIOCERA & CONVERTIBLE SYSTEM (K081786) | Osstem Implant Co., Ltd. | 2008-12-02 |
| PROSIT WOUND TREATMENT DEVICE (K081977) | Silverleaf Medical Products, Inc. | 2008-12-01 |
| VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600 (K082456) | Verathon Incorporated | 2008-12-01 |
| COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE (K082535) | Surgical Devices, A Global Business Unit Covidien | 2008-12-01 |
| DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER (K082208) | Scivolutions, Inc. | 2008-12-01 |
| MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458 (K082011) | Bio-Medical Research, Ltd. | 2008-11-28 |
| MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM (K082172) | Mako Surgical Corporation | 2008-11-28 |
| SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE (K082674) | Spectra Medical Devices, Inc. | 2008-11-28 |
| DDS STABILIZATION SYSTEM (K080241) | Paradigm Spine, LLC | 2008-11-28 |
| TABATABA COTESTER (K080278) | Fim Medical | 2008-11-28 |
| GE ENTROPY SENSOR (K082540) | GE Healthcare | 2008-11-28 |
| MODIFICATION TO INTEL HEALTH GUIDE, MODEL PHS6000 (K083115) | Intel Corp. | 2008-11-26 |
| SI JOINT FUSION SYSTEM (K080398) | SI-BONE, Inc. | 2008-11-26 |
| QV-9000 UNIVERSAL SYSTEM (K083181) | Quantum Medical Imaging, LLC | 2008-11-26 |
| CARDIO-VIEW (K083321) | Curlview Igt, LLC | 2008-11-26 |
| NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES (K082785) | Nihon Kohden America, Inc. | 2008-11-26 |
| QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200 (K083078) | Quanta Computer, Inc. | 2008-11-26 |
| GC AADVA ZR DISK (K082740) | GC America, Inc. | 2008-11-26 |
| VERITAS COLLAGEN MATRIX (DRY) (K083039) | Synovis Surgical Innovations | 2008-11-26 |
| INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997 (K082888) | Draeger Medical Systems, Inc. | 2008-11-26 |
| RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT) (K081975) | Abbott Diabetes Care, Inc. | 2008-11-26 |
| OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082) (K082600) | Draeger Medical B.V. | 2008-11-26 |
| OMNI-DL SYSTEM (K080650) | Transvivo, Inc. | 2008-11-26 |
| AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE (K082730) | American Medical Systems, Inc. | 2008-11-26 |
| HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM (K082541) | Medi Nuclear Corp., Inc. | 2008-11-26 |