| HEALTHEPOD (K083174) | Card Guard Scientific Survival , Ltd. | 2009-12-17 |
| GALILEOS IMPLANT, VERSION 1.7 (K093090) | Sicat GmbH & Co. KG | 2009-12-17 |
| Xpert VanA Assay (K092953) | Cepheid | 2009-12-17 |
| ATLANTIS HYPERBARIC CHAMBER VENTILATOR (K092264) | Providence Global Medical, Inc. | 2009-12-17 |
| TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE (K093397) | MicroVention, Inc. | 2009-12-17 |
| FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER (K093252) | Footprint Medical, Inc. | 2009-12-17 |
| DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS (K093646) | DePuy Orthopaedics, Inc. | 2009-12-17 |
| SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX (K093546) | Togo Medikit Co., Ltd. | 2009-12-17 |
| AQUACEL AG SURGICAL (K091034) | Convatec | 2009-12-16 |
| STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150 (K092912) | Danville Materials, Inc. | 2009-12-16 |
| ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP (K093084) | Rolence Ent., Inc. | 2009-12-16 |
| MODIFICATION TO CASPIAN SPINAL SYSTEM (K093534) | K2m, Inc. | 2009-12-16 |
| IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM (K093513) | Conformis, Inc. | 2009-12-16 |
| FOOT AND HAND MOTION SYSTEM (K091118) | Newclip Technics | 2009-12-16 |
| E.COLI/P. AERUGINOSA PNA FISH (K092236) | Advandx, Inc. | 2009-12-16 |
| SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES (K092445) | Trek Diagnostic Systems, Ltd. | 2009-12-16 |
| DOSE VOLUME HISTOGRAM (DVH) EVALUATOR (K092928) | Diversilabs, LLC | 2009-12-16 |
| INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200, IS2000 AND IS3000 (K090993) | Intuitive Surgical, Inc. | 2009-12-16 |
| BINAXNOX STAPHYLOCOCCUS AUREUS TEST (K090964) | Binax, Inc. | 2009-12-16 |
| AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM (K093260) | International Biomedical, Ltd. | 2009-12-16 |
| LOUSEBUSTER (K093144) | Larada Sciences | 2009-12-16 |
| IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM (K091361) | Siemens Healthcare Diagnostics | 2009-12-16 |
| 44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM (K093549) | Biomet Manufacturing Corp | 2009-12-16 |
| ELECSYS PROBNP II CALCHECK 5 (K092169) | Roche Diagnostics | 2009-12-16 |
| CHIROPRO L SYSTEM (K092214) | Bien-Air Dental, SA | 2009-12-15 |
| MODIFICATION TO:CD HORIZON SPINAL SYSTEM (K092325) | Medtronic Sofamor Danek USA, Inc. | 2009-12-15 |
| ORTHOCOR KNEE SYSTEM BASIC (K091996) | Orthocor Medical | 2009-12-15 |
| LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION, PHYSIOLASER OLYMPIC, POLYLASER (K091675) | Reimers and Janssen GmbH | 2009-12-15 |
| ENDOFLIP (K092850) | Crospon, Ltd. | 2009-12-15 |
| TIGRT IVS (K092550) | Linatech, LLC | 2009-12-15 |
| CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR (K090931) | W&H Dentalwerk Buermoos GmbH | 2009-12-15 |
| LIFE SPINE STAND-ALONE SPACER SYSTEM (K091301) | Life Spine | 2009-12-15 |
| SPECTRA MEDICAL SAFETY SCAPEL (K091462) | Spectra, Inc. | 2009-12-15 |
| MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214 (K090785) | Invivo Corp. | 2009-12-15 |
| 3.25 SPLINE TWIST IMPLANT, HA COATED (K093164) | Zimmer Dental, Inc. | 2009-12-15 |
| STRAUMANN DENTAL ABUTMENTS (K092814) | Straumann Manufacturing, Inc. | 2009-12-15 |
| SMITH & NEPHEW TWINFIX ULTRA PK SUTURE ANCHOR (K093228) | Smith & Nephew, Inc. | 2009-12-15 |
| INTEGRA TOTAL WRIST FUSION SYSTEM (K093163) | Integra LifeSciences Corporation | 2009-12-15 |
| SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM (K093056) | Smith & Nephew, Inc. | 2009-12-15 |
| ENDO SMARTCAP (K093665) | Byrne Medical, Inc. | 2009-12-15 |
| CARIESCAN PRO (K090598) | Cariescan , Ltd. | 2009-12-15 |
| EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE (K093583) | St Jude Medical | 2009-12-15 |
| EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS (K092548) | Extremity Medical, LLC | 2009-12-15 |
| BD GENEOHM MRSA ACP ASSAY (K093346) | Bd Diagnostics (Geneohm Sciences, Inc.) | 2009-12-15 |
| ARIA RADIATION ONCOLOGY WITH MIRS (K093527) | Varian Medical Systems, Inc. | 2009-12-15 |
| ELI 350 ELECTROCARDIOGRAPH (K092663) | Mortara Instrument, Inc. | 2009-12-14 |
| SPOTCHECK BLOOD SPOT CONTROL, ASSAYED (K090940) | Astoria-Pacific, Inc. | 2009-12-14 |
| LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913 (K093498) | DiaSorin, Inc. | 2009-12-14 |
| COOLTOUCH VARIA ND:YAG LASER SYSTEM (K092964) | New Star Lasers, Inc. | 2009-12-11 |
| PIEZOTOME 2 (K091331) | Satelec | 2009-12-11 |
| XTAG CF60 KIT V2 (K083845) | Luminex Molecular Diagnostics, Inc. | 2009-12-11 |
| GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS (K092682) | Gyrus Acmi, Inc. | 2009-12-11 |
| SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES (K091233) | Synthes (Usa) | 2009-12-11 |
| AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION (K093672) | Sentinelle Medical, Inc. | 2009-12-11 |
| BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203 (K092505) | Beckman Coulter, Inc. | 2009-12-11 |
| DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4 (K091364) | Oehm Und Rehbein GmbH | 2009-12-11 |
| DIGITAL LIGHTBOX (K093117) | Brainlab AG | 2009-12-11 |
| ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE (K092943) | Arnold Tuber Industries | 2009-12-11 |
| NEUTRASAL (K093642) | Invado Pharmaceuticals | 2009-12-11 |
| INSIGHT ULTRASONIC INSERTS (K092417) | Discus Dental, LLC | 2009-12-11 |
| MODIFICATION TO MAMMAPRINT (K081092) | Agendia | 2009-12-11 |
| GAMMALOC SYSTEM, MODEL 03-00001 (K082588) | Dilon Technologies, LLC | 2009-12-11 |
| ACCUMAX (K093691) | Boston Scientific Corp | 2009-12-11 |
| LENSX 550 LASER SYSTEM (K092647) | Lensx Lasers, Inc. | 2009-12-11 |
| S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023 (K091711) | Alfa Wassermann Diagnostic Technologies, Inc. | 2009-12-11 |
| DISCOVERY MODEL NM/CT 670 (K093514) | Ge Medical Systems F.I. Haifa | 2009-12-10 |
| ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE (K093525) | Ventlab Corp. | 2009-12-10 |
| TERUMO PRESSURE ISOLATOR (K092644) | Terumo Cardiovascular Systems Corp. | 2009-12-10 |
| EAGLE EYE PLATINUM DIGITAL IVUS CATHETER (K092596) | Volcano Corporation | 2009-12-10 |
| NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4251, TD-4252, TD-4253 AND TD-4254 (K092099) | Taidoc Technology Corporation | 2009-12-10 |
| AFGHAN EXTERNAL FIXATOR (K092002) | Smith & Nephew, Inc. | 2009-12-10 |
| HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103 (K092807) | Augustine Biomedical & Design, LLC | 2009-12-10 |
| SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM (K093714) | Medison Co., Ltd. | 2009-12-10 |
| OSTEOTAPE (K090794) | Impladent , Ltd. | 2009-12-10 |
| NEONATAL ECG ELECTRODE, M203KEN (K092744) | R & D Medical Products, Inc. | 2009-12-10 |
| MODIFICATION TO LANX SPINAL FIXATION SYSTEM (K093285) | Lanx, LLC | 2009-12-10 |
| PRESIDIO PACS (K092125) | Reaonix Security, LLC | 2009-12-10 |
| SILVERSTREAM AND DERMASEPT (K093227) | Enzysurge , Ltd. | 2009-12-10 |
| EIDOSMED, MODEL EDG4.0 (K091992) | Eidosmed, LLC | 2009-12-09 |
| DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL IV-02XXXX (WHERE X IS ANY NUMBER BETWEEN 0-9) (K093332) | Delphi Medical Systems | 2009-12-09 |
| WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES (K092914) | Medshape Solutions | 2009-12-09 |
| ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003 (K091884) | Ark Diagnostics, Inc. | 2009-12-09 |
| ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA (K093750) | Ev3, Inc. | 2009-12-09 |
| CROSSCATH SUPPORT CATHTER (K093052) | Cook, Inc. | 2009-12-08 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K092966) | Jin Zhou Chang Hao Plastic Products Co., Ltd. | 2009-12-08 |
| KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM (K093312) | Kimberly-Clark Corp. | 2009-12-08 |
| ARROWBONE-A, ARROWBONE-B (K083372) | Brainbase Corporation | 2009-12-08 |
| BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160 (K092032) | Davol Inc., Sub. C. R. Bard, Inc. | 2009-12-08 |
| SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS (K090686) | Sic Brevetti S.R.L. | 2009-12-08 |
| BOLLARD MINIPLATE SKELETAL ANCHORAGE SYSTEM (K091051) | Tita-Link | 2009-12-08 |
| SD CHECK GOLD (K082683) | Standard Diagnostics, Inc. | 2009-12-08 |
| NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP) (K083371) | Natus Medical, Inc. | 2009-12-08 |
| NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM (K091457) | Nexstim OY | 2009-12-08 |
| E-PULSE (K091875) | Medevice Corporation | 2009-12-07 |
| WITTMANN PATCH (K093166) | Aperta, LLC | 2009-12-07 |
| HYLATOPIC PLUS EMOLLIENT FOAM (K093051) | Collegium Pharmaceutical Incorporated | 2009-12-07 |
| DS-A BLOOD GLUCOSE MONITORING SYSTEM (K082965) | Alliance International Co., Ltd. | 2009-12-07 |
| MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411 (K092793) | Bio-Medical Research, Ltd. | 2009-12-07 |
| QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C (K093522) | Maquet Cardiopulmonary, AG | 2009-12-07 |
| LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING (K091198) | Allied Hill Enterprises, Ltd. | 2009-12-07 |