| ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES (K093300) | Cardinal Health, Inc. | 2009-10-30 |
| SMARTPILL GI MONITORING SYSTEM, VERSION 2.0 (K092342) | The Smartpill Corporation | 2009-10-30 |
| F.A.S.T. SYSTEM SED AND CXD (K092623) | Genesis Medical Interventional, Inc. | 2009-10-30 |
| TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT (K091761) | Teleflexmedical, Inc. | 2009-10-29 |
| INNOVANCE D-DIMER, MODEL OPBP09 (K091916) | Siemens Healthcare Diagnostics | 2009-10-29 |
| QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000 (K090689) | Maquet Cardiopulmonary, AG | 2009-10-29 |
| PTFE PEELABLE INTRODUCER (K093023) | Great Batch Medical | 2009-10-29 |
| OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM (K093251) | Omniguide, Inc. | 2009-10-29 |
| EXELO2, MODEL 4010 (K090639) | Quantel Derma GmbH | 2009-10-29 |
| REEF HP 0.035 OTW PTA BALLOON DILATATION CATHETER (K092361) | Invatec S.P.A. | 2009-10-29 |
| IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM (K083080) | Sqi Diagnostics Systems | 2009-10-29 |
| MONOLISA ANTI-HAV EIA (K092355) | Bio-Rad Laboratories, Inc. | 2009-10-29 |
| ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508 (K091290) | Ethicon Endo-Surgery, Inc. | 2009-10-29 |
| MONOLISA ANTI-HAV IGM EIA (K092353) | Bio-Rad Laboratories, Inc. | 2009-10-29 |
| CHECKPOINT (K092292) | Ndi Medical, LLC | 2009-10-28 |
| IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 (K091984) | Siemens Medical Solutions Diagnostics | 2009-10-28 |
| GIVEN ELECTROSURGICAL NEEDLE (K082584) | Tripps Court Enterprises, Inc. | 2009-10-28 |
| AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610 (K093002) | MicroVention, Inc. | 2009-10-28 |
| ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS (K091566) | Zimmer GmbH | 2009-10-28 |
| VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA (K091284) | Affinity Biologicals, Inc. | 2009-10-28 |
| NEXUS XPULSE 805 IR LAMP SYSTEM, NEXUS XPULSE 980 IR LAMP SYSTEM, MODEL 805, 980 (K091726) | Usa Laser Biotech, Inc. | 2009-10-28 |
| ACELL MATRISTEM WOUND SHEET (K092926) | Acell, Inc. | 2009-10-28 |
| R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL (K091433) | R&D Systems, Inc. | 2009-10-28 |
| NORM SPINAL SYSTEM (K092011) | Norm Tibbi Urunler Ithalat Ihracat Sanayi VE Ticar | 2009-10-28 |
| ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100 (K092245) | Honsun (Nantong) Co., Ltd. | 2009-10-28 |
| NAVILAS LASER SYSTEM (K091064) | Od-Os GmbH | 2009-10-27 |
| ANKLE ARTHRODESIS PLATE SYSTEM (K090139) | Tornier, Inc. | 2009-10-27 |
| REVERSE SHOULDER PROSTHESIS (K092873) | Djo Surgical | 2009-10-27 |
| FLUID ISOLATION DEVICE (K091915) | Lenstec, Inc. | 2009-10-27 |
| MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE (K091446) | Palomar Medical Products, Inc. | 2009-10-27 |
| IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT AND ANCHOR, AKRFX INSTRUMENTATION (K092381) | Ibalance Medical, Inc. | 2009-10-27 |
| LOW & HIGH SPEED KIT (K090055) | Dpm USA Corp. | 2009-10-27 |
| MERIT LAUREATE HYDROPHILIC GUIDE WIRE (K092303) | Merit Medical Systems, Inc. | 2009-10-27 |
| COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT (K092150) | Biomet, Inc. | 2009-10-27 |
| ACACIA PISTON SYRINGE (K092986) | Acacia, Inc. | 2009-10-27 |
| CLEARFIL MAJESTY POSTERIOR PLT (K092281) | Kuraray Medical, Inc. | 2009-10-27 |
| GRS GLENOID RESURFACING SYSTEM (K091196) | Arthrosurface, Inc. | 2009-10-27 |
| VERIFY V-PRO CHEMICAL INDICATOR, VERSION 1A: VERIFY V-PRO CHEMICAL INDICATOR; VERSION 2A: ADHESIVE LABEL (K091174) | STERIS Corporation | 2009-10-27 |
| TSRH SPINAL SYSTEM (K093058) | Medtronic Sofamor Danek, Inc. | 2009-10-26 |
| KNEEKG (K091000) | Emovi | 2009-10-26 |
| S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG) (K091413) | Alfa Wassermann, Inc. | 2009-10-26 |
| SAVI WIRELESS, MODEL PM500 (K091696) | Medicomp, Inc. | 2009-10-26 |
| INSTRUMED VASCULAR CLAMPS (K092544) | Instrumed International, Inc. | 2009-10-26 |
| ULC SPINAL PEDICLE SCREW SYSTEM (K083077) | Otis Biotech Co., Ltd. | 2009-10-26 |
| MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BS1-3C (K092456) | Microlife Intellectual Property GmbH | 2009-10-23 |
| ALPHAMED SURGICAL SPEAR, MODEL 70-5000 (K091240) | Alphamed, Inc. | 2009-10-23 |
| BIS QUATRO SENSOR (K093183) | Aspect Medical Systems, Inc. | 2009-10-23 |
| ENTRACARE GASTROSTOMY FEEDING TUBE (K092418) | Entracare, LLC | 2009-10-23 |
| CLEARPATH (K091305) | Easyglide , Ltd. | 2009-10-23 |
| CURIOS (K090641) | Progentix Orthobiology BV | 2009-10-23 |
| AMD 6605 TENS/NMES (K092990) | Advantageous Medical Devices, LLC | 2009-10-23 |
| ORTHOCAD IQ (K082207) | Cadent, Inc. | 2009-10-23 |
| INTERFACE ACETABULAR CUP LINERS (K092443) | Omni Life Science, Inc. | 2009-10-23 |
| DK50 DS (K091871) | Ekom S.R.O. | 2009-10-23 |
| TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT (K090897) | Howmedica Osteonics Corp. | 2009-10-23 |
| MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM (K091100) | Interlace Medical, Inc. | 2009-10-23 |
| SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900 (K090542) | Sun-Rain System Corp. | 2009-10-23 |
| GAS TRANSFILL (K091191) | Respironics Inc., Sleep & Home Respiratory Group | 2009-10-23 |
| JAZZY FRONTIE (K092961) | Pride Mobility Products Corp. | 2009-10-23 |
| LIPIVIEW OCULAR SURFACE INTERFEROMETER (K091935) | Tearscience, Inc. | 2009-10-23 |
| VERTAPLEX HV (SINGLE PACK AND DUAL PACK) (K091606) | Stryker Corp. | 2009-10-23 |
| COMET ANTERIOR CERVICAL PLATE SYSTEM (K090751) | Apollo Spine, Inc. | 2009-10-23 |
| ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS (K091102) | Arkray Factory USA, Inc. | 2009-10-23 |
| MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025 (K092919) | Siemens Healthcare Diagnostics | 2009-10-23 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (YELLOW, WHITE, BLUE, PINK) (K092301) | Bettercare Plastic Products Co., Ltd. | 2009-10-22 |
| THERAFORM BILAYER (K090823) | Sewon Cellontech Co., Ltd. | 2009-10-22 |
| DEBP (K092783) | Enko , Ltd. | 2009-10-22 |
| PC ECG, MODEL SE-1010 (K092010) | Edan Instruments, Inc. | 2009-10-22 |
| EQUALSHIELD LUER LOCK CONNECTOR PAIR (K091389) | Plastmed, Ltd. | 2009-10-22 |
| MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) (K091499) | Kensey Nash Corp. | 2009-10-22 |
| ZIROX (K092630) | Zencera, Inc. | 2009-10-22 |
| LARGE FACE ANEROID SPHYGMOMANOMETER, WALL MODEL, DESK MODEL, MOBILE STAND MODEL, MODEL 41XX, 42XX, 43XX (K092604) | Trimline Medical Products Corp. | 2009-10-21 |
| VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST (K092957) | Nanosphere, Inc. | 2009-10-21 |
| ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045 (K092616) | CAO Group, Inc. | 2009-10-21 |
| POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O (K092492) | Wear Safe (Malaysia) Sdn. Bhd. | 2009-10-21 |
| REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10 (K092425) | Ascent Healthcare Solutions | 2009-10-21 |
| NEUROCALM MODEL 1 AND 2 (K090866) | Neuromed Devices, Inc. | 2009-10-21 |
| POWDER FREE EXAMINATION GLOVE (K092296) | Bettercare Plastic Products Co., Ltd. | 2009-10-21 |
| VINYL CO-POLMER FREE EXAMINATION GLOVES, BLUE COLOR (K092294) | Bettercare Plastic Products Co., Ltd. | 2009-10-21 |
| RAVEN PROTEST - STEAM BIOLOGICAL INDICATOR (K082756) | Raven Biological Laboratories, Inc. | 2009-10-21 |
| VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DH (K091414) | Biocare Corp. | 2009-10-21 |
| PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) (K092411) | Shen Wei (Usa), Inc. | 2009-10-21 |
| N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695 (K092824) | Alpha Protech, Inc. | 2009-10-21 |
| REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES (K092101) | Nonin Medical, Inc. | 2009-10-21 |
| EASYPLUS MINI MASTERDRIVER SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS09009 (K092887) | Eps Bio Technology Corp. | 2009-10-21 |
| ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING (K091354) | Acrymed, Inc. | 2009-10-21 |
| MODIFICATION TO: RAMP INFLUENZA A/B ASSAY (K093116) | Response Biomedical Corp. | 2009-10-21 |
| D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT (K092882) | Diagnostic Hybrids, Inc. | 2009-10-21 |
| DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG (K092283) | Siemens Healthcare Diagnostics | 2009-10-21 |
| COLONIC SPLINTING OVERTUBE, MODEL 00711145 (K092221) | United States Endoscopy Group, Inc. | 2009-10-20 |
| OMNI 2 OXYGEN SYSTEM (K083163) | Sequal Technologies, Inc. | 2009-10-20 |
| POLY-CHEM 90 GLUCOSE (K090703) | Polymedco, Inc. | 2009-10-20 |
| EMS AIR-FLOW HANDY PERIO (K092289) | E.M.S Electro Medical Systems S.A | 2009-10-20 |
| REJUVENATE MODULAR STEM (K092561) | Howmedica Osteonics Corp. | 2009-10-20 |
| LENSTAR, MODEL LS900 (K082891) | Haag-Streit AG | 2009-10-20 |
| ALCON ULTRACHOPPER (K091777) | Alcon Research, Ltd. | 2009-10-20 |
| ESTECH EASYFLOW CANNULA WITH GUIDEWIRE (K091542) | Endoscopic Technologies, Inc. D/B/A Estech | 2009-10-20 |
| ORTHOREX INTRA-OPERATIVE LOAD SENSOR (K090474) | Orthosensor, Inc. | 2009-10-19 |
| DISTRACTABLE WAVE CAGE (K083626) | Advanced Medical Technology, Inc. | 2009-10-19 |
| CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES (K092898) | Conmed Linvatec | 2009-10-19 |