| ARAGON ONESHOT SYSTEM (K081312) | Aragon Surgical, Inc. | 2008-10-31 |
| MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002 (K083135) | Thermogear, Inc. | 2008-10-31 |
| PB 540 VENTILATOR (K082966) | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2008-10-31 |
| NEURON DELIVERY CATHETER 070 (K082290) | Penumbra, Inc. | 2008-10-31 |
| BP LIMBO XL, BPTANGO XL, BP SALSA XL (K072752) | Datadancer Medical Systems | 2008-10-31 |
| G2 EXPRESS FILTER SYSTEM - FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS (K082305) | C.R. Bard, Inc. | 2008-10-31 |
| SCANSCOPE XT SYSTEM (K080254) | Aperio Technologies | 2008-10-31 |
| TWINGUARD WITH CAPNOGRAPH ACCESSORY (K080527) | Trawax Pty Limited | 2008-10-31 |
| NEUROLINK IP, MODEL PK1113 (K081741) | Excel-Tech Ltd. (Xltek) | 2008-10-31 |
| APPLICATORS FOR AFTERLOADING BRACHYTHERAPY (K082530) | Isodose Control B.V. | 2008-10-30 |
| GRADIA CORE (K082171) | GC America, Inc. | 2008-10-30 |
| TEPHAFLEX ABSORBABLE SUTURE (K082178) | Tepha, Inc. | 2008-10-30 |
| UNITY BETA ANCHOR SYSTEM (K082906) | Bonutti Research, Inc. | 2008-10-30 |
| VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM) (K082667) | Visionsense, Ltd. | 2008-10-30 |
| AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5 (K082717) | Aalto Scientific, Ltd. | 2008-10-30 |
| THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751 (K082241) | Dale Medical Products, Inc. | 2008-10-30 |
| CHROMOPHARE E 778 AND E 558 (K083066) | Berchtold Holding GmbH | 2008-10-30 |
| HYDROLYZED COLLAGEN WITH 10% CHONDROITIN SULFATE (PSGAG, POLYSULFATED GLYCOSAMINOGLYCAN) WOUND GEL (K081724) | Applied Nutritionals | 2008-10-30 |
| DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306 (K081857) | Siemens Healthcare Diagnostics, Inc. | 2008-10-30 |
| PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1 (K082267) | Smith & Nephew, Inc. | 2008-10-29 |
| MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODELWATCHBP OFFICE (TWIN200). (K082357) | Microlife Intellectual Property GmbH | 2008-10-29 |
| PINNACLE ROII INTRODUCER SHEATH (K082847) | Terumo Medical Corp. | 2008-10-29 |
| DURASHIELD PLUS (K082198) | Dentsply Intl., Inc. | 2008-10-29 |
| FLOWMEDICA BENEPHIT INFUSION SYSTEMS (K082163) | Flowmedica, Inc. | 2008-10-29 |
| MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM (K073307) | Bio-Technology USA, Inc. | 2008-10-29 |
| APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR (K083021) | Sorin Group Italia S.R.L. | 2008-10-29 |
| OPTIFLUX F250NR, MODEL 0500325E (K082414) | Fresenius Medical Care North America | 2008-10-28 |
| P & F POWER WHEELCHAIR, MODEL HC-500SB (K082722) | P & F Brother Ind., Corp. | 2008-10-28 |
| PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA: CSF (K082183) | PAJUNK GmbH Medizintechnologie | 2008-10-28 |
| BRAVORACER PEDIATRIC MANUAL WHEELCHAIR (K082314) | Otto Bock Healthcare LP | 2008-10-28 |
| DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000 (K082798) | Medicatech USA | 2008-10-28 |
| MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE (K082595) | Roche Diagnostics | 2008-10-28 |
| KYMCO FORU, MODEL EQ20 (K082901) | Kwang Yang Motor Co., Ltd. | 2008-10-28 |
| LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS (K082721) | Photo Medex, Inc. | 2008-10-28 |
| VTI INTRAOPERATIVE DOPPLER SYSTEMS (K082870) | Vascular Technology Incorporated | 2008-10-28 |
| DEVILBISS DV5M SMARTLINK SYSTEM (K082209) | Sunrise Medical | 2008-10-28 |
| KYMCO FORU, MODEL EQ10 (K082900) | Kwang Yang Motor Co., Ltd. | 2008-10-28 |
| KING`YIELD WRIST BLOOD PRESSURE MONITOR, MODEL BP201 (K083043) | Shenzhen Kingyield Technology Co., Ltd. | 2008-10-27 |
| PRECISION OXYGEN CONCENTRATOR (K072348) | Precision Medical, Inc. | 2008-10-27 |
| MPOWRX SNORING SOLUTION (K081965) | Mpowrx Health and Wellness Products, Inc. | 2008-10-27 |
| 10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890 (K081733) | Boston Scientific Corp | 2008-10-27 |
| PROSTIVA RF THERAPY HAND PIECE, MODEL 8929 (K082464) | Medtronic, Inc. | 2008-10-27 |
| QUANTA LITE OMP PLUS ELISA (K081248) | Inova Diagnostics, Inc. | 2008-10-27 |
| PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA OF THE PERIPHERAL PLEXUS: SINGLE SHOT (K082164) | PAJUNK GmbH Medizintechnologie | 2008-10-27 |
| UC-CARE POSITIONING SYSTEM (K082919) | Uc-Care Medical Systems, Ltd. | 2008-10-27 |
| COOK WIRE GUIDES (K082536) | Cook Urological, Inc. | 2008-10-27 |
| MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF) (K080339) | Medsource International, LLC | 2008-10-27 |
| CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980 (K082263) | Biolitec, Inc. | 2008-10-24 |
| TEMPORARY TOOTH REPLACEMENT (K081900) | Ormco Corp. | 2008-10-24 |
| DISTAL RADIO-ULNAR JOINT IMPLANT (K082839) | Aptis Medical, LLC | 2008-10-24 |
| AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS (K082120) | Tornier | 2008-10-24 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K082597) | Tangshan Linyuan Plastic Products Co., Ltd. | 2008-10-24 |
| VANGUARD CR STEM HOUSINGS (K082826) | Biomet Manufacturing Corp | 2008-10-24 |
| EASY GLAZE (K082285) | Voco GmbH | 2008-10-24 |
| INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS (K081732) | Siemens Healthcare Diagnostics | 2008-10-24 |
| PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C (K082923) | Life-Tech, Inc. | 2008-10-24 |
| MULLINS-X, MODEL 250X (K082868) | NuMED, Inc. | 2008-10-24 |
| TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM (K081413) | Dailian Latex Company, Ltd. | 2008-10-24 |
| SENSITITRE VIZION (K081520) | Trek Diagnostic Systems, Inc. | 2008-10-24 |
| LEVO C3 (K083017) | Levo AG | 2008-10-24 |
| KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530 (K081587) | Krell Precision (Yang Zhou) Co., Ltd. | 2008-10-24 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM (K081543) | Ortho-Clinical Diagnostics, Inc. | 2008-10-23 |
| PROFILE MULTI-PLATFORM SYSTEM (K081352) | Sciton, Inc | 2008-10-23 |
| ABC SYRINGE INFUSION PUMP, MODEL 4100 (K072603) | Elixir Corporation | 2008-10-23 |
| K-PACK II NEEDLE - 29G THIN WALL (K082820) | Terumo Europe N.V. | 2008-10-23 |
| AERONEB GO NEBULIZER (K081650) | Aerogen (Ireland), Ltd. | 2008-10-23 |
| MODIFICATION TO ZENIEVA (K082865) | Gorbec Pharmaceutical Services, Inc. | 2008-10-23 |
| MEDICAL DISPLAY, MD205MG-1 (K082493) | Nec Display Solutions , Ltd. | 2008-10-23 |
| X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER (K080944) | C.R. Bard, Inc. | 2008-10-23 |
| EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700 (K082139) | Edwards Lifesciences, LLC | 2008-10-23 |
| BINAXNOW G6PD TEST (K080003) | Binax, Inc. | 2008-10-23 |
| LUMINEX INFRARED LAMP SYSTEM (K082969) | Medical Laser Systems, Inc. | 2008-10-23 |
| DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786 (K081382) | Duckworth & Kent, Ltd. | 2008-10-23 |
| FLASH N' GO (K082298) | Home Skinovations , Ltd. | 2008-10-23 |
| AMSELF CLOSED CATHETERIZATION SYSTEM (K082831) | Amsino International, Inc. | 2008-10-23 |
| RAYDOSE (K082221) | Raysearch Laboratories AB | 2008-10-22 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K082822) | Zibo Zhuangyuan Plastic Products Company | 2008-10-22 |
| OMRON MODEL HBP-2070 VITAL SIGNS MONITOR (K082812) | Omron Healthcare, Inc. | 2008-10-22 |
| ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM (K082513) | Lifescan, Inc. | 2008-10-22 |
| INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES (K081436) | Inviro Medical Devices, Inc. | 2008-10-22 |
| MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II (K082088) | Mako Surgical Corp. | 2008-10-22 |
| GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE (K083019) | Hospira, Inc. | 2008-10-22 |
| EVOLIS TOTAL KNEE SYSTEM (K081023) | Medacta International S.A. | 2008-10-22 |
| M5 DIAGNOSTIC ULTRASOUND SYSTEM (K083001) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008-10-22 |
| TENS/EMS COMBO, EMS, TENS (K082514) | Medihightec Medical Co., Ltd. | 2008-10-21 |
| GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 (K082417) | Arkray Factory USA, Inc. | 2008-10-21 |
| SHOWCASE (K082135) | Trillium Technology, Inc. | 2008-10-21 |
| E-Z CLEAN ELECTROSURGICAL ELECTRODE (K081791) | Megadyne Medical Products, Inc. | 2008-10-21 |
| STRAUMANN GUIDED INSTRUMENTS (K082532) | Straumann USA | 2008-10-21 |
| SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHETER KIT (K081404) | Spinal Integration, LLC | 2008-10-21 |
| ALCOHOL PAD (K080466) | 122 Corporation | 2008-10-21 |
| LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICE (K082774) | Lanx, LLC | 2008-10-21 |
| KOWA NONMYD ALPHA-DIII (K082767) | Kowa Co. , Ltd. | 2008-10-21 |
| XCHF-T160 VIDEOSCOPE (K082576) | Olympus Medical Systems Corporation | 2008-10-21 |
| SIMPLER MINI DENTAL IMPLANT: SM 3002 2.5 X 10MM, SM 3003 2.5 X 13MM, SM 3004 2.5 X 15MM (K073645) | 659543 BC , Ltd. | 2008-10-21 |
| NIPRO SAFETOUCH HUBER INFUSTION SET (K081210) | Nipro Medical Corp. | 2008-10-21 |
| ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE (K082095) | Smith & Nephew Endoscopy, Inc. | 2008-10-21 |
| G-BOND PLUS (K082768) | GC America, Inc. | 2008-10-21 |
| 1ML UNITRACT INSULIN SYRINGE 27G*1/2 , 1ML UNITRACT SYRINGE 29G*1/2 (K080877) | Unilife Medical Solutions Limited | 2008-10-21 |
| Y-ADAPTER (K082174) | Asthmatx, Inc. | 2008-10-20 |