| ROLL-X GUIDEWIRE (K082304) | St Jude Medical | 2008-08-27 |
| TAXI ENDOSCOPIC GUIDEWIRE (K081708) | Lake Region Mfg., Inc. | 2008-08-26 |
| TYSONBIO LINK HEALTH MANAGEMENT SYSTEM (K081726) | Tyson Bioresearch, Inc. | 2008-08-26 |
| VOLUMINA (K081215) | Kjaya Medical, LLC | 2008-08-26 |
| SKINSENSE POLYISOPRENE UNDERGLOVE (K081180) | Molnlycke Health Care Us, LLC | 2008-08-26 |
| ALLOMAP MOLECULAR EXPRESSION TESTING (DEN080007) | Xdx | 2008-08-26 |
| XIOS PLUS WALL-MODULE (K081903) | Sirona Dental Systems GmbH | 2008-08-26 |
| SMALL BONE LOCKING PLATING SYSTEM (K081546) | DePuy Orthopaedics, Inc. | 2008-08-26 |
| Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S (K082173) | Cardiac Science Corporation | 2008-08-26 |
| 2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S (K081511) | Smith & Nephew, Inc. | 2008-08-26 |
| STRYKER ESSX MICRODEBRIDER SYSTEM (K073633) | Stryker Ireland Ltd., Instruments Division | 2008-08-26 |
| MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT (K081516) | Medsource International, LLC | 2008-08-26 |
| ORTHO ALL-FLEX DIAPHRAGM (K080040) | Johnson & Johnson Produtos Profissionais Ltda. | 2008-08-25 |
| TM-400 (K081247) | Ito Co., Ltd. | 2008-08-25 |
| MICRO GUIDE CATHETER XP (K082143) | Cordis Corp. | 2008-08-25 |
| MODIFICATION TO HI-ART TREATMENT SYSTEM (K082005) | Tomotherapy Incorporated | 2008-08-25 |
| MESACUP MODELS BP180 AND BP230 ELISA KITS (K071961) | Mbl International Corporation | 2008-08-25 |
| CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT (K081237) | Craftmaster Contour Equipment, Inc. | 2008-08-25 |
| SONOSITE MAXX SERIES ULTRASOUND SYSTEM (K082098) | Sonosite,Inc. | 2008-08-25 |
| BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES (K080761) | Bonart Co., Ltd. | 2008-08-25 |
| PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC (K081558) | Pioneer Surgical Technology | 2008-08-25 |
| CENTRICITY PACS IW (K082318) | Ge Healthcare Dynamic Imaging Solutions | 2008-08-25 |
| DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES (K081468) | Sunrise Medical | 2008-08-25 |
| STERIS RESERT XL TEST STRIP (K081600) | STERIS Corporation | 2008-08-22 |
| M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00 (K081983) | Philips Medical Systems | 2008-08-22 |
| ELECSYS ANTI-TSHR CALCHECK (K080643) | Roche Diagnostics | 2008-08-22 |
| OHMNISCAN NG (K073334) | Christine Valmy, Inc. | 2008-08-22 |
| HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS (K082009) | Hsiner Co., Ltd. | 2008-08-22 |
| WESTAR SERIES DENTAL UNITS (K082294) | Westar Medical Products, Inc. | 2008-08-22 |
| RADVISION ET DIAGNOSTIC X-RAY SYSTEM (K082064) | Almana Medical Imaging | 2008-08-22 |
| PAINSHIELD MD (K081075) | Nano Vibronix , Ltd. | 2008-08-22 |
| PINNACLE PELVIC FLOOR REPAIR KIT II (K081048) | Boston Scientific Corp | 2008-08-22 |
| MSC LIPID CONTROL (K082067) | Maine Standards Co. | 2008-08-22 |
| CYGNUS 12 LEAD ECG MODULE (K072950) | Cygnus, LLC | 2008-08-22 |
| RHYTEC, INC., PORTRAIT PSR (K082197) | Rhytec Incorporated | 2008-08-22 |
| YSIO (K081722) | Siemens Medical Solutions USA, Inc. | 2008-08-22 |
| DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 (K082030) | Siemens Healthcare Diagnostics, Inc. | 2008-08-22 |
| VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905 (K082099) | Ortho-Clinical Diagnostics, Inc. | 2008-08-21 |
| XERACEM (K081405) | Doxa Dental AB | 2008-08-21 |
| PICASSO MASTER, ECT AND MASTER 3D (K081847) | E-Woo Technology | 2008-08-21 |
| ANYRAY PORTABLE X-RAY SYSTEM (K081899) | E-Woo Technology Co., Ltd. | 2008-08-21 |
| GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM (K081388) | Pronia Medical System, LLC | 2008-08-21 |
| SMITH & NEPHEW OXINIUM DH FEMORAL HEADS (K081566) | Smith & Nephew, Inc. | 2008-08-21 |
| ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW (K081393) | G & H Wire Co. | 2008-08-21 |
| PCA-8000A, MARK 11, PET / CT SYSTEM (K082244) | Toshiba America Medical Systems, In.C | 2008-08-21 |
| BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH (K081896) | Biogenics, Inc. | 2008-08-20 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW) (K081657) | Jiangsu Cureguard Glove Co., Ltd. | 2008-08-20 |
| GENTIAN CYSTATIN C IMMUNOASSAY (K081875) | Gentian AS | 2008-08-20 |
| TQ SOLO AND SOLO PRO AND LS50 ACCESSORY AND MR4 MULTI RADIANCE THERAPY SYSTEM (K080102) | Escada International, Inc. | 2008-08-20 |
| MEDILAS D FAMILY LASERS (K073427) | Dornier Medtech America, Inc. | 2008-08-20 |
| JMEA CANNULATED BONE SCREW SYSTEM (K080259) | Jmea Corporation | 2008-08-20 |
| REVELATION HIP STEM, MODELS, 427-01, 427-02; LINEAR HIP STEM, MODELS 425-00, 425-05 (K081679) | Encore Medical L.P. | 2008-08-20 |
| VIP PULMONARY FUNCTION SYSTEM (K080510) | Viasys Healthcare GmbH | 2008-08-20 |
| RX ACCUNET LP EMBOLIC PROTECTION SYSTEM (K081549) | Abbott Laboratories | 2008-08-19 |
| INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER (K082061) | Irvine Biomedical, Inc. | 2008-08-19 |
| AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ (K080872) | Amedica Biotech, Inc. | 2008-08-19 |
| CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080 (K082191) | Cardiomems, Inc. | 2008-08-19 |
| TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81 (K080641) | Home Diagnostics, Inc. | 2008-08-19 |
| HAIDA MODEL HD11 MANUAL WHEELCHAIR (K082274) | Jiangyin East China Medical Technology Co., Ltd. | 2008-08-19 |
| AXIUM DETACHABLE COIL SYSTEM (K081465) | Micro Therapeutics, Inc. | 2008-08-19 |
| HAIDA HD21 (K082288) | Jiangyin East China Medical Technology Co., Ltd. | 2008-08-19 |
| OVERSTITCH ENDOSCOPIC SUTURE SYSTEM (K081853) | Apollo Endosurgery, Inc. | 2008-08-18 |
| DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN (K073579) | Feg Textiltechnik Forschungs-Und Entwicklungsgesel | 2008-08-18 |
| REPROCESSED EXTERNAL FIXATION DEVICE (K081586) | Sterilmed, Inc. | 2008-08-18 |
| ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM (K072708) | Abbott Vascular-Vascular Solutions | 2008-08-18 |
| TRITON MEIDCAL TMED IV-SET (K073444) | Triton Medical, LLC | 2008-08-18 |
| SURGIMESH XB (K072974) | Aspide Medical | 2008-08-18 |
| AP 34 MULTI-THERAPY INFUSION PUMP (K082182) | Q-Core, Ltd. | 2008-08-15 |
| MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE (K080530) | Cutera, Inc. | 2008-08-15 |
| HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER (K082075) | Hansen Medical, Inc. | 2008-08-15 |
| TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXX (K080189) | Trimline Medical Products Corp. | 2008-08-15 |
| RESCUE EXTERNAL IMPLANT SYSTEM (K081302) | Megagen Implant Co., Ltd. | 2008-08-15 |
| HIPLOC COMPRESSION HIP SCREW (K080685) | Biomet Manufacturing, Inc. | 2008-08-15 |
| GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2 (K082185) | Ge Medical Systems Ultrasound and Primary Care Dia | 2008-08-15 |
| VERISTA IMAGING ISOCAM II GAMMA CAMERA (K081757) | Verista Imaging, Inc. | 2008-08-15 |
| C-INSIGHT (K081672) | Mazor Surgical Technologies , Ltd. | 2008-08-15 |
| MASS CASUALTY VENTILATOR, MODEL MCV100 (K080063) | Allied Healthcare Products, Inc. | 2008-08-15 |
| ANEROID SPHYGMOMANOMETER, MODEL KT-A01 (K081951) | Wenzhou Kindcare Import & Export Co., Ltd. | 2008-08-15 |
| INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105 (K080136) | Steritec Products, Inc. | 2008-08-15 |
| MODIFICATION TO MERCI RETRIEVER (K082034) | Concentric Medical, Inc. | 2008-08-15 |
| SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR (K081365) | St Jude Medical | 2008-08-15 |
| ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM (K081038) | Medtronic Sofamor Danek | 2008-08-15 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR (K081535) | Rich Mountain Medical Products, Inc. | 2008-08-14 |
| FLOWCARE TLG REAGENT (K081526) | Beckman Coulter, Inc. | 2008-08-14 |
| MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM (K081944) | Cardio Systems, Inc. | 2008-08-14 |
| WATCH-PAT 200S-2 (WP200S-2) (K081982) | Itamar Medical | 2008-08-14 |
| UNASSIGNED (K080544) | Medcomp | 2008-08-14 |
| BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 (K081213) | Bd Biosciences | 2008-08-14 |
| REPROCESSED EXTERNAL FIXATION ACCESSORIES (K081342) | Sterilmed, Inc. | 2008-08-13 |
| BODY-JET (K082025) | Human Med AG | 2008-08-13 |
| AVEA VENTILATOR (K081837) | Cardinal Health 207, Inc. | 2008-08-13 |
| SUNIVF DISHES (K080395) | <Genx> Intl., Inc. | 2008-08-13 |
| TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81 (K080710) | Home Diagnostics, Inc. | 2008-08-13 |
| MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION (K082175) | Bioplate, Inc. | 2008-08-13 |
| MAX ADJUSTING INSTRUMENT (K082218) | Manna Omni International, Inc. | 2008-08-13 |
| PARIETEX COMPOSITE MONO PM MESH (K081126) | Sofradim Production | 2008-08-13 |
| TRAUSON BONE PLATE (K073432) | Trauson (Jiangsu) Medical Instrument Co., Ltd. | 2008-08-13 |
| CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM (K081459) | Integra Radionics, Inc. | 2008-08-13 |
| SOLEX CATHETER, MODEL SL2593 (K081936) | Alsius Corp. | 2008-08-13 |
| SERIES SY DISPOSABLE ELECTROSURGICAL PAD (K082204) | Ventlab Corp. | 2008-08-13 |