| MORPHEUS OX (K111314) | Widemed, Ltd. | 2011-08-31 |
| STEERABLE GUIDE CATHETER (K112239) | Abbott Vascular | 2011-08-31 |
| CAPSURE(R) PS SYSTEM (K111913) | Spine Wave, Inc. | 2011-08-31 |
| CMC CABLE FIX (K111032) | Instratek, Inc. | 2011-08-31 |
| TD-4239 BLOOD GLUCOSE MONITORING SYSTEM AND TD-4239 MULTI BLOOD GLUCOSE MONITORING SYSTEM (K101635) | Taidoc Technology Corporation | 2011-08-31 |
| MDRIVE (K111742) | Embla Systems | 2011-08-31 |
| ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS (K103747) | Elitechgroup Seppim S.A.S. | 2011-08-31 |
| DEPUY STTUNE (TM) PS KNEE SYSTEM (K111433) | DePuy Orthopaedics, Inc. | 2011-08-30 |
| FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE (K110289) | Xian Friendship Medical Electronics Co., Ltd. | 2011-08-30 |
| TSRH SPINAL SYSTEMS (K111942) | Medtronic Sofamor Danek USA, Inc. | 2011-08-30 |
| RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION (K110129) | Rightmedical Products, LLC | 2011-08-30 |
| MONICA IF24 (K112163) | Monica Healthcare | 2011-08-30 |
| TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200 (K101543) | Tyson Bioresearch, Inc. | 2011-08-30 |
| INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1 (K111236) | B.Braun Melsungen AG | 2011-08-30 |
| WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE (K111548) | Fujifilm Medical System U.S.A., Inc. | 2011-08-30 |
| ZYTO HAND CRADLE (K111308) | Zyto Technologies, Inc. | 2011-08-30 |
| PALINDROME RT CHRONIC CATHETER (K111817) | Covidien | 2011-08-30 |
| ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05 (K112029) | Elitechgroup | 2011-08-30 |
| SONO-SERIES CORNERSTONE TECHNIQUE (K111374) | PAJUNK GmbH Medizintechnologie | 2011-08-29 |
| NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL (K111572) | Serf | 2011-08-29 |
| ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEM (K112339) | Samsung Medison Co., Ltd. | 2011-08-29 |
| NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM (K110648) | Nova Biomedical Corporation | 2011-08-29 |
| MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS) (K111386) | Smiths Medical MD, Inc. | 2011-08-29 |
| BLUEPHASE STYLE (K110756) | Ivoclar Vivadent, Inc. | 2011-08-29 |
| SLIC SCREW REPAIR SYSTEM (K111608) | Acumed, LLC | 2011-08-29 |
| 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES (K111172) | Daavlin Distributing Co. | 2011-08-29 |
| INQU PASTE MIX PLUS (K103799) | Isto Technologies, Inc. | 2011-08-29 |
| AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE (K103308) | KARL STORZ Endoscopy-America, Inc. | 2011-08-29 |
| HARMONIE SYSTEM (K083577) | Stellate Systems | 2011-08-29 |
| MATRISTEM WOUND MATRIX (K112409) | Acell, Inc. | 2011-08-29 |
| VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020 (K091960) | Abbott Molecular, Inc. | 2011-08-29 |
| SNAP WOUND CARE SYSTEM (K112341) | Spiracur, Inc. | 2011-08-29 |
| ENDOWRIST ONE SUCTION/IRRIGATOR (K110451) | Intuitive Surgical, Inc. | 2011-08-26 |
| ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM (K103181) | Genoray Co., Ltd. | 2011-08-26 |
| EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER (K111535) | Exact Medical Manufacturing, Inc. | 2011-08-26 |
| COMFORTGLIDE INTERMITENT CATHETER (K112137) | C.R. Bard, Inc. | 2011-08-26 |
| COVAMAX RESORBABLE COLLAGEN MEMBRANE (K103087) | Biom'Up Sas | 2011-08-26 |
| WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL (K110269) | Well Lead Medical Co., Ltd. | 2011-08-26 |
| MONOBLOC BM SERIES (K111573) | Hass Corp. | 2011-08-26 |
| ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS (K102678) | Andon Medical Co., Ltd. | 2011-08-26 |
| AUTOREADER 2 (K103532) | Trek Diagnostic Systems | 2011-08-26 |
| INSTINCT JAVA SYSTEM (K111301) | Zimmer Spine | 2011-08-26 |
| ANGIOSCULPT PTA SCORING BALLOON CATHETER (K112182) | Angioscore, Inc. | 2011-08-26 |
| AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING (K112235) | Airstrip Technologies, LP | 2011-08-26 |
| ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY (K110934) | Siemens Healthcare Diagnostics | 2011-08-25 |
| VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY (K101234) | Ventana Medical Systems, Inc. | 2011-08-25 |
| AQUILION LB MOVEMENT BASE KIT (K111633) | Toshiba America Medical Systems, In.C | 2011-08-25 |
| YOULASER CO2 LASER SYSTEM (K111592) | Quanta System Spa | 2011-08-25 |
| XYLOS MACRO-POROUS SURGICAL MESH (K111584) | Xylos Corporation | 2011-08-25 |
| NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET (K111101) | Norfolk Medical | 2011-08-25 |
| SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS (K112112) | Sentinel Medical, Inc. | 2011-08-25 |
| ELECSYS N-MID OSTEOCALCIN CALCHECK 5 (K112104) | Roche Diagnostics | 2011-08-25 |
| SONICATOR PLUS 920 (K111482) | Mettler Electronics Corp. | 2011-08-25 |
| VESOFLOW (K110977) | Caremed Supply, Inc. | 2011-08-25 |
| DAYTONA ANTERIOR CERVICAL CAGE (K110733) | Spinenet, LLC | 2011-08-25 |
| GEMORE MUSCLE CONDITIONER; (K102926) | Gemore Technology Co, Ltd. | 2011-08-25 |
| CHESAPEAKE (CERVICAL COMPONENTS) (K111439) | K2m, Inc. | 2011-08-24 |
| PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES (K111528) | Pioneer Surgical Technology, Inc. | 2011-08-24 |
| LIFECARE CONDUCTIVE GARMENTS (K103719) | Everyway Medical Instruments Co.,Ltd | 2011-08-24 |
| MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVERY KIT (K102511) | C.R. Bard, Inc. | 2011-08-24 |
| DIGITAL THERMOMETER MT SERIES (K110776) | Sejoy Electronics & Instruments Co., Ltd. | 2011-08-24 |
| BIOGEL ORTHOPOR BROWN SURGICAL GLOVE (K112089) | Molnlycke Health Care Us, LLC | 2011-08-24 |
| ECG SERIES ELECTROCARDIOGRAPH (K111805) | Advanced Instrumentations, Inc. | 2011-08-24 |
| SHENGKUN CHEMICAL (K110621) | Zibo Shengkun Chemical Industrial Co., Ltd. | 2011-08-24 |
| NUVANT, MOBILE CARDIAC TELEMETRY (K111917) | Corventis, Inc. | 2011-08-24 |
| SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM (K111293) | Soundcure, Inc. | 2011-08-24 |
| HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM (K110031) | Instrumentation Laboratory CO | 2011-08-24 |
| THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR (K103706) | Applied Cardiac Systems, Inc. | 2011-08-24 |
| PERIMETER INTERBODY FUSION DEVICE (K111525) | Medtronic Sofamor Danek | 2011-08-24 |
| POWDER FREE NITRILE PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP A SKIN PROTECTANT DRUG (K111589) | Derma Care Plus Products, LLC | 2011-08-23 |
| PASS ANTERIOR SPINAL SYSTEM (K102406) | Medicrea Technologies | 2011-08-23 |
| INTEGRA(TM) CUSA NXT(TM) BONE TIPS (K111741) | Integra Burlington Ma, Inc. (Formerly Integra Radi | 2011-08-23 |
| STREAMLINE TL SPINAL SYSTEM (K111502) | Pioneer Surgical Technology, Inc. | 2011-08-23 |
| CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (K111507) | Centers for Disease Control and Prevention | 2011-08-23 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) (K110016) | Rongyao Plastic Produce Co., Ltd. | 2011-08-23 |
| BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL (K111072) | Bio-Rad Laboratories | 2011-08-23 |
| DEKA TAC DEVICE (K093915) | Deka Research & Development Corp. | 2011-08-23 |
| CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE (K111373) | Circle Cardiovascular Imaging, Inc. | 2011-08-23 |
| SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS (K111620) | Skeletal Dynamics, LLC | 2011-08-23 |
| DDRELEMENT (K110828) | Swissray Medical AG | 2011-08-23 |
| RESPIRE BLUE SERIES (K111207) | Respire Medical | 2011-08-23 |
| RELIEVA SOLO ELITE SINUS BALLOON CATHETER (K111254) | Acclarent, Inc. | 2011-08-22 |
| YOLO CURVE (K110342) | Yolo Medical, Inc. | 2011-08-22 |
| ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE (K110584) | Asahi Intecc Co., Ltd. | 2011-08-22 |
| BOSTON BAND (K111609) | Boston Brace Intl., Inc. | 2011-08-22 |
| TALON DISTALFIX PROXIMAL FEMORAL NAIL (K111352) | Orthopedic Designs North America, Inc. | 2011-08-22 |
| PROFEMUR(R) E CEMENTLESS HIP STEM (K111698) | Wrightmedicaltechnologyinc | 2011-08-19 |
| INFOSEND GSM (K110316) | Fisher & Paykel Healthcare, Ltd. | 2011-08-19 |
| SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM) (K111550) | Sonoma Orthopedic Products, Inc. | 2011-08-19 |
| SILK'N FX (K110301) | Home Skinovations , Ltd. | 2011-08-19 |
| ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033 (K111952) | Beckman Coulter, Inc. | 2011-08-19 |
| TRIMED RADIOCARPAL FUSION SYSTEM (K102785) | TriMed, Inc. | 2011-08-19 |
| POLARIS SPINAL SYSTEM (K111957) | Biomet Spine (Ebi, LLC) | 2011-08-19 |
| STAXX XDL SYSTEM (K102315) | Spine Wave, Inc. | 2011-08-19 |
| POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE (K103734) | Central Medicare Sdn Bhd | 2011-08-19 |
| V200 INTELLI-TRAK OPTION (K110795) | Respironics California, Inc. | 2011-08-19 |
| CKMB UDR ASSAY (K102706) | SENTINEL CH. SpA | 2011-08-19 |
| TL-CERMIDE SKIN BARRIER EMULSION (K110757) | Trigen Laboratories, Inc. | 2011-08-19 |
| ARTHREX SCAPHOLUNATE ANCHOR (K111661) | Arthrex, Inc. | 2011-08-19 |
| INBODY (K110689) | Biospace Corporation Limited | 2011-08-19 |