| TRANSRADIAL ARTERY ACCESS DEVICES (K112554) | Teleflexmedical, Inc. | 2011-11-18 |
| SYNGO VIA MI WORKFLOWS (K113029) | Siemens Medical Solutions USA, Inc. | 2011-11-18 |
| VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX (K111983) | Zimmer Trabecular Metal Technology | 2011-11-18 |
| GUARDIAN INFLATABLE BONE EXPANDER SYSTEM (K111593) | Bm Korea Co., Ltd. | 2011-11-18 |
| ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS (K111960) | Elitechgroup | 2011-11-18 |
| OBC BONE ANCHORED HEARING SYSTEM (K112053) | Oticon Medical AB | 2011-11-18 |
| ONCO TRAC MODEL 1, 2, 4 (K111642) | Translational Sciences Corporation | 2011-11-18 |
| KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM (K112132) | Medicatech USA | 2011-11-18 |
| SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER (K112050) | Biosense Webster, Inc. | 2011-11-18 |
| VITREA CT MYOCARDIAL ANALYSIS (K112531) | Vital Images, Inc. | 2011-11-18 |
| PIEZO BONE SURGERY (K111290) | Guilin Woodpecker Medical Instrument Co., Ltd. | 2011-11-18 |
| DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS (K102833) | Foshan Nanhai Bai HE Medical Technology Co., Ltd. | 2011-11-18 |
| AVO BARRIER TOPICAL EMULSION (K110762) | Trigen Laboratories, Inc. | 2011-11-18 |
| AMBU ASCOPE 2 (K110962) | Ambu A/S | 2011-11-18 |
| ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL (K103376) | Seppim S.A.S. | 2011-11-18 |
| MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER (K110560) | Medtronic Neurosurgery | 2011-11-18 |
| SYNTHES USS (K111358) | Synthes Spine | 2011-11-18 |
| ONCENTRA PROSTATE 4.0 (K112420) | Nucletron | 2011-11-18 |
| FOUNDATION DENTAL RESIN (K111709) | Unix-Japan Co., Ltd. | 2011-11-18 |
| OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS (K112214) | St. Jude Medical Neuromodulation | 2011-11-17 |
| POWER FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR (K113191) | Suqian Ruijang Medical Supplies Co., Ltd. | 2011-11-17 |
| MEMOMETAL INTRA-MEDULLARY BONE FASTENER (K112197) | Memometal Technologies | 2011-11-17 |
| ACCELEDENT (K110661) | Orthoaccel Technologies, Inc. | 2011-11-17 |
| CLEARFIL DC CORE PLUS (K111982) | Kuraray America, Inc. | 2011-11-17 |
| INTELLIVUE MX40 PATIENT MONITOR (K113125) | Philips Medical Systems | 2011-11-17 |
| MOBCARDIO SYSTEM (K113234) | Mobhealth Incorporation | 2011-11-17 |
| HY-BOND RESIGLASS (K111855) | Shofu Dental Corp. | 2011-11-17 |
| DREAMBOND (K112118) | Bisco, Inc. | 2011-11-17 |
| SYNTHES LCP PEDIATRIC PLATE SYSTEMS (K112085) | Synthes (USA) Products, LLC | 2011-11-17 |
| CLEARWAY RX NB CATHETER (K113112) | Atrium Medical Corp. | 2011-11-17 |
| SNORERX 9.0 (K112205) | Consumer Health Products, Inc. | 2011-11-16 |
| TASMAN (K112393) | Resmed, Ltd. | 2011-11-16 |
| APOLLO (K111026) | Pollogen, Ltd. | 2011-11-16 |
| SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS (K111323) | Synthes, Inc. | 2011-11-16 |
| VIZION (K112276) | Trek Diagnostic Systems | 2011-11-16 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K113195) | Suqian Ruijang Medical Supplies Co., Ltd. | 2011-11-16 |
| HEALTHTRACKER (K110770) | Wistron Corporation | 2011-11-16 |
| MEDLINE PNEUMOPERITONEUM NEEDLE (K111955) | Medline Industries, Inc. | 2011-11-16 |
| CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY (K103818) | Ventana Medical Sytems, Inc. | 2011-11-16 |
| STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUM (K112280) | Straumann USA | 2011-11-16 |
| RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE (K111773) | Renu Medical, Inc. | 2011-11-16 |
| SOYALA SILKGEL FULL FACE MASK (K112167) | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2011-11-16 |
| THE BELMONT BUDDY LITE FLUID WARMER (K112639) | Belmont Instrument Corp. | 2011-11-16 |
| HYPERELASTIC WIRE (K112640) | Ormco Corp. | 2011-11-16 |
| DENTAL LASER THERAPY SYSTEM (K113212) | China Daheng Group, Inc. | 2011-11-16 |
| REPROCESSED HAND ACTIVATE SEALER/DIVIDER (K111600) | Ascent Healthcare Solutions | 2011-11-15 |
| SONOSITE EDGE ULTRASOUND SYSTEM (K113156) | Sonosite,Inc. | 2011-11-15 |
| STERISPINEPS PEDICLE SCREW (K112453) | Safe Orthopaedics | 2011-11-15 |
| RSP GLENOID BASEPLATE POROUS COATED (K112069) | Encore Medical L.P. | 2011-11-15 |
| ANATOMIC PEEK CERVICAL FUSION SYSTEM (K112444) | Medtronic Sofamor Danck USA, Inc. | 2011-11-15 |
| ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL (K111005) | Medica Corp. | 2011-11-15 |
| EMERGE FRACTIONAL LASER (K111840) | Palomar Medical Products, Inc. | 2011-11-14 |
| FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL (K102413) | Vilex, Inc. | 2011-11-14 |
| ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR (K112111) | Acumed, LLC | 2011-11-14 |
| IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT (K113279) | Kettenbach GmbH & Co. KG | 2011-11-14 |
| VARIAN HIGH ENERGY LINEAR ACCELERATOR (K112839) | Varian Medical Systems | 2011-11-14 |
| PERI-LOC PROXIMAL FEMUR LOCKING BONE PLATES (K112406) | Smith & Nephew, Inc. | 2011-11-14 |
| ARGES IMAGING CONTRAST SPRAY (K113263) | Arges Imaging, Inc. | 2011-11-14 |
| ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM (K111843) | Smith & Nephew Inc., Endoscopy Div. | 2011-11-14 |
| BMR FACE (K103031) | Bio-Medical Research, Ltd. | 2011-11-10 |
| KNOTLESS SUTURE FIXATION SYSTEM (K111716) | Core Essence Orthopaedics | 2011-11-10 |
| CHARTIS CONSOLE (K111764) | Pulmonx, Inc. | 2011-11-10 |
| NH-301 AMBULATORY ECG ANALYSIS SOFTWARE (K111487) | Norav Medical Corp. | 2011-11-10 |
| X-FORCE (K111557) | Seven Seas Distribtion and Manufacturing, LLC | 2011-11-10 |
| PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS) (K110463) | Norav Medical , Ltd. | 2011-11-10 |
| VESSEL GUARDIAN (K112357) | Lexion Medical, LLC | 2011-11-10 |
| MULTIFUNCTION KEITO (K103058) | Aguiflai Iberica S.L. | 2011-11-10 |
| NEXGEN EXPANDABLE CATHETER (K102925) | Nexgen Medical Systems, Inc. | 2011-11-10 |
| DIGITAL FLAT PANEL X-RAY DETECTOR (K112558) | Samsung Mobile Display Co., Ltd. | 2011-11-10 |
| CS 1200 (K112321) | Carestream Health, Inc. | 2011-11-10 |
| SPI VARIO ANGLED ABUTMENT (K111984) | Thommen Medical AG | 2011-11-10 |
| VASOPRESS REPROCESSED DVT LEG / FOOT GARMENTS (K112838) | Compression Therapy Concepts, Inc. | 2011-11-10 |
| XTRACT SYRINGE KEY SYSTEM (K112475) | Xtract Solutions | 2011-11-10 |
| CT-GUIDE NEEDLE GUIDANCE SYSTEM (K113063) | Activiews, Ltd. | 2011-11-10 |
| IGLUCOSE SYSTEM (K111932) | Positiveid Corporation | 2011-11-10 |
| AMEDITECH IMMUTEST MILTI-DRUG SCREEN (K113046) | Ameditech, Inc. | 2011-11-10 |
| PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER (K113019) | Wrightmedicaltechnologyinc | 2011-11-10 |
| TELAMON PEEK SPINAL SYSTEM (K110562) | Medtronic Sofamor Danek USA | 2011-11-09 |
| SWEETSPOT DIABETES DATA MANAGEMENT SERVICE (K111509) | Sweetspot Diabetes Care, Inc. | 2011-11-09 |
| T:SLIM (TM) INSULIN DELIVERY SYSTEM (K111210) | Tandem Diabetes Care, Inc. | 2011-11-09 |
| CERCON HT (K112152) | Dentsply International, Inc. | 2011-11-09 |
| SPIRO PD (K103575) | Pmd Healthcare | 2011-11-09 |
| RUBICON SUPPORT CATHETER (K112303) | Boston Scientific | 2011-11-09 |
| ASIMANAGER - AT (K111356) | Arlington Scientific, Inc. | 2011-11-09 |
| POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS PER DM SQUARED OR LESS OF WATER SOLUBLE (K112988) | Northstar Healthcare Holdings Limited | 2011-11-09 |
| CATHETER CONNECTIONS' DUALCAP DUO (K112985) | Catheter Connections, Inc. | 2011-11-09 |
| HUMELOCK CEMENTED SHOULDER PROSTHESIS (K111097) | Fx Solutions | 2011-11-09 |
| AXERA ACCESS SYSTEM (K113110) | Arstasis, Inc. | 2011-11-09 |
| CPK REAGENT (K112416) | Vital Diagnostics (Manufacturing) Ptyltd | 2011-11-09 |
| INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER (K112601) | Intricon Datrix Corporation | 2011-11-09 |
| ENSITE VELOCITY SYSTEM V.3.0 (K112688) | St Jude Medical | 2011-11-09 |
| POWERPRESS UNIT (K110276) | Hanuri Distribution, Inc. | 2011-11-09 |
| ASA 'MPHI FAMILY DIODE LASER (K111901) | Cynosure, Inc. | 2011-11-09 |
| PATIENT MONITOR (K112190) | Mediana Co., Ltd. | 2011-11-09 |
| STINGRAY ULTRALITE DISPOSABLE IRRIGATING BIPOLAR FORCEPS (K102752) | Stingray Surgical Products, Inc. | 2011-11-09 |
| FD TENS 2050 OR SLIDE TENS MODEL FD2050 (K111645) | Fuji Dynamics , Ltd. | 2011-11-09 |
| NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM (K110442) | Nanovis, LLC | 2011-11-09 |
| ENSEAL G2 TISSUS SEALERS (K112033) | Ethicon Endo-Sugery, LLC | 2011-11-08 |
| PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT (K103788) | HORIBA ABX SAS | 2011-11-08 |
| GRANDIO CORE DUAL CURE (K112447) | Voco GmbH | 2011-11-08 |