| FILMARRAY RESPIRATORY PANEL (RP) (K103175) | Idaho Technology, Inc. | 2011-02-17 |
| NEXUS BIOWAVE 7W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 10W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 30W PRO IR LAMP SYSTEM, NEXUS (K101893) | Usa Laser Biotech, Inc. | 2011-02-17 |
| STIMTRODE SINGLE USE NERVE STIMULATOR (K110118) | Xavant Technology (Pty), Ltd. | 2011-02-17 |
| CLARITY ADVANCED CERAMIC BRACKETS (K102803) | 3M Unitek Corporation | 2011-02-17 |
| FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR (K101510) | Endymed Medical, Ltd. | 2011-02-17 |
| ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM (K110207) | Aloka Co., Ltd. | 2011-02-17 |
| CONMED R SABRE GENESIS TM ELECTROSURGICAL UNIT; CONED R SABRE GENESIS TM ELECTROSURGICAL UNIT (230V); CONMED HYFRESURG O (K103665) | Conmed Corporation | 2011-02-16 |
| ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE (K110183) | Arthrocare Corp. | 2011-02-16 |
| GDC 360 DETEACHABLE COIL (K103355) | Boston Scientific Corp | 2011-02-16 |
| ZENOSTAR MAGIC GLAZE (K103494) | Wieland Dental + Technik GmbH & Co. KG | 2011-02-16 |
| CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM (K103678) | Ge Medical Systems Information Technologies GmbH | 2011-02-16 |
| ENZYME II CALIBRATOR (K103836) | Siemens Healthcare Diagnostics, Inc. | 2011-02-16 |
| DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES (K103321) | Dana Products, Inc. | 2011-02-16 |
| DYNAREX ULTRASOUND GEL (K102637) | Dynarex Corporation | 2011-02-16 |
| FINESS ENDOSCOPE (K102366) | Entellus Medical, Inc. | 2011-02-15 |
| SYSTEMS INTEGRATION (K102763) | Olympus Medical Systems Corporation | 2011-02-15 |
| AXSOS LOCKED PLATING 4.0MM LOCKING INSERTS (K110176) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2011-02-15 |
| AFINION ANALYZER (K110056) | Axis-Shield Poc AS | 2011-02-15 |
| ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR (K102762) | Orthocon, Inc. | 2011-02-15 |
| FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM (K103838) | Precision Surgery , Ltd. | 2011-02-15 |
| SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER (K103753) | Sirona Dental Systems GmbH | 2011-02-15 |
| VANTAGE ABI (K103693) | Summit Doppler Systems, Inc. | 2011-02-15 |
| ATRIUM CENTRILFX MESH (K110110) | Atrium Medical Corporation | 2011-02-15 |
| PHILIPS ECG LEADWIRE SET (K110287) | Philips Medical Systems | 2011-02-15 |
| ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012 (K102109) | Eurosets S.R.L | 2011-02-15 |
| PSL ANTERIOR CERVICAL PLATE SYSTEM (K103819) | Precision Surgery , Ltd. | 2011-02-15 |
| SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE (K091207) | Surgicraft , Ltd. | 2011-02-15 |
| TRABECULAR METAL FEMORAL CONE AUGMENTS (K103517) | Zimmer Trabecular Metal Technology, Inc. | 2011-02-15 |
| QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION (K103244) | Dentsply Intl., Inc. | 2011-02-14 |
| NEODENT GRAFT SCREW (K103084) | Jjgc Industria E Comercio DE Materiais Dentarios S | 2011-02-14 |
| TELIO CS INLAY & TELIO CS ONLAY (K103379) | Ivoclar Vivadent, Inc. | 2011-02-14 |
| DIMENSION VISA HBA1C, MODEL K3105A (K102045) | Siemens Heatlhcare Diagnostics, Inc. | 2011-02-14 |
| SKYLINE ANTERIOR CERVICAL PLATE SYSTEM (K103491) | A Johnson & Johnson Company | 2011-02-14 |
| FUSTAR STEERABLE INTRODUCERS (K100184) | Lifetech Scientific (Shenzhen) Co., Ltd. | 2011-02-14 |
| VISUALIZE: VASCULAR (K103761) | The Medipattern Corporation | 2011-02-11 |
| AS3700 ANESTHSIA DELIVERY SYSTEM (K102471) | Mindray DS USA, Inc. | 2011-02-11 |
| MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS (K103386) | Medtronic, Inc. | 2011-02-11 |
| 1.5T OPTIMA MR430S (K103238) | Ge Medical Systems, LLC | 2011-02-11 |
| ELECSYS ANTI-TPO CALSET (K103171) | Roche Diagnostics | 2011-02-11 |
| DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY (K103346) | Sherpa Korea | 2011-02-11 |
| VERSAFITCUP CC TRIO (K103352) | Medacta International | 2011-02-11 |
| ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A (K093867) | Roche Diagnostics | 2011-02-11 |
| O2-IN-A-BOX, O2-IN-A-BOX (K102750) | Geto2, Inc. | 2011-02-11 |
| DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP (K102321) | Samsung Mobile Display Co., Ltd. | 2011-02-11 |
| COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL (K102714) | Boston Scientific Corp | 2011-02-11 |
| BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) (K103345) | Breathe Technologies, Inc. | 2011-02-11 |
| SYSLOC MINI V3 (K110157) | JMS North America Corporation | 2011-02-11 |
| BRIVO MR355, OPTIMA MR360 (K103330) | Ge Hangwei Medical Systems Co., Ltd. | 2011-02-11 |
| NC TREK RX CORONARY DILATATION CATHETER (K110134) | Abbott Vascular-Cardiac Therapies | 2011-02-11 |
| SUPERDIMENSION MARKER DELIVERY KIT (K110093) | Superdimension, Inc. | 2011-02-11 |
| EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER (K110103) | Edwards Lifesciences, LLC | 2011-02-11 |
| BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM (K102449) | Bright Spine, Inc. | 2011-02-11 |
| THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS (K100144) | Microgenics Corp. | 2011-02-11 |
| SMART READ BIOLOGICAL TEST PACK (K103000) | Steritec Products Mfg Co, Inc. | 2011-02-11 |
| 4CIS VANE SPINE SYSTEM (K101818) | Solco Biomedical Co., Ltd. | 2011-02-11 |
| ROCHE ORAL FLUID COCAINE (K101160) | Roche Diagnostics | 2011-02-11 |
| ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM (K093745) | Lifescan, Inc. | 2011-02-11 |
| ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT (K092202) | Eswallow USA | 2011-02-10 |
| ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM (K102283) | Zeus Scientific, Inc. | 2011-02-10 |
| REUSABLE LINEAR STAPLER HANDLE (K110049) | Ethicon Endo-Surgery, LLC | 2011-02-10 |
| VENOFER PUMP (K103564) | Renal Solutions, Inc. | 2011-02-10 |
| SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311 (K101270) | Excelsior Medical Corp. | 2011-02-10 |
| PSORIA-LIGHT (K103540) | Psoria-Shield, Inc. | 2011-02-10 |
| LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION (K103553) | Bionostics, Inc. | 2011-02-10 |
| SPPHINE PLUS STM 3W DIODE LASER (K110079) | Den-Mat Holdings, LLC | 2011-02-10 |
| MASTERSCREEN IOS (K101873) | Carefusion Germany 234 GmbH | 2011-02-10 |
| COLONRING (K093661) | Niti Surgical Solutions, Ltd. | 2011-02-10 |
| LANX FUSION SYSTEM (K102738) | Lanx, LLC | 2011-02-10 |
| VENUS ANTERIOR CERVICAL PLATE (K103137) | Verticor, Ltd. | 2011-02-10 |
| HI-TORQUE BALANCE MIDDLEWEIGHT ELITE (K103101) | Abbott Vascular-Cardiac Therapies | 2011-02-10 |
| REDSENSE-ALARM UNIT AND SENSOR (K103242) | Redsense Medical AB | 2011-02-10 |
| CRYONIZE TM (K103310) | 3jt Enterprises, LLC | 2011-02-09 |
| FUSE PLIF CAFE (K100945) | Advanced Medical Technologies AG | 2011-02-09 |
| AAIO-7, AAIO WIRLESS (K110205) | Appasamy Associates | 2011-02-09 |
| VENUS BASIC SPINAL FIXATION SYSTEM (K103085) | L&K BIOMED Co., Ltd. | 2011-02-09 |
| NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM (K110010) | Blackrock Microsystems, Inc. | 2011-02-09 |
| VERIFY CHEMICAL MONITORING STRIP FOR RESERT SOULTIONS (RESERT XL TEST STRIP VERSION 2) (K102296) | STERIS Corporation | 2011-02-09 |
| HAMMERLOC TM TIBIAL FIXATION DEVICE (K103145) | Biomet Sports Medicine | 2011-02-09 |
| EXPLORER LIVER (PASSIVE TRACKING) (K101979) | Pathfinder Therapeutics, Inc. | 2011-02-09 |
| PULSE OXIMETER MODEL P10 (K100225) | Mediana Co., Ltd. | 2011-02-09 |
| I-STAT 1 WIRELESS ANALYZER (K103195) | Abbott Point of Care, Inc. | 2011-02-08 |
| SMITH & NEPHEW, INC SPATIALFRAME V4.1 WEB-BASED SOFTWARE (K110069) | Smith & Nephew, Inc. | 2011-02-08 |
| HEAL FORCE CO2 INCUBATOR (K101988) | Shanghai Lishen Scientific Equipment Co., Ltd. | 2011-02-08 |
| SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES (K103186) | Leonhard Lang GmbH | 2011-02-08 |
| MED-LOK SAFETY NEEDLE (K103781) | Sta-Med, LLC | 2011-02-08 |
| J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030 (K101902) | Jeil Medical Corporation | 2011-02-08 |
| INTEL HEALTH GUIDE (K103276) | Intel Corporation Digital Health Group | 2011-02-08 |
| TRILLIANT SURGICAL SUBTALAR IMPLANT (K103183) | Trilliant Surgical, Ltd. | 2011-02-08 |
| DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM (K110199) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2011-02-08 |
| VOLUSON E6/E8/E8 EXPERT DIAGNOSTIC ULTRASOUND SYSTEM MODEL: H48681BD/ H48681BX/ H48681BM (K101236) | GE Healthcare | 2011-02-08 |
| VISTA ENDOSCOPE,89 CM, 56CM , SCOUT BLUNT-TIPPED GUIDE- 106 CM, 86 CM, 53 CM, MODELS FG0027, FG0031, FG0029, FG 0028, (K100533) | Vibrynt, Inc. | 2011-02-08 |
| FLOWREST (K103316) | Vapotherm, Inc. | 2011-02-08 |
| LEUCADIA PEDICLE SCREW SYSTEM (K103102) | Phygen, LLC | 2011-02-08 |
| FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB (K110202) | Fujifilm Medical System U.S.A., Inc. | 2011-02-08 |
| MEDICAL VISORS MV100 (K103507) | Medical Visors, Inc. | 2011-02-08 |
| DEFIBRILLATOR ANALYZER - DA-2006P (K110192) | Bc Group International, Inc. | 2011-02-08 |
| LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) (K103040) | Lanx, LLC | 2011-02-08 |
| CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P (K101439) | Codonics, Inc. | 2011-02-07 |
| HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH (K101900) | Hakki Medical Technologies, Inc. | 2011-02-07 |
| STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER (K103158) | Angstrom Mfg., Inc. | 2011-02-07 |