| POWDER FREE NITRILE EXAMINATION GLOVES (K111328) | Gx Corporation Sdn Bhd | 2011-07-15 |
| SMR SHOULDER SYSTEM - CTA HUMERAL HEADS (K110847) | Lima Corporate S.P.A. | 2011-07-15 |
| VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM (K111706) | Volcano Corporation | 2011-07-15 |
| EXACTECH GIBRALT SPINAL SYSTEM (K110197) | Exactech, Inc. | 2011-07-15 |
| E-CUBE 9 (K111864) | Alpinion Medical Systems Co., Ltd. | 2011-07-15 |
| BODY ANALYSIS SCALE, MODEL BG 17 (K110928) | Shenzhen Healthcare Electronic Technology Co., Ltd. | 2011-07-15 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR (K110857) | Shandong Zhanpeng Medical Products Co., Ltd. | 2011-07-15 |
| PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA (K103685) | Beijing Rongrui-Century Scie. & Tech. Co., Ltd. | 2011-07-15 |
| ACG-8511 PORTABLE ECG MONITOR (K110328) | Andon Health Co, Ltd. | 2011-07-15 |
| THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER (K111417) | Access Scientific, Inc. | 2011-07-15 |
| CENTRO FAMILY OF MANUAL WHEELCHAIRS (K111045) | Otto Bock Healthcare LP | 2011-07-15 |
| SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT (K102643) | Astoria-Pacific, Inc. | 2011-07-15 |
| AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM (K093755) | Andon Medical Co., Ltd. | 2011-07-15 |
| FALCON (K111416) | Viasonix , Ltd. | 2011-07-15 |
| WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST (K111560) | Guangzhou Wondfo Biotech Co., Ltd. | 2011-07-15 |
| OPIATE ENZYME IMMUNOASSAY (K110298) | Lin-Zhi International, Inc. | 2011-07-15 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, BLUE COLOR (K111240) | Xuzhou Full Sun Medical Products , Ltd. | 2011-07-14 |
| AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE (K111034) | Am USA | 2011-07-14 |
| SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE (K111856) | Apothecary Products, Inc. | 2011-07-14 |
| ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE (K110960) | Koon Seng Sdn Bhd | 2011-07-14 |
| NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER (K110285) | Nephros, Inc. | 2011-07-14 |
| CARA (K110869) | Diagnos, Inc. | 2011-07-14 |
| STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT (K111065) | Howmedica Osteonics Corp. Dba Stryker Orthopeadics | 2011-07-14 |
| OSSEOFUSE DENTAL IMPLANT SYSTEM (K110577) | Dynamic Innovations, Inc. | 2011-07-14 |
| TIGER SYRINGES AND NEEDLES (K110697) | Tiger Medical Products, Ltd. | 2011-07-14 |
| PERCUPRO MESSENGER BALLOON CATHETER (K094048) | Cardiosolutions, Inc. | 2011-07-14 |
| EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR (K101089) | Medica Corp. | 2011-07-13 |
| ECG PEN (K103077) | Meridian Dynamics Biomedical, Inc. | 2011-07-13 |
| SANTEVIEW (K111312) | Sehyun Co., Ltd. | 2011-07-13 |
| CARDIAC SCANNER AND PROCESSING SYSTEM (K110507) | Spectrum Dynamics (Israel) , Ltd. | 2011-07-13 |
| APEX KNEE SYSTEM, APEX ALL POLY TIBIA (K111062) | Omni Life Science, Inc. | 2011-07-13 |
| ATLAS SPINE PEDICLE SCREW SYSTEM (K110842) | Atlas Spine, Inc. | 2011-07-13 |
| MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR (K111652) | Microlife Intellectual Property GmbH | 2011-07-13 |
| POWDER FREE NITRILE EXAMINATION GLOVES (K110418) | W.A. Rubbermate Co., Ltd. | 2011-07-13 |
| VACCESS PTA DILATATION CATHETER (K111850) | C.R. Bard, Inc. | 2011-07-13 |
| PANOURA 18S (K111231) | The Yoshida Dental Mfg. Co., Ltd. | 2011-07-13 |
| EASYFIT SILKGEL NASAL MASK (K110884) | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2011-07-12 |
| ENDOLOGIX AFX INTRODUCER SYSTEM (K111747) | Endologix, Inc. | 2011-07-12 |
| ORTHOSORB RESORBABLE PINS (K111077) | DePuy Orthopaedics, Inc. | 2011-07-12 |
| ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM (K101997) | Ellipse Technologies, Inc. | 2011-07-12 |
| SOLANAS AVALON POSTERIOR FIXATION SYSTEM (K111076) | Alphatec Spine, Inc. | 2011-07-12 |
| EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT (K111036) | Medica Corporation | 2011-07-12 |
| TITAN TI SUTURE ANCHOR SYSTEM (K111397) | Arthrocare Corp. | 2011-07-12 |
| VLP FOOT TALUS PLATES, VLP PERCUTANEOUS CALCANEUS PLATES AND MISC VLP BONE SCREWS, PERI-LOC ANKLE FUSION PLATES (K110670) | Smith & Nephew, Inc. | 2011-07-12 |
| PRO FIXATION SYSTEM (K110538) | Synovis Orthopedic & Woundcare | 2011-07-12 |
| STERI-DENT, STERI-SURE (K094026) | Cpac, Inc. | 2011-07-12 |
| ARAGON SURGICAL RF SYSTEM - 5MM LAPAROSCOPIC INSTRUMENT (K110824) | Aragon Surgical, Inc. | 2011-07-11 |
| NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010 (K101194) | Carticept Medical, Inc. | 2011-07-11 |
| RHA2020 (K111531) | Annidis Health Systems Corp. | 2011-07-08 |
| STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR (K111150) | Steritec Products Mfg Co, Inc. | 2011-07-08 |
| ELECSYS PRECICONTROL VARIA 3 (K111506) | Roche Diagnostics | 2011-07-08 |
| HEMOSIL FACTOR VIII DEFICIENT PLASMA (K110237) | Instrumentation Laboratory CO | 2011-07-08 |
| HERO (K111601) | Medical Predictive Science Corp. | 2011-07-08 |
| DP-50 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K111435) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2011-07-08 |
| MEDIOSTAR NEXT (K111851) | Asclepion Laser Technologies GmbH | 2011-07-08 |
| PAINFUSOR CATHETER (K111031) | Plan 1 Health, S.R.L. | 2011-07-08 |
| HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS (K101381) | Integra LifeSciences Corporation | 2011-07-07 |
| ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA (K103714) | Ansell Healthcare Products, LLC | 2011-07-07 |
| SURELIFT PROLAPSE SYSTEM (K102815) | Neomedic International | 2011-07-07 |
| FORA P30 PLUS MULTI-MODE BLOOD PRESSURE MONITORING SYSTEM (K110044) | Foracare, Inc. | 2011-07-07 |
| APNEA RISK EVALUATION SYSTEM (ARES) (K111194) | Advanced Brain Monitoring, Inc. | 2011-07-07 |
| NEURO CHECK DEVICE WITH IO-FLEX WIRE (K110696) | Baxano, Inc. | 2011-07-07 |
| MODIFIED CONCENTRIC MICROCATHETER (K111619) | Concentric Medical, Inc. | 2011-07-06 |
| VIPER SYSTEMS (K111571) | Johnson & Johnson | 2011-07-06 |
| SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (BLUE/GREEN) (AND MULTIPLE LABELS) (K111012) | True Glove Factory | 2011-07-06 |
| REVLOK FENESTRATED SCREW SYSTEM (K110280) | Globus Medical, Inc. | 2011-07-06 |
| FIGURE 8 STERNOTOMY CLOSURE DEVICE (K110541) | Figure 8 Surgical, Incorporated | 2011-07-06 |
| PLATEAU SPACER SYSTEM (K111569) | Life Spine | 2011-07-06 |
| FORA POCT S10/TD-4258 BLOOD GLUCOSE MONITORING SYSTEM (K092688) | Taidoc Technology Corporation | 2011-07-06 |
| PARKER 500 (K110994) | Arjohuntleigh, Inc. | 2011-07-06 |
| OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM (K111326) | Graham Medical Technologies, LLC | 2011-07-06 |
| WIRELESS MONITORING SYSTEM (K110809) | Carefusion 303, Inc. | 2011-07-05 |
| NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT (K110925) | Novabone Products, LLC | 2011-07-05 |
| VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT (K110880) | Maine Standards Company, LLC | 2011-07-05 |
| ASCOM MOBILE MONITORING GATEWAY (MMG) (K111215) | Ascom (Sweden) AB | 2011-07-05 |
| TOTAL SHOULDER SYSTEM (K111596) | Shoulder Innovations, LLC | 2011-07-05 |
| SV DBS VRAIN ARRAY (K111259) | Midwest Rf, LLC | 2011-07-05 |
| SIMPLANT 2011 (K110300) | Materialise Dental NV | 2011-07-01 |
| MERIT MARQUIS FLOW SWITCH (K110643) | Merit Medical Systems, Inc. | 2011-07-01 |
| FORA POCT MANAGMENT SYSTEM (K111029) | Taidoc Technology Corporation | 2011-07-01 |
| TRIGEN LOW PROFILE BONE SCREW (K111025) | Smith & Nephew, Inc. | 2011-07-01 |
| XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST (K103776) | Luminex Molecular Diagnostics, Inc. | 2011-07-01 |
| ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN (K111179) | Siesta Medical, Inc. | 2011-07-01 |
| ATLANTEAN TRIGGER NEBULIZER (K102719) | Atlantean Corporation | 2011-07-01 |
| AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE (K111118) | American Medical Systems | 2011-07-01 |
| ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK (K102648) | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2011-07-01 |
| ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMEN (K110940) | Zimmer, Inc. | 2011-07-01 |
| SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A (K101306) | Fotona D.D. | 2011-07-01 |
| WELL-LIFE OTC EMS SYSTEM (K102786) | Well-Life Healthcare Limited | 2011-07-01 |
| STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS (K110682) | Case Medical, Inc. | 2011-07-01 |
| U2 HIP SYSTEM (K111546) | United Orthopedic Corp. | 2011-07-01 |
| ENDOSCOUT TRACKING SYSTEM (K111226) | Robin Medical, Inc. | 2011-07-01 |
| CORTEX CO2 / ER:YAG LASER SYSTEM (K110897) | Sandstone Medical Technologies, LLC | 2011-07-01 |
| PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150 (K103563) | Precision Medical, Inc. | 2011-07-01 |
| CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC... (K111117) | Teleflexmedical, Inc. | 2011-06-30 |
| SCANORA 3D (K110839) | Soredex Palodex Group OY | 2011-06-30 |
| EZONO 3000 (K102813) | Life-Tech, Inc. | 2011-06-30 |
| ENTERPRISE ELECTROPHYSIOLOGY SYSTEM (K110967) | Neuralynx, Inc. | 2011-06-30 |
| FATHOM (TM) 14 STEERABLE GUIDEWIRE (K111498) | Boston Scientific Corp | 2011-06-30 |
| FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX (K111485) | Boston Scientific Corporation | 2011-06-30 |