| DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS (K102638) | Diazyme Laboratories | 2010-11-30 |
| ICESENCE 3 (K102360) | IceCure Medical , Ltd. | 2010-11-29 |
| INNOVANCE D-DIMER, MODEL OPBP09 (K093626) | Siemens Healthcare Diagnostics | 2010-11-29 |
| VENUS FREEZE SYSTEM (K100586) | Venus Concept , Ltd. | 2010-11-29 |
| POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG (K102790) | Perusahaan Getah Asas Sdn. Bhd. | 2010-11-29 |
| DIGITAL FLAT PANEL X-RAY DETECTOR (K101590) | VATECH Co., Ltd. | 2010-11-29 |
| EQUINOX CO2 LASER SYSTEM (K100487) | Eclipsemed Global, Inc. | 2010-11-29 |
| ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA (K101794) | Advanced Surgical Concepts | 2010-11-29 |
| MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES (K100920) | Sequal Technologies Co., Ltd. | 2010-11-29 |
| MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX (K101784) | Great Batch Medical | 2010-11-26 |
| ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND VENACUREEVLT PROCEDURE KIT (K100199) | AngioDynamics, Inc. | 2010-11-26 |
| FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE (K102548) | Footprint Medical, Inc. | 2010-11-26 |
| PLASMALUXLS (K100628) | Daavlin Distributing Co. | 2010-11-24 |
| AXLE INTERSPINOUS FUSION SYSTEM (K101471) | X-Spine Systems, Inc. | 2010-11-24 |
| AERODR SYSTEM (K102349) | Konica Minolta Medical & Graphic, Inc. | 2010-11-24 |
| A-DEC 200 DENTAL SYSTEM (K102234) | A-Dec, Inc. | 2010-11-24 |
| MAX-IF1000 (K100246) | Bio Protech, Inc. | 2010-11-24 |
| HTO PLATING SYSTEM (K102505) | Aesculap Implant Systems, LLC | 2010-11-24 |
| CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM (K101534) | Conmedcorp | 2010-11-24 |
| VITAL SIGNS MONITOR MODEL M3B (K101539) | Edan Instruments, Inc. | 2010-11-24 |
| SIMPLEXA FLU A/B & RSV (K102170) | Focus Diagnostics, Inc. | 2010-11-24 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K102690) | Andon Health Co, Ltd. | 2010-11-24 |
| ARROW ANATOMICAL SHOULDER SYSTEM (K093599) | Fournitures Hospitalieres Industrie | 2010-11-24 |
| ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW (K102429) | Wrightmedicaltechnologyinc | 2010-11-23 |
| SCANVIEW HER2/NEU FISH SYSTEM (K101291) | Applied Spectral Imaging , Ltd. | 2010-11-23 |
| ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0 (K101574) | Ark Diagnostics, Inc. | 2010-11-23 |
| GS 3000 (K102202) | Emsi | 2010-11-23 |
| TRINITY ACETABULAR SYSTEM (K093472) | Corin USA | 2010-11-23 |
| CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE (K102339) | Conmed Linvatec | 2010-11-23 |
| DMP ETCHING GEL (K102255) | Dmp, Ltd. | 2010-11-23 |
| PREASSEMBLED SURGICAL WASH SET (K103202) | Sorin Group Italia S.R.L. | 2010-11-23 |
| INTEGRA ELECTRODE TUNNELING NEEDLE (K102802) | Integra LifeSciences Corporation | 2010-11-23 |
| DMP SINGLE BONDING (K102254) | Dmp, Ltd. | 2010-11-23 |
| FIBER FORCE (K102207) | Synca Marketing, Inc. | 2010-11-23 |
| ACCULMAING (K102849) | Radiology Information Systems, Inc. | 2010-11-23 |
| DEPUY RECLAIM REVISION HIP SYSTEM (K102080) | Depuy(Ireland) | 2010-11-23 |
| EASYSUITE SURGICAL LIGHT CONTROL (ESLC) (K102791) | Image Stream Medical, Inc. | 2010-11-23 |
| EMERGE MEDICAL CANNULATED SCREW FIXATION SYSTEM (K102343) | Emerge Medical | 2010-11-23 |
| CLICKFINE PEN NEEDLE (K102108) | Ypsomed AG | 2010-11-23 |
| OMNI EXPRESS (K103268) | Infinium Medical | 2010-11-23 |
| ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL (K102904) | Siemens Healthcare Diagnostics | 2010-11-23 |
| PATCHASSIST LARGE (K103269) | Polytouch Medical, Ltd. | 2010-11-23 |
| BIOGEL ORTHOPRO INDICATOR UNDERGLOVE (K101163) | Molnlycke Health Care USA | 2010-11-23 |
| LOCKING BONE SCREW MODEL HCQ04, HCZ04 (K100721) | Changzhou Orthmar Medical Instrument Co., Ltd. | 2010-11-23 |
| PVS MODEL 1.0 (K102237) | Medcom GmbH | 2010-11-23 |
| SMITH & NEPHEW MILTI-PURPOSE STERILIZATION TRAY MODEL 72202428 (K102122) | Smith & Nephew, Inc. | 2010-11-22 |
| LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2, LIGHTWALKER ST-E, MODEL M002-6A/2, LIGHTWALKER ST-N (K101817) | Fotona D.D. | 2010-11-22 |
| SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT (K103104) | Howmedica Osteonics Corp. | 2010-11-22 |
| HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET) (K101547) | Henke-Sass, Wolf GmbH | 2010-11-22 |
| AIDI DENTAL IMPLANT SYSTEM (K101755) | Aidi Biomedical, LLC | 2010-11-22 |
| ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY (K103263) | Covidien, Formerly US Surgical A Divison of Tyco H | 2010-11-22 |
| FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX (K102519) | Flexible Stenting Solutions, Inc. | 2010-11-22 |
| CSTS SCREW (K093055) | Orthopro, LLC | 2010-11-22 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K102444) | Zibo Yingbo Medical Products, Inc. | 2010-11-22 |
| MEDRANGE ELECTROSURGICAL GENERATOR (K102114) | Medrange Corporation | 2010-11-22 |
| POWDERFREE BLACK NITRILE EXAMINATION GLOVES (K102620) | Pt. Medisafe Technologies | 2010-11-22 |
| SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS (K102308) | Dentium Co., Ltd. | 2010-11-22 |
| SYSTEM 1E CHEMICAL INDICATOR (K102217) | STERIS Corporation | 2010-11-22 |
| SPECTRA OPTIA R APHERESIS SYSTEM (K103090) | Caridianbct, Inc.. | 2010-11-19 |
| EQUASHIELD SYSTEM PROTECTIVE PLUS (K101940) | Equashield Medical , Ltd. | 2010-11-19 |
| NEXT GENERATION INFUSED (R) OR TOWEL (HEMED), NEXT GENERATION INFUSED (R) OR TOWEL (WITH BINDING) MODEL HUCKCR17X27MH, H (K094016) | Hinson and Hale Medical Technologies, Inc. | 2010-11-19 |
| NANOCERAM- BRIGHT (K102257) | Dmp, Ltd. | 2010-11-19 |
| BARRIER N95 PARTICULATE RESPIRATOR (K102923) | Molnlycke Health Care | 2010-11-19 |
| SLEEP APP (K100185) | Sleep Medicine Network, Inc. | 2010-11-19 |
| OSTEON, OSTEON SINUS, OSTEON LIFTING (K102015) | Genoss Co., Ltd. | 2010-11-19 |
| CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 (K102147) | Cardioquip Llp | 2010-11-19 |
| ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE (K103057) | Asahi Intecc Co., Ltd. | 2010-11-19 |
| VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR ETHYLENE OXIDE, MODELS: SELF AND HEAT SEAL POUCHES, HEAT SEAL TU (K092745) | STERIS Corporation | 2010-11-19 |
| VACUETTE PREMIUM SAFETY BLOOD COLLECTION SET (K102010) | Medpro Safety Products, Inc. | 2010-11-19 |
| BRIGHTWAY TM BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE. (GREY COLOR) (K102880) | Brightway Holdings Sdn. Bhd. | 2010-11-19 |
| VOCO IONOFIL MOLAR AC QUICK (K102612) | Voco GmbH | 2010-11-19 |
| PENRITH ELETTRA ULTRASOUND SYSTEM (K100598) | Penrith Corporation | 2010-11-19 |
| OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS (K093495) | American Diagnostic Corp. | 2010-11-19 |
| 20.1 INCH (51 CM) COLOR LCD MONITOR CCL208 (CDL2013A) (K092728) | Totoku Electric Co., Ltd. | 2010-11-19 |
| NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K101822) | Sgmp Co., Ltd. | 2010-11-19 |
| UNIVERSAL IRRIGATION SOLUTION HYBRID (K102855) | Byrne Medical, Inc. | 2010-11-19 |
| REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR (K103118) | Hoya Photonics, Inc. | 2010-11-19 |
| SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS (K103124) | Stryker Corporation | 2010-11-19 |
| SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM (K102390) | Sonosite,Inc. | 2010-11-19 |
| I-ROOT (K100450) | S-Denti Co., Ltd. | 2010-11-18 |
| RANDOX METHADONE ASSAY (K092272) | Randox Laboratories, Ltd. | 2010-11-18 |
| MOORVMS-PRES PRESSURE CUFF CONTROLLER (K102433) | Moor Instruments, Ltd. | 2010-11-18 |
| BAHADIR STERILIZATION TRAYS (K102146) | Bahadir USA Corp. | 2010-11-18 |
| AQUILION ONE VERSION 4.6 W/DUAL ENERGY SCAN SYSTEM, MODEL TSX-301A/2 (K093891) | Toshibamedical Systems Corporation | 2010-11-18 |
| ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER (K102043) | Rex Medical | 2010-11-18 |
| ELECSYS PTH CALCHECK 5 (K103162) | Roche Diagnostics | 2010-11-18 |
| D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES (K101368) | Dragon Heart Medical, Inc. | 2010-11-18 |
| COULTER 4C-EX 300 CELL CONTROL (K100607) | Beckman Coulter, Inc. | 2010-11-18 |
| CRITICOOL PRO (K102112) | Mtre Advanced Technology , Ltd. | 2010-11-18 |
| K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING (K100720) | Kawasumi Laboratories, Inc. | 2010-11-18 |
| VELSCOPE VX (K102083) | Led Dental, Inc. | 2010-11-18 |
| MICROPLEX COIL SYSTEM- COSMOS (K102365) | MicroVention, Inc. | 2010-11-18 |
| MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1 (K101031) | Masimo Corporation | 2010-11-18 |
| SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE (K101244) | Truer Medical, Inc. | 2010-11-18 |
| VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0 (K102377) | A Plus Medical | 2010-11-18 |
| SENSOMETRICS SOFTWARE (K101133) | Dpcom AS | 2010-11-18 |
| HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P (K102236) | D.T. Davis Enterprises Ltd. T/A Hovertech Int'L | 2010-11-18 |
| WIRELESS DR IMAGING OPTION-WDR1 (K102615) | Ge Medical Systems, LLC | 2010-11-18 |
| FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440 (K093071) | Fundus Photo, LLC | 2010-11-17 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K102097) | Shijiazhuang Great Vision Plastic Products Co., LT | 2010-11-17 |