| STA-HYBRID HEP CALIBRATOR (K092937) | Diagnostica Stago, Inc. | 2010-08-02 |
| NEODENT IMPLANT SYSTEM (K101207) | Jjgc Industria E Comercio DE Materiais Dentarios S | 2010-08-02 |
| OPTETRAK LOGIC COMBINATION TIBIAL TRAY (K101981) | Exactech, Inc. | 2010-08-02 |
| ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 (K100200) | Siemens Healthcare Diagnostics | 2010-08-02 |
| MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES (K101653) | Miltex, Inc. | 2010-08-02 |
| SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM (K101409) | STERIS Corporation | 2010-08-02 |
| TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U (K093079) | Hobbs Medical, Inc. | 2010-08-02 |
| LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV (K091303) | Bio-Rad Laboratories | 2010-08-02 |
| EXACTECH EQUINOXE, PLATFORM FRACTURE STEM (K101909) | Exactech, Inc. | 2010-08-02 |
| REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012 (K100741) | Encore Medical L.P. | 2010-08-02 |
| ASCENSION TOTAL PLATE SYSTEM (K100502) | Ascension Orthopedics, Inc. | 2010-08-02 |
| THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER (K100819) | Onset Medical Corporation | 2010-08-02 |
| RANGE SPINAL SYSTEM (K100851) | K2m, Inc. | 2010-08-02 |
| INTRAVSCULAR ADMINISTRATION SET (K100946) | Terumo Europe N.V. | 2010-08-02 |
| SLENDERTONE FLEX MAX, MODEL 517 US (K100556) | Bio-Medical Research, Ltd. | 2010-08-02 |
| ZIMMER SEGMENTAL SYSTEM PROXIMAL FEMORAL COMPONENT AND SMALL DIAMETER STEM EXTENSIONS (K101296) | Zimmer, Inc. | 2010-07-30 |
| AMIGO CLASSIC FD (K101507) | Amigo Mobility Intl., Inc. | 2010-07-30 |
| ARTHREX BIOWIRE (K091018) | Arthrex, Inc. | 2010-07-30 |
| EMS PIEZON MASTER 700 (K093000) | E.M.S Electro Medical Systems S.A | 2010-07-30 |
| VEGA KNEE SYSTEM (K101281) | Aesculap Implant System, Inc. | 2010-07-30 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL: KD-5963NU, KD-5008 (K101010) | Andon Health Co, Ltd. | 2010-07-30 |
| OPTIBOND XTR (K101423) | Kerr Corporation | 2010-07-30 |
| VIGILANT EEG MONITOR MODEL VIGILANT 2.0 (K101386) | Infinite Biomedical Technologies, LLC | 2010-07-30 |
| ENDOSKELETON TC (K100889) | Titan Spine, LLC | 2010-07-29 |
| Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6 (K102050) | Advanced Technology Laser Co., Ltd. | 2010-07-29 |
| CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (K101261) | C.R. Bard, Inc. | 2010-07-29 |
| ZOLL PROPAQ MD (K100654) | Zoll Medical Corporation, World Wide Headquarters | 2010-07-29 |
| GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H (K093608) | Gambro Renal Products, Inc. | 2010-07-29 |
| BIOGENNIX RPC (K093342) | Biogennix, LLC | 2010-07-29 |
| IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGY (K093489) | Rymed Technologies, Inc. | 2010-07-29 |
| ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O (K101521) | Philips Medical Systems | 2010-07-29 |
| FORA CONTROL SOLUTION, TAIDOC CONTROL SOLUTION (K093724) | Taidoc Technology Corporation | 2010-07-29 |
| POWERWIRE RADIOFREQUENCY GUIDEWIRE (K101615) | Baylis Medical Co., Inc. | 2010-07-28 |
| AMPHETAMINES II ASSAY (K093664) | Roche Diagnostics Corp. | 2010-07-28 |
| ADVIA 2120/2120I BODY FLUIDS (K090346) | Siemens Healthcare Diagnostics | 2010-07-28 |
| MROPEN (K101295) | Paramed S.R.L. | 2010-07-28 |
| ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM (K101678) | Spineart | 2010-07-28 |
| PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601 (K101949) | Shanghai Chenguang Medical Technologies Co, Ltd. | 2010-07-28 |
| XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10 (K101879) | Cepheid | 2010-07-28 |
| FIREBIRD SPINAL FIXATION SYSTEM (K093926) | Blackstone Medical, Inc. | 2010-07-28 |
| HYDROFIX VASO SHIELD, MODEL HVS-001-0610 (K101826) | Mimedx Group, Inc. | 2010-07-28 |
| JOINSOON ELECTRONICS MFG CO., LTD INFRARED EAR THERMOMETER, MODEL TT-001 (K101322) | Joinsoon Electronics Mfg Co, Ltd. | 2010-07-28 |
| VARIOUS DENTAL IMPLANTS (K100411) | Grundy Advanced Biomedical Systems, LLC | 2010-07-28 |
| DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404 (K101276) | Chemence Medical Products, Inc. | 2010-07-28 |
| TALYMED (K102002) | Marine Polymer Technologies | 2010-07-28 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K101663) | Hebei Excellent Plastic Co., Ltd. | 2010-07-27 |
| PROWESS PANTHER PROARC, MODEL VERSION 5.0 (K101076) | Prowess, Inc. | 2010-07-27 |
| TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE (K100536) | 3M Unitek | 2010-07-27 |
| NAVIAID ICVI DEVICE (K101191) | Smart Medical Systems , Ltd. | 2010-07-27 |
| RDT3 HANDPIECE HEAD MODEL RDT3 (K101172) | Redent Nova, Ltd. | 2010-07-27 |
| POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO (K101026) | Vidacare Corporation | 2010-07-27 |
| AESCULAP STERILCONTAINER S (K093493) | Aesculap, Inc. | 2010-07-27 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES (K101664) | Hebei Excellent Plastic Co., Ltd. | 2010-07-27 |
| MAM COOLER (K093266) | Mam International AG | 2010-07-27 |
| SYNAPSE 3D BASIC TOOLS (K101662) | Fujifilm Medical System U.S.A., Inc. | 2010-07-26 |
| PHILIPS OBTRACEVUE MODEL SW REV. G.00 (K100420) | Philips Medizin Systeme Boeblingen GmbH | 2010-07-26 |
| THE PANPAC SUCTION CURETTE (K092982) | Panpac Medical Corporation | 2010-07-26 |
| MED-SEG, MODEL BTMS 1000 (K092328) | Bartron Medical Imaging, Inc. | 2010-07-26 |
| INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5 (K101833) | Infimed, Inc. | 2010-07-23 |
| MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES (K100958) | Baxano, Inc. | 2010-07-23 |
| CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH (K101866) | Cryolife, Inc. | 2010-07-23 |
| PROFAST+ ASSAY (K101855) | Gen-Probe Prodesse, Inc. | 2010-07-23 |
| ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM (K101314) | Boston Scientific Corp | 2010-07-23 |
| MINI-TONG (K101101) | Mini Lap Technologies, Inc. | 2010-07-23 |
| ADVANIX DOUBLE PIGTAIL BILIARY STENT (K101786) | Boston Scientific Corp | 2010-07-23 |
| DEFCON TSA/TSH DENTAL IMPLANT SYSTEM (K092261) | Impladent, S.L. | 2010-07-23 |
| QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB (K100813) | Pulse Biomedical, Inc. | 2010-07-23 |
| S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM (K100147) | Aesculap Implant System, Inc. | 2010-07-23 |
| DETAX IMPLANTLINK SEMI (K100247) | Detax GmbH & Co. KG | 2010-07-23 |
| PIONEER PLUS CATHETER, MODEL PLUS 120 (K101777) | Medtronic Vascular | 2010-07-23 |
| THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 (K091939) | Thermedx, LLC | 2010-07-23 |
| REPROCESSED COMPRESSION SLEEVES (K100909) | Ascent Healthcare Solutions | 2010-07-23 |
| TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM (K101206) | Alexandria Research Technologies, LLC | 2010-07-23 |
| AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1 (K100133) | Airstrip Technologies, LP | 2010-07-23 |
| MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01 (K100543) | Medisiss | 2010-07-23 |
| CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467 (K101240) | DePuy Orthopaedics, Inc. | 2010-07-23 |
| GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U (K100682) | Wallac OY | 2010-07-23 |
| PRO-TOE VO HAMMERTOW IMPLANT SYSTEM (K101165) | Wrightmedicaltechnologyinc | 2010-07-23 |
| GUARDIAN CONNECTION (K101214) | Maulin Medical, LLC | 2010-07-23 |
| SCOUTPRO ACS (K101776) | Biotronik, Inc. | 2010-07-23 |
| IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081 (K100488) | Shenzhen Dongdixin Technology Co., Ltd. | 2010-07-22 |
| QUANTA DIODE LASER SYSTEM (K100558) | Quanta System Spa | 2010-07-22 |
| VENUS BASIC SPINAL FIXATION SYSTEM (K100706) | L&K BIOMED Co., Ltd. | 2010-07-22 |
| AUDIT MICROCV PROCALCITONIN LINEARITY (K101434) | Aalto Scientific, Ltd. | 2010-07-22 |
| CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES (K101576) | Team Innovations, Inc. | 2010-07-22 |
| YRNSORTIP OXIMANOMETER (K093981) | Cnoga Medical , Ltd. | 2010-07-22 |
| SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS (K101972) | Solaris Medical Technology, Inc. | 2010-07-22 |
| IMPIX LUMBAR INTERBODY DEVICE (K100544) | Medicrea Technologies | 2010-07-22 |
| 20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500 (K100640) | B.Braun Medical, Inc. | 2010-07-22 |
| CPR MASK (K083418) | Firstar Healthcare Co., Ltd. | 2010-07-22 |
| ALEUTIAN IBF SYSTEM (K101302) | K2m, Inc. | 2010-07-22 |
| RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V (K101857) | Instrumentation Industries, Inc. | 2010-07-22 |
| PANPAC VAGINAL PESSARY (K092981) | Panpac Medical Corporation | 2010-07-22 |
| DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000 (K092830) | VATECH Co., Ltd. | 2010-07-21 |
| WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0 (K101674) | Athena Gtx | 2010-07-21 |
| GIRAFFE AND PANDA WARMERS (K101804) | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2010-07-21 |
| VISCOPE, MODEL 100P,100S (K100531) | Hd Medical Services (India) Pvt.Ltd | 2010-07-21 |
| ECT DIGITAL THERMOMETER (K101043) | Changshan Estar Electronics Co., Ltd. | 2010-07-21 |
| ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM (K101255) | Alphatec Spine, Inc. | 2010-07-21 |
| GIRAFFE INCUBATOR (K101778) | Ohmeda Medical | 2010-07-21 |