| NIHON KOHDEN QP-160AK EEG TREND PROGRAM (K092573) | Nihon Kohden America, Inc. | 2010-07-09 |
| CLAVE NEUTRON (K100434) | Icu Medical, Inc. | 2010-07-09 |
| SECURACATH UNIVERSAL (K092306) | Interrad Medical, Inc. | 2010-07-09 |
| 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM (K092853) | Galix Biomedical Instrumentation, Inc. | 2010-07-09 |
| FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM (K100405) | Taidoc Technology Corporation | 2010-07-09 |
| PROSTHODONTIC SCREWDRIVER , MODEL IA-400 (K100600) | W&H Dentalwerk Buermoos GmbH | 2010-07-09 |
| PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT (K100461) | Riverpoint Medical | 2010-07-08 |
| CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX (K101032) | Cardo Medical, Inc. | 2010-07-08 |
| HI-TORQUE WINN GUIDE WIRE FAMILY (K101648) | Abbott Vascular, Inc. | 2010-07-08 |
| MODIFICATION TO:RADIUS SPINAL SYSTEM (K101144) | Stryker Spine | 2010-07-08 |
| SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM (K101060) | Siesta Medical, Inc. | 2010-07-08 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) (K100057) | Tangshan Kangyuan Glove Co., Ltd. | 2010-07-08 |
| HM-LAMP II (K100234) | Hillusa, Inc. | 2010-07-08 |
| VISUMAX LASER KERATOME (K100253) | Carl Zeiss Meditec, AG | 2010-07-08 |
| IMPELLA CONTROLLER (K093801) | Abiomed, Inc. | 2010-07-08 |
| ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 (K100705) | Zyno Medical, LLC | 2010-07-08 |
| THERACLEAR (K101415) | Theravant Corporation | 2010-07-08 |
| XYLOS VESSEL GUARD (K100984) | Xylos Corporation | 2010-07-07 |
| ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM (K100728) | Zeus Scientific, Inc. | 2010-07-06 |
| 6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS (K101195) | Lin-Zhi International, Inc. | 2010-07-06 |
| INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP) (K100051) | Alfa Scientific Designs, Inc. | 2010-07-06 |
| NON-CONTACT FOREHEAD INFRARED THERMOMETER, MODEL DT-8806H, BODY INFRARED THERMOMETER, MODEL DT-8806 AND DIGITAL INFRARED (K101736) | Shenzhen Everbest Machinery Industry Co., Ltd. | 2010-07-06 |
| JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136 (K100287) | U.S. Army Medical Material Development Command | 2010-07-06 |
| NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG (K093383) | bioMerieux, Inc. | 2010-07-06 |
| LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727 (K091409) | Roche Molecular Systems, Inc. | 2010-07-06 |
| EVIS EXERAII 180 SYSTEM (K100584) | Olympus Medical Systems Corporation | 2010-07-02 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR , MODEL KN-550 (K100620) | Harvard Medical Devices , Ltd. | 2010-07-02 |
| BONE PLUS BCP (K090950) | Megagen Implant Co., Ltd. | 2010-07-02 |
| MEDLINE PVC URETHRAL CATHETER (K100302) | Medline Industries, Inc. | 2010-07-02 |
| PROTOE ENDOSORB SMALL HAMMER TOE PIN (K100414) | Merete Medical GmbH | 2010-07-02 |
| ACTIPROTECT UC N95 RESPIRATOR (K093189) | Glaxosmithkline Consumer Healthcare | 2010-07-02 |
| ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT) (K101667) | St Jude Medical | 2010-07-02 |
| MD VISION SYSTEM (K101474) | Perkins Healthcare Technologies | 2010-07-02 |
| NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR WHITE, NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR BLUE (K100979) | Jiangsu Sunshine Plastic Products, Co., Ltd. | 2010-07-02 |
| CHEETAH NICOM SYSTEM (K101487) | Cheetah Medical, Inc. | 2010-07-02 |
| DSS STABILIZATION SYSTEM (K101083) | Paradigm Spine, LLC | 2010-07-02 |
| MERITS MODEL N SERIES NEBULIZER COMPRESSORS (K092859) | Merits Health Products Co., Ltd. | 2010-07-02 |
| MISTRAL-AIR WARMING SYSTEM (K101705) | The Surgical Company International B.V. | 2010-07-02 |
| ELI 250 ELECTROCARDIOGRAPH (K101403) | Mortara Instrument, Inc. | 2010-07-02 |
| KMD-MARK1 TISSUE MARKER (K093473) | Kent Medical Devices, Inc. | 2010-07-02 |
| THERMODILUTION CATHETER (K101669) | Biosensors Intl. Pte. , Ltd. | 2010-07-01 |
| LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC (K101190) | Led Intellectual Properties, LLC | 2010-07-01 |
| EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031 (K101457) | Eps Bio Technology Corp. | 2010-07-01 |
| GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN (K101557) | Etex Corp. | 2010-07-01 |
| MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCHBP OFFICE TARGET (BP3MD1-4). (K101512) | Microlife Intellectual Property GmbH | 2010-07-01 |
| IP-SET (K101685) | Integral Process Sas | 2010-07-01 |
| GYNECARE TVT ABBREVO CONTINENCE SYSTEM (K100936) | ETHICON, Inc. | 2010-07-01 |
| POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) (K101293) | Pt. Smartglove Indonesia | 2010-07-01 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (BLUE, WHITE, PINK) (K101132) | Hong DI Plastic Products Co., Ltd. | 2010-07-01 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE) (K100059) | Tangshan Zhongpu Plastic Products Co., Ltd. | 2010-07-01 |
| SYNTHES MATRIX SYSTEM (K100634) | Synthes (Usa) | 2010-07-01 |
| PK SUPERPULSE SYSEM GENERATOR MODEL 744000 (K100816) | Gyrus Acmi, Inc. | 2010-07-01 |
| ANTI-MUTATED CITRULLINATED VIMENTIN EIA (K092399) | Orgentec Diagnostika GmbH | 2010-07-01 |
| RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26 (K093877) | Edwards Lifesciences, LLC | 2010-07-01 |
| EARPROBE (K100661) | Path Medical GmbH | 2010-07-01 |
| BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST (K100817) | Princeton BioMeditech Corp. | 2010-07-01 |
| NEV'S INK AUTOCLAVE TAPES (K101580) | Nev'S Ink, Inc. | 2010-07-01 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE,BLUE, PINK) (K101135) | Hongze Plastic Technology Co., Ltd. | 2010-07-01 |
| SPINESMITH CYNCH SPINAL SYSTEM (K101085) | Spine Smith Partners L.P. | 2010-07-01 |
| CERULEAU ELECTROSURGICAL PROBE (K101711) | Nuortho Surgical, Inc. | 2010-07-01 |
| TILOCK PEDICLE SCREW SYSTEM (K100757) | Genesys Spine | 2010-07-01 |
| WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS (K100275) | Olympus Winter & Ibe GmbH | 2010-07-01 |
| TYCHE PEDICLE SCREW SYSTEM (K100373) | Kyung Won Medical Co., Ltd. | 2010-06-30 |
| LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 (K093993) | Infraredx, Inc. | 2010-06-30 |
| S-LIF INTERVERTEBRAL BODY FUSION DEVICE (K092815) | Spinefrontier, Inc. | 2010-06-30 |
| ZEN CORDLESS PROPHY SYSTEM (K101612) | Discus Dental, LLC | 2010-06-30 |
| PEEK PREVAIL CERVICAL INTERBODY DEVICE (K094042) | Medtronic Sofamor Danek | 2010-06-30 |
| APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010 (K101575) | Omnlife Science | 2010-06-30 |
| UROSKOP OMNIA (K101491) | Siemens Medical Solutions USA, Inc. | 2010-06-30 |
| HANSON MEDICAL FACIAL IMPLANTS (K090803) | Hanson Medical, Inc. | 2010-06-30 |
| LATITUDE ELBOW PROSTHESIS (K100562) | Tornier, Inc. | 2010-06-29 |
| LITETOUCH MASK (K100285) | Respironics New Jersey, Inc. | 2010-06-29 |
| RII INFRARED EAR THERMOMETER, MODEL: TH60N (K101253) | Radiant Innovation, Inc. | 2010-06-29 |
| MODIFICATION TO INTEL HEALTH GUIDE PHS6000 (K101178) | Intel Corp. | 2010-06-29 |
| NITRITECH OR MULTIPLE PRIVATE LABEL NON STERILE POWDERED NITRILE EXAMINATION GLOVES (K093516) | Summit Glove, Inc. | 2010-06-29 |
| BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774 (K101502) | Becton, Dickinson & CO | 2010-06-29 |
| WAVESTATE NEUROMONITOR (K092625) | Wavestate, Inc. | 2010-06-29 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 (K100940) | Andon Health Co, Ltd. | 2010-06-29 |
| NITRITECH OR MULTIPLE PRIVATE LABEL NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVE (K093517) | Summit Glove, Inc. | 2010-06-29 |
| LIPCOLLECTOR II (K101713) | Human Med AG | 2010-06-29 |
| FRANKENMAN SURGICAL STAPLERS (K101378) | Suzhou Frankenman Medical Equipment Co., Ltd. | 2010-06-29 |
| A4-XLR8 FOAM DRESSING (K092992) | Genadyne Biotechnologies, Inc. | 2010-06-29 |
| WRIST ARTHRODESIS NAIL SYSTEM (K092720) | Skeletal Dynamics, LLC | 2010-06-29 |
| BELLECUP (K092985) | Librette, Inc. | 2010-06-28 |
| FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000 (K100947) | Calibra Medical, Inc. | 2010-06-28 |
| G+ SYSTEM (K101344) | Glytec, LLC (Formally Known AS Glucotec, Inc.) | 2010-06-28 |
| MEDPOR FIXATION SYSTEM (K091807) | Porex Surgical, Inc. | 2010-06-28 |
| TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277 (K100322) | Taidoc Technology Corporation | 2010-06-28 |
| COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN (K100694) | Tekmedic (M) Sdn Bhd | 2010-06-25 |
| SHIKANI SPEAKING VALVE (K100995) | Shikani Medical, LLC | 2010-06-25 |
| MOBIVISION (K100001) | Almana Medical Imaging | 2010-06-25 |
| ZURA TEE SYSTEM WITH CLARITEE PROBE (K100989) | Imacor, Inc. | 2010-06-25 |
| MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM (K093104) | Medyssey Co, Ltd. | 2010-06-25 |
| SYNTEC OSTEO-PLATE AND SCREW FIXATION (K092889) | Syntec Scientific Corp. | 2010-06-25 |
| STRYKER KNIFELIGHT (K100884) | Howmedica Osteonics Corp. | 2010-06-25 |
| SINGLE SITE FLEXIBLE BLADELESS OBTURATOR (K101671) | Teleflexmedical, Inc. | 2010-06-25 |
| ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES (K091327) | Alden Optical Labs., Inc. | 2010-06-25 |
| BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09 (K093196) | Cousin Biotech Sas | 2010-06-25 |
| Z.ONE ULTRA ULTRASOUND SYSTEM (K101091) | Zonare Medical Systems, Inc. | 2010-06-25 |
| IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET (K091849) | Immunodiagnostic Systems, Inc. | 2010-06-25 |