| MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000 (K091763) | Instratek, Inc. | 2009-08-14 |
| FOXQ 980 LASER (K091059) | A.R.C Laser GmbH | 2009-08-13 |
| IMM DENTAL IRRIGATION TUBING SET (K090727) | Innovative Medical Manufacturing Co. | 2009-08-13 |
| TROPAZONE LOTION (K090337) | Midlothian Laboratories | 2009-08-13 |
| TT-102 (K081246) | Tissue Technologies Holdings, LLC | 2009-08-13 |
| CHROMA, MODEL: RZ153C (K083382) | Scottcare Corporation | 2009-08-13 |
| UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+ (K091238) | Impact Instrumentation, Inc. | 2009-08-13 |
| ALMA LASERS ALEX755 MODULE (K090571) | Alma Lasers , Ltd. | 2009-08-13 |
| REVERE 6.35 STABILIZATION SYSTEM (K091782) | Globus Medical, Inc. | 2009-08-13 |
| ILLUSION POWDER FREE EXAM GLOVES, NATURAL COLOR WITH VANILLA SCENT, ORANGE COLOR WITH CITRIC SCENT AND PINK COLOR (K083571) | Purna Bina Sdn Bhd | 2009-08-13 |
| HELIO2 BLENDER (K090781) | Precision Medical, Inc. | 2009-08-13 |
| G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE (K080844) | Gyrus Acmi, Inc. | 2009-08-13 |
| ANOVA CONTAINMENT DEVICE (K063461) | Anova Corporation | 2009-08-13 |
| LIGHTLAS SELECTOR (K090774) | Lightmed Corp. | 2009-08-13 |
| TRUSS THORACOLUMBAR PLATE SYSTEM (K092108) | Globus Medical, Inc. | 2009-08-13 |
| TANSCU O2 (K090681) | Electrochemical Oxygen Concepts, Inc. | 2009-08-12 |
| MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST (K092223) | Binax, Inc. | 2009-08-12 |
| LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331 (K091453) | DePuy Orthopaedics, Inc. | 2009-08-12 |
| HDR PROSTATE TEMPLATE AND ACCESSORIES (K091230) | Photon Technologies Corporation | 2009-08-12 |
| OMNISURE URETHRAL SLING, MODEL OTK52 (K092203) | Mpathy Medical Devices, Ltd. | 2009-08-12 |
| SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR (K092315) | Sorin Group Italia S.R.L. | 2009-08-12 |
| AIXPLORER ULTRASOUND SYSTEM (K091970) | Supersonic Imagine | 2009-08-12 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K090551) | Tangshan Zhongpu Plastic Products Co., Ltd. | 2009-08-12 |
| SWITCH TRT (K091552) | Audifon GmbH & Co. KG | 2009-08-12 |
| FOOTPRINT URINARY DRAINAGE CATHETER (K090576) | Footprint Medical | 2009-08-12 |
| INVISION SYSTEM (K083728) | Inneroptic Technology, Inc. | 2009-08-12 |
| NIPRO DISPOSABLE SYRINGE (K091279) | Nipro Medical Corporation | 2009-08-12 |
| PROTEUS 235 PROTON THERAPY SYSTEM (K091629) | Ion Beam Applications S.A. | 2009-08-11 |
| POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400 (K090342) | Sophysa SA | 2009-08-11 |
| JIAJIAN ACUPUNCTURE NEEDLE (K090199) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2009-08-11 |
| SENTINEL SPINAL SYSTEM (K090343) | Life Spine | 2009-08-11 |
| DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT, (K091410) | Spes Medica Srl | 2009-08-11 |
| AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS (K092238) | Agfa Healthcare N.V. | 2009-08-11 |
| ZOOM-100DC (K082886) | Brainscope Company, Inc. | 2009-08-10 |
| AMSURE HYDROPHILIC LATEX FOLEY CATHETER (K091699) | Amsino International, Inc. | 2009-08-10 |
| SCALAR WAVE LASER SYSTEM (K091158) | Stellar Lasers | 2009-08-10 |
| GDX VCC WITH ECC SOFTWARE (K082016) | Carl Zeiss Meditec, Inc. | 2009-08-10 |
| MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400 (K091357) | Kimberly-Clark Corp. | 2009-08-10 |
| ACCELL EVO3C (K091193) | Isotis Orthobiologics, Inc. | 2009-08-10 |
| MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP (K090662) | Masimo Corporation | 2009-08-10 |
| SONIC AIR MM1500 + (MID), MODEL 50400014 (K081268) | Micro-Mega Societe Anonyme | 2009-08-10 |
| POWERED VINYL PATIENT EXAMINATION GLOVES (K091521) | Shijiazhuang Century Plastic Co., Ltd. | 2009-08-10 |
| UC-CARE WARMING SYSTEM (K090978) | UC-CARE , Ltd. | 2009-08-10 |
| IBEX SPINAL SYSTEM (K091381) | Ebi, L.P. | 2009-08-07 |
| VERIFY 275F GRAVITY INDICATORS (K083643) | STERIS Corporation | 2009-08-07 |
| BOVIE ICON GS ELECTROSURGICAL GENERATOR (GS100), HANDPIECE (GS-OP-R), REUSABLE HANDPIECE CABLE (GS807-RC) (K090586) | Bovie Medical | 2009-08-07 |
| HORIZON XVU (K091165) | Mennen Medical , Ltd. | 2009-08-07 |
| SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET (K091324) | C.R. Bard, Inc. | 2009-08-07 |
| DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5% (K090791) | Century Pharmaceuticals, Inc. | 2009-08-07 |
| TRAILBLAZER SUPPORT CATHETER (K092299) | Ev3, Inc. | 2009-08-07 |
| CDB FLIP-SIDE-CLIP BRACKET (K091702) | Cdb Corporation | 2009-08-07 |
| I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT (K083429) | Weihai Jierui Medical Products Co., Ltd. | 2009-08-07 |
| CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH (K091626) | Cryolife, Inc. | 2009-08-07 |
| EN SNARE ENDOVASCULAR SNARE SYSTEM (K092343) | Merit Medical Systems, Inc. | 2009-08-07 |
| AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A (K091548) | Amco International Manufacturing & Design, Inc. | 2009-08-07 |
| MONOPOLY PEDICLE SCREW SYSTEM (K092073) | Signus Medical | 2009-08-07 |
| CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005 (K092075) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2009-08-07 |
| KOWAGENESIS-DF (K091098) | Kowa Co. , Ltd. | 2009-08-07 |
| SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12 (K092064) | Biosense Webster, Inc. | 2009-08-07 |
| RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL 3.3MM ST (210817) CROSS PIN KITS (K091041) | Depuy Mitek, A Johnson & Johnson Company | 2009-08-07 |
| APPROACH HYDRO ST WIRE GUIDE, MODEL HMW (K091385) | Cook, Inc. | 2009-08-07 |
| TEPHAFLEX SURGICAL FILM (K091633) | Tepha, Inc. | 2009-08-07 |
| FUJINON STERILE OVERTUBES (K091773) | Fujinon, Inc. | 2009-08-07 |
| SIGNAL (K090493) | Zargis Medical Corp. | 2009-08-07 |
| CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES (K091856) | Conmed Corporation | 2009-08-07 |
| PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5 (K092136) | Isoray Medical, Inc. | 2009-08-07 |
| SNAP WOUND CARE DEVICE (DEN080011) | Spiracur, Inc. | 2009-08-07 |
| LAGUNA SIZE 8 PEDICLE SCREW SYSTEM (K091995) | Allez Spine, LLC | 2009-08-07 |
| ECOCEL (K083087) | Polichem S.A | 2009-08-07 |
| EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG) (K083053) | Euroimmun Us, Inc. | 2009-08-07 |
| ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A (K090002) | Baxter Healthcare Corp | 2009-08-07 |
| KOWA, FM-600, MODEL LSS50 (K091039) | Kowa Co. , Ltd. | 2009-08-07 |
| PHARMAPAC PERSONAL LUBRICANT (K091554) | Pharmapac, LLC | 2009-08-07 |
| MONTERIS MEDICAL UFO (K090240) | Monteris Medical, | 2009-08-06 |
| BEYONDIMAGE WORKSTATION (K092235) | Neusoft Medical Systems Co., Ltd. | 2009-08-06 |
| VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM (K091365) | Medtronic Soafamor Danek | 2009-08-06 |
| SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES (K091167) | Shina Corp. | 2009-08-06 |
| IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K091289) | Siemens Healthcare Diagnostics | 2009-08-06 |
| ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087 (K091460) | American Biological Technologies, Inc. | 2009-08-06 |
| MINI TIGHTROPE (K090107) | Arthrex, Inc. | 2009-08-06 |
| ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35 (K090358) | Abbott Laboratories, Inc. | 2009-08-06 |
| I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL (K083603) | Neuro Kinetics | 2009-08-06 |
| MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND (K092079) | Ge Medical Systems Israel, Ultrasound, Ltd. | 2009-08-06 |
| BIPAP SYNCHRONY 2 (K092043) | Respironics, Inc. | 2009-08-05 |
| VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE (K082329) | Viramed Biotech AG | 2009-08-05 |
| OPTILOCK PERIARTICULAR PLATING (K092078) | Biomet Trauma | 2009-08-05 |
| RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581 (K090750) | Restorative Therapies, Inc. | 2009-08-05 |
| CARDO MEDICAL ANTERIOR CERVICAL PLATE SYSTEM (K091396) | Cardo Medical Corp. | 2009-08-05 |
| NURSE'S ASSISTANT O.R. CONTROL SYSTEM ,1.8 (K091648) | Conmed Integrated Systems (Cmis) | 2009-08-05 |
| EZC MEDICAL, LLC INTUBAIDFLEX (K090777) | Ezc Medical, LLC | 2009-08-04 |
| RESTORELLE POLYPROPYLENE MESH (K092207) | Mpathy Medical Devices, Inc. | 2009-08-04 |
| MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730 (K091062) | Gish Biomedical, Inc. | 2009-08-04 |
| LIFECARE ELECTRODES (K083302) | Everyway Medical Instruments Co.,Ltd | 2009-08-03 |
| MODIFICATION TO: DSS STABILIZATION SYSTEM (K091944) | Paradigm Spine, LLC | 2009-08-03 |
| BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732 (K091659) | C.R. Bard, Inc. | 2009-08-03 |
| S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 (K091333) | Alfa Wassermann, Inc. | 2009-08-03 |
| AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM (K083097) | STERIS Corporation | 2009-08-03 |
| QUATTRO LT (K091129) | Resmed, Ltd. | 2009-08-03 |
| ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE (K083707) | Arthrex, Inc. | 2009-08-03 |
| VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES (K091768) | Vision-Sciences, Inc. | 2009-08-03 |