| LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES (K090004) | Levitronix, LLC | 2009-01-15 |
| IMNS MEDACTA NAVIGATION SYSTEM (K083872) | Medacta International S.A. | 2009-01-15 |
| BIOLOX DELTA OPTION CERAMIC HEADS (K082996) | Biomet, Inc. | 2009-01-15 |
| GISH ARTERIAL FILTER WITH HA COATING (K081054) | Gish Biomedical, Inc. | 2009-01-15 |
| G-FORCE TENODESIS SCREW (K083150) | Wrightmedicaltechnologyinc | 2009-01-15 |
| REAL-TIME PCR INTERNAL CONTROL 2B SET (K083430) | Nanogen, Inc. | 2009-01-15 |
| PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT (K082115) | S & C Polymer GmbH | 2009-01-15 |
| MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM (K083537) | Medwaves Incorporated | 2009-01-15 |
| MINNIE SUPPORT CATHETER (K082337) | Vascular Solutions, Inc. | 2009-01-15 |
| A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43 (K082716) | A-Dec, Inc. | 2009-01-15 |
| AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM (K083839) | C.R. Bard, Inc. | 2009-01-15 |
| MODIFICATION TO: METHA HIP SYSTEM (K083495) | Aesculap Implant Systems, Inc. | 2009-01-15 |
| ETHICON ENDO-SURGERY ARTICULATING HOOK KNIFE, MODEL IN4505 (K082955) | Ethicon Endo-Surgery, Inc. | 2009-01-15 |
| TRAUSON GENERAL SPINAL SYSTEM (GSS) (K082617) | Trauson (Jiangsu) Medical Instrument Co., Ltd. | 2009-01-15 |
| NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE (K081911) | Siam Sempermed Corp., Ltd. | 2009-01-15 |
| MIROXI (K081033) | Mir Medical Intl. Research Srl | 2009-01-15 |
| NUVASIVE SURGICAL MESH SYSTEM (K081377) | Nuvasive, Inc. | 2009-01-15 |
| ATRIUM PROLITE S MESH (K082748) | Atrium Medical Corp. | 2009-01-14 |
| SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM (K083025) | Synthes (Usa) | 2009-01-14 |
| DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS (K081378) | Thermo Fisher Scientific | 2009-01-14 |
| SWISSPLANT DENTAL IMPLANT SYSTEM (K081396) | Implant Direct, LLC | 2009-01-14 |
| SPECTRA-SYSTEM ABUTMENTS 2008 (K081101) | Implant Direct, LLC | 2009-01-14 |
| EXPANDABLE PEEK-OPTIMA IMPLANT (K082406) | Ebi, L.P. | 2009-01-14 |
| FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE (K080964) | Fresenius Medical Care North America | 2009-01-14 |
| MODIFICATION TO URESTA PESSARY (K083769) | Eastmed, Inc. | 2009-01-14 |
| LCD3090WQXI OR MD304MC 29.8 INCH DIAGNOSTIC IMAGING LCD MONITOR, MODEL L307TD (K083916) | Nec Display Solutions , Ltd. | 2009-01-14 |
| GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF (K081064) | Ivd Research, Inc. | 2009-01-14 |
| ARTERIAL HEALTH PACKAGE (AHP) SOFTWARE (K083149) | Siemens Medical Solutions USA, Inc. | 2009-01-14 |
| TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS (K072971) | Topcon Medical Systems, Inc. | 2009-01-13 |
| CAPSURE PS SYSTEM (K083743) | Spine Wave, Inc. | 2009-01-13 |
| MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS (K083082) | Moor Instruments, Ltd. | 2009-01-13 |
| INTRATEMP SOLUTION WARMER (K083417) | C Change Surgical, LLC | 2009-01-13 |
| SPECIALTY COILS FOR THE MAGNETOM ESSENZA (K083166) | Siemens Medical Solutions USA, Inc. | 2009-01-13 |
| PHENIX CERVICAL INTERBODY DEVICE (K083167) | Spinal Devices, LLC | 2009-01-13 |
| RESPIFIT S, MODEL RS-LR1001004 (K080299) | Eumedics Medizintechnik Und Marketing GmbH | 2009-01-13 |
| NEWPORT SPINAL SYSTEM (K083089) | Seaspine, Inc. | 2009-01-13 |
| VPAP AUTO WITH HUMIDAIRE 3I (K082605) | Resmed, Ltd. | 2009-01-13 |
| TRAUSON INTRAMEDULLARY NAIL (K081230) | Trauson (Jiangsu) Medical Instrument Co., Ltd. | 2009-01-13 |
| JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE) (K083837) | Pathway Medical Technologies, Inc. | 2009-01-13 |
| FLYING DIAGNOSTIC ULTRASOUND SYSTEM (K083877) | Neusoft Medical Systems Co., Ltd. | 2009-01-13 |
| DIAZYME LP(A) ASSAY (K082488) | General Atomics | 2009-01-13 |
| MD212MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR-L217TG (K083907) | Nec Display Solutions , Ltd. | 2009-01-13 |
| OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120 (K083814) | Cordis Corp., A Johnson & Johnson Co. | 2009-01-13 |
| HD CAMERA HEAD OTV-S7PROH-HD-L08E (K083155) | Olympus Medical Systems Corporation | 2009-01-13 |
| PRUMYX CREAM (K082089) | Prugen, Inc. | 2009-01-13 |
| STINGRAY ELECTROSURGICAL FORCEPS (K083162) | Stingray Surgical Products, Inc. | 2009-01-12 |
| ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 (K082746) | Insightra Medical, Inc. | 2009-01-12 |
| ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE (K082622) | Alma Lasers , Ltd. | 2009-01-12 |
| MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC (K082905) | Medrad, Inc. | 2009-01-12 |
| VITAL SIGNS MONITOR, MODEL: MD500B (K082787) | Beijing Choice Electronic Technololgy Co., Ltd. | 2009-01-12 |
| VOCO PROFLUORID L (K083036) | Voco GmbH | 2009-01-12 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K082936) | Zibo Litong Plastic Products Co., Ltd. | 2009-01-12 |
| ASCENSION SILICONE PIP (K082231) | Ascension Orthopedics, Inc. | 2009-01-12 |
| ASAHI GUIDE WIRE EXTENSION, MODEL AG149000 (K083145) | Asahi Intecc Co., Ltd. | 2009-01-12 |
| OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES (K083240) | Arthrocare Corp. | 2009-01-12 |
| MD21M 21.3 DIAGNOSTIC IMAGING LCD MONITOR, MODEL L218TK (K083332) | Nec Display Solutions , Ltd. | 2009-01-09 |
| BIRTHTRACK (A.K.A. CLM) (K082704) | Barnev, Ltd. | 2009-01-09 |
| ISOLAZ (K083730) | Aesthera Corporation | 2009-01-09 |
| CONFIDANT, MODEL 2.6 (K083331) | Confidant, Inc. | 2009-01-09 |
| REVOLVE STABILIZATION SYSTEM (K083416) | Globus Medical, Inc. | 2009-01-09 |
| IMAGESVR PACS (K082808) | Jaguar Technology Limited | 2009-01-09 |
| REPROCESSED HARMONIC SCALPEL (K083060) | Sterilmed, Inc. | 2009-01-09 |
| FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-4245 (K083664) | Taidoc Technology Corporation | 2009-01-09 |
| XYCOR SPINAL IMPLANT (K082466) | Vertebration,Inc | 2009-01-09 |
| DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML) (K082863) | Dynarex Corporation | 2009-01-09 |
| V60 VENTILATOR, MODEL V8000 (K082660) | Respironics California, Inc. | 2009-01-09 |
| 180W CERELAS D 980NM DIODE LASER, MODEL D180 (K083682) | Biolitec, Inc. | 2009-01-09 |
| PANASIL INITIAL CONTACT AND PANASIL TRAY (K083701) | Kettenbach GmbH & Co. KG | 2009-01-09 |
| SONY UP-DF750 DIGITAL FILM IMAGER (K083522) | Sony Electronics, Inc. | 2009-01-09 |
| ELLEX INNOVATIVE IMAGING EYE CUBED V4 (K083061) | Ellex, Inc. | 2009-01-09 |
| MEDINOL X-SUIT NIR BILIARY METALLIC STENT (K081956) | Medinol, Ltd. | 2009-01-09 |
| MASTERGRAFT RESORBABLE CERAMIC GRANULES (K082917) | Medtronic Sofamor Danek | 2009-01-09 |
| LUBRICANO-ULTRASOUND (K083358) | Farco Pharma GmbH | 2009-01-09 |
| AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1 (K081767) | Amnisure International, LLC | 2009-01-09 |
| KUBTEC XPERT 20 (K083510) | Kub Technologies, Inc. | 2009-01-08 |
| PAIN VISION, MODEL PS-2100 (K072882) | Osachi Co., Ltd. | 2009-01-08 |
| ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS (K081895) | Siemens Medical Solutions Diagnostics | 2009-01-08 |
| WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER (K083274) | Biocompatibles, Inc. | 2009-01-08 |
| RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054 (K080431) | Quantrx Biomedical Corporation | 2009-01-08 |
| MODIFICATION TO ZENIEVA (K083721) | River'S Edge Pharmaceuticals, LLC | 2009-01-08 |
| MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS (K081703) | Entra Health Systems, Ltd. | 2009-01-08 |
| BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215 (K082941) | Biomerix Corporation | 2009-01-07 |
| POWDER FREE BLUE PATIENT NITRILE EXAMINATION GLOVE (K082598) | Tangshan Zhonghong Pulin Group Co., Ltd. | 2009-01-07 |
| A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT (K082827) | A-Dec, Inc. | 2009-01-07 |
| G1B PULSE OXIMETER (K082789) | General Meditech, Inc. | 2009-01-07 |
| PERI-LOC BONE PLATING AND SCREW SYSTEM (K083032) | Smith & Nephew, Inc. | 2009-01-07 |
| VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK (K073618) | STERIS Corporation | 2009-01-07 |
| NEO-VAGINA SURGERY SET AND ACCESSORIES (K071754) | KARL STORZ Endoscopy-America, Inc. | 2009-01-07 |
| REFLEXION HD HIGH-DENSITY MAPPING CATHETER (K080179) | St Jude Medical | 2009-01-07 |
| CALHEALTH, INC., FINGER BLOOD PRESSURE MONITOR, MDMOUSE (K081924) | Calhealth, Inc. | 2009-01-07 |
| VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02 (K081258) | Biosense Webster, Inc. | 2009-01-06 |
| ULTIMA FIVE (K083494) | Pain Management Technologies | 2009-01-06 |
| ENTACT SEPTAL STAPLER, MODEL 610-00100 (K082750) | Entrigue Surgical, Inc. | 2009-01-06 |
| RENEGADE WHEELCHAIR (K082857) | Alpha One | 2009-01-06 |
| IROOT BP, MODEL IRBP 4609 (K082943) | Innovative Bioceramix, Inc. | 2009-01-06 |
| CARDIO VUE QUANTITATIVE ANALYSIS (CVQ) (K082526) | Mri Cardiac Services, Incorporated | 2009-01-05 |
| BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM (K082473) | Bausch & Lomb, Inc. | 2009-01-05 |
| ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS (K081877) | Dutch Ophthalmic Research Center International BV | 2009-01-05 |
| VOCALIS AND VOCALIS SM (K081816) | Cytophil, Inc. | 2009-01-05 |
| VOCALIS GEL (K081815) | Cytophil, Inc. | 2009-01-05 |