| PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND 6.5, 7.0 AND 7.5, 8.0 AND 8.5, 9.0 (K081086) | Smiths Medical Asd, Inc. | 2008-08-13 |
| APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 3.0 (K082119) | Toshiba America Medical Systems, In.C | 2008-08-12 |
| ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL (K081745) | Hitachi Medical Systems America, Inc. | 2008-08-12 |
| ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS (K081647) | Xodus Medical, Inc. | 2008-08-12 |
| NEUROCATH AG (K081942) | Vygon Neuro | 2008-08-12 |
| AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER (K080926) | Trudell Medical Intl. | 2008-08-12 |
| OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY (K081939) | Omniguide, Inc. | 2008-08-12 |
| DMC COMPOSITE (K081695) | Kerr Corp. | 2008-08-12 |
| POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS (K080637) | Stereotaxis, Inc. | 2008-08-12 |
| BIOACTIF OSTEOTRANS INTERFENCE SCREW (K081390) | Takiron Co., Ltd. | 2008-08-12 |
| PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS (K081633) | Primed Medical Products, Inc. | 2008-08-11 |
| SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EXTENSION (K082148) | Synthes (Usa) | 2008-08-11 |
| IEC MEDSIGHT AND MEDBRIGHT (K080809) | Innovative Endoscopy Components, LLC | 2008-08-11 |
| WINCO MODEL POWER SERIES LIFT CHAIR (K080533) | Winco, Inc. | 2008-08-11 |
| FORA COMFORTSCAN EAR THERMOMETER, MODELS TD-1261A; TD-1261B (K081445) | Taidoc Technology Corporation | 2008-08-11 |
| ANGIOSCULPT PTA SCORING BALLOON CATHETER (K082059) | Angioscore, Inc. | 2008-08-11 |
| WEBERNEEDLE BASIC LASER (K073352) | Weber Medical GmbH | 2008-08-11 |
| FINDRWIRZ GUIDE WIRE SYSTEM (K080364) | Sentreheart, Inc. | 2008-08-11 |
| POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (PINK, BLACK, GREY, AND BLUE PEPPERMENT) (K081315) | Gx Corporation Sdn Bhd | 2008-08-11 |
| ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495 (K080634) | Beckman Coulter, Inc. | 2008-08-11 |
| INSTRUMED RONGEUR (K081651) | Instrumed International, Inc. | 2008-08-08 |
| MAPERSOL (K080432) | Preservation Solutions, Inc. | 2008-08-08 |
| SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE (K081476) | Surgical Concept Designs | 2008-08-08 |
| ATRILAZE LASER ABLATION SYSTEM (K081457) | Medical Cv, Inc. | 2008-08-08 |
| FDTX GLUCOSE CONTROL SOLUTION (K081915) | Fujirebio Diagnostics Texas, Inc. | 2008-08-08 |
| FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER (K073664) | Injectimed, Inc. | 2008-08-08 |
| HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK BRANDED BPM1 SERIES (K081159) | Harvard Medical Devices , Ltd. | 2008-08-08 |
| PKS OMNI INSTRUMENT (K081766) | Gyrus-Acmi L.P. | 2008-08-08 |
| DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA (K081299) | Siemens Healthcare Diagnostics, Inc. | 2008-08-08 |
| APPROACH CTO WIRE GUIDE (K081337) | Cook Incorporated | 2008-08-08 |
| ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS (K080167) | Siemens Healthcare Diagnostics | 2008-08-08 |
| KINETIX GUIDEWIRE, PLUS GUIDEWIRE (K081021) | Boston Scientific Corp | 2008-08-08 |
| AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION (K080273) | Fujirebio Diagnostics Texas, Inc. | 2008-08-08 |
| LASERPEEL SOFT-MET MODIFIED ERBIUM LASER (K082028) | Global USA Distribution, LLC | 2008-08-08 |
| MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBLE CLINDAMYCIN (K081182) | Siemens | 2008-08-08 |
| EMBLETTA GOLD (K073682) | Embla Systems, Inc. | 2008-08-08 |
| MIRAFLEX HIGH FLOW MICROCATHETER (K080737) | Cook, Inc. | 2008-08-08 |
| DENTAL PORCELAIN (GLASS POWDER), TOP-CERAM T-1, T1, T2, T3, T4 (K081200) | Global Top, Inc. | 2008-08-08 |
| DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER (K080990) | DePuy Orthopaedics, Inc. | 2008-08-08 |
| ANTIMICROBIAL ULTRASITE VALUE, ULTRASITE AG (K073396) | B.Braun Medical, Inc. | 2008-08-07 |
| MODIFICATION TO GFX NERVE ABLATION SYSTEM (K081729) | Bioform Medical, Inc. | 2008-08-07 |
| PROVENT NASAL CANNULA (K080983) | Ventus Medical, Inc. | 2008-08-07 |
| MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS (K080930) | U-System, Inc. | 2008-08-07 |
| TCM ENDO 20 (K081191) | NOUVAG AG | 2008-08-07 |
| NAVIGATOR APPLICATIONS SUITE (K081941) | GE Healthcare Finland Oy | 2008-08-07 |
| ATLAS-BASED AUTOSEGMENTATION (K080799) | Computerized Medical Systems, Inc. | 2008-08-07 |
| SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE (K081051) | Spine View, Inc. | 2008-08-07 |
| OCULAR RESPONSE ANALYZER (K081756) | Reichert, Inc. | 2008-08-07 |
| NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B (K071649) | Wallac OY | 2008-08-07 |
| VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES (K073499) | Zimmer, Inc. | 2008-08-07 |
| APROXI 1100 AND 4000 SERIES DENTAL INLAYS (K073047) | Aproxi Aps | 2008-08-07 |
| METHA SHORT STEM HIP SYSTEM; MODULAR HIP SYSTEM; EXCIA HIP SYSTEM (K081973) | Aesculap Implant Systems, Inc. | 2008-08-07 |
| PEEK-OPTIMA ALIF SPACER (K081636) | Biomet Spine | 2008-08-07 |
| ARCTIC BLAST INTRAVENOUS FLUID CHILLER (K080899) | Medivance, Inc. | 2008-08-07 |
| ALATECH POWDERED LATEX PATIENT EXAMINATION GLOVE (K080606) | Alatech Healthcare, LLC | 2008-08-07 |
| FAMILI OF IRIDEX IQ LASER SYSTEMS (K071687) | Iridex Corp | 2008-08-07 |
| LOVE GUARD MALE LATEX CONDOM (K080833) | Tianjin Human-Care Latex Corporation | 2008-08-07 |
| MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC (K072486) | Hem Con Medical Technologies, Inc. | 2008-08-06 |
| DIGIMATCH ROBODOC SURGICAL SYSTEM (K072629) | Integrated Surgical Systems, Inc. | 2008-08-06 |
| RFVISION, MODEL 9.9D (K080847) | Almana Medical Imaging | 2008-08-06 |
| TRICOS A RESORBABLE SUBSTITUTE (K081721) | Baxter Healthcare Corp | 2008-08-06 |
| ALLTECH ECHOSTAR 1.5 T MR SYSTEM (K082100) | Alltech Medical Systems America, Inc. | 2008-08-06 |
| HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM (K080966) | Aoti , Ltd. | 2008-08-06 |
| TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES (K081232) | Praxim | 2008-08-06 |
| FOSSA URETERAL OPEN STENTS (K072293) | Fossa Medical, Inc. | 2008-08-06 |
| GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 744000 AND DUAL FOOTSWITCH CONNECTOR CABLE, MODEL 710003 (K082054) | Gyrus Acmi, Inc. | 2008-08-06 |
| KETTOSIL AND SILGINAT (K082157) | Kettenbach GmbH & Co. KG | 2008-08-06 |
| EDGE PACS (K081752) | Ashva Technologies, Pvt., Ltd. | 2008-08-06 |
| GE VIVID E9 ULTRASOUND (K081921) | General Electric Co. | 2008-08-06 |
| INOMAX DS (DELIVERY SYSTEM), MODEL 10003 (K080484) | Ino Therapeutics | 2008-08-06 |
| SONIX MDP ULTRASOUND SCANNER (K080935) | Ultrasonix Medical Corporation | 2008-08-06 |
| DERMABIOSAFE (K080298) | Complete Product Resources | 2008-08-05 |
| U-RIGHT TD-4247 BLOOD GLUCOSE MONITORING SYSTEM (K081957) | Taidoc Technology Corporation | 2008-08-05 |
| BIOPRO GO-EZ SCREW (K081149) | Biopro, Inc. | 2008-08-05 |
| PIONEER PLUS CATHETER (K081804) | Medtronic, Inc. | 2008-08-05 |
| MODIFICATION TO LUCENT (K081968) | Spinal Elements, Inc. | 2008-08-05 |
| DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108 (K081992) | Siemens Healthcare Diagnostics, Inc. | 2008-08-05 |
| HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED (K080603) | Te ME NA Sas | 2008-08-05 |
| EZ REGULAR (K080303) | Meinntech Co., Ltd. | 2008-08-05 |
| KYMCO FORU, MODEL EQ35 (K081980) | Besteam Technology, Inc. | 2008-08-04 |
| DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56 (K081319) | Siemens Healthcare Diagnostics, Inc. | 2008-08-04 |
| MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM (K081859) | Sicel Technologies, Inc. | 2008-08-04 |
| PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M (K073381) | Focus Diagnostics, Inc. | 2008-08-04 |
| SELF-ADHESIVE ELECTRODES (K080276) | Cathay Health Care Equipment Manufacturing, Inc. | 2008-08-04 |
| TIGER CANNULATED SCREW SYSTEM (K081510) | Trilliant Surgical, Ltd. | 2008-08-04 |
| V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE (K081289) | Baxter Healthcare Corp | 2008-08-04 |
| TEMPLATE AND COUNTER-FIT (K081017) | Clinician'S Choice Dental Products, Inc. | 2008-08-04 |
| RADIANCE (K080749) | American Orthodontics | 2008-08-04 |
| INTERCEPTOR PLUS CORONARY FILTER SYSTEMS (K073523) | Medtronic, Inc. | 2008-08-01 |
| MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 (K082045) | Spacelabs Medical, Inc. | 2008-08-01 |
| MODIFICATION TO ZILVER 635 BILIARY STENT (K080037) | Cook, Inc. | 2008-08-01 |
| SCANSCOPE XT SYSTEM (K073677) | Aperio Technologies | 2008-08-01 |
| CARRIAZO-PENDULAR MICROKERATOME (K082043) | Schwind Eye-Tech-Solutions GmbH & Co. KG | 2008-08-01 |
| FIATLUX VISUALIZE (K082041) | Fiatlux Imaging, Inc. | 2008-08-01 |
| OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING (K081876) | Osteomed LP | 2008-08-01 |
| DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253 (K073112) | Intuitive Surgical, Inc. | 2008-08-01 |
| STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS (K081085) | Senorx, Inc. | 2008-08-01 |
| APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES (K082031) | Appasamy Associates | 2008-07-31 |
| STATMAP, MODEL 7200 (K072109) | Ramsey Medical, Inc. | 2008-07-31 |
| SKYLINE 55 (K081552) | Larsen & Toubro Limited | 2008-07-31 |