| ULTRASONIC NEBULIZER SYSTEM, MODEL HL100 (K081738) | Health & Life Co., Ltd. | 2008-09-17 |
| CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2 (K082107) | Cliniqa Corporation | 2008-09-17 |
| INVENTUS IMPLANT SYSTEM (K081579) | Inventus Co., Ltd. | 2008-09-17 |
| ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-A (K082542) | Cardicare Company, Ltd. | 2008-09-17 |
| INFRARED EAR THERMOMETER, MODEL ET-101A (K082192) | Sejoy Electronics & Instruments Co., Ltd. | 2008-09-17 |
| CLARO (K080638) | Clrs Technology Corporation | 2008-09-17 |
| MASTERGRAFT PUTTY (K081784) | Medtronic Sofamor Danek | 2008-09-17 |
| SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS (K081613) | American Medical Systems, Inc. | 2008-09-17 |
| NON-STERILE, POWDERED LATEX EXAMINATION GLOVE (K081910) | Siam Sempermed Corp., Ltd. | 2008-09-17 |
| MATRIX RF APPLICATOR (K073572) | Syneron Medical, Ltd. | 2008-09-17 |
| PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS (K082516) | Smith & Nephew, Inc. | 2008-09-17 |
| EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005 (K082121) | Eps Bio Technology Corp. | 2008-09-17 |
| SILVERMED ANTIMICROBIAL SILVER HYDROGEL (K073019) | Argentis Biomedical Incorporated | 2008-09-16 |
| EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2 (K082279) | St Jude Medical | 2008-09-16 |
| OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM (K082270) | Vertiflex, Inc. | 2008-09-16 |
| G-2 V5 (K081117) | Vitrolife Sweden AB | 2008-09-16 |
| MODIFICATION TO AURORA MRI SYSTEM (K073425) | Aurora Imaging Technology, Inc. | 2008-09-16 |
| G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8 (K071132) | Tosoh Bioscience, Inc. | 2008-09-16 |
| REPROCESSED ELECTROPHYSIOLOGY CATHETERS (K082023) | Ascent Healthcare Solutions | 2008-09-16 |
| INREACH PLANNING LAPTOP (K082386) | Superdimension, Ltd. | 2008-09-16 |
| G-1 V5 (K081114) | Vitrolife Sweden AB | 2008-09-16 |
| SUPRAMESH EXTRA (K080216) | S. Jackson, Inc. | 2008-09-15 |
| BLACKSTONE PEDICLE SCREW SYSTEM (K081684) | Blackstone Medical, Inc. | 2008-09-15 |
| PTFE INTERLOCK PEELABLE INTRODUCERS (K081394) | Enpath Medical, Inc. | 2008-09-15 |
| 21.3-INCH (54CM) MONOCHROME LCD MONITOR MS21I2 (MDL2127A) (K081945) | Totoku Electric Co., Ltd. | 2008-09-12 |
| MODIFICATION TO CAPSTONE SPINAL SYSTEM (K082342) | Medtronic Sofamor Danek | 2008-09-12 |
| SLEEPSTYLE 200 AUTO SERIES HC254 (K081029) | Fisher & Paykel Healthcare, Ltd. | 2008-09-12 |
| SAVE RESUSCITATOR (K073410) | Artivent Corporation | 2008-09-12 |
| BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES (K081440) | Smiths Medical Asd, Inc. | 2008-09-12 |
| PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM) (K082312) | Heartscape Technologies, Ltd. | 2008-09-12 |
| ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32 (K080470) | Maquet Cardiopulmonary, AG | 2008-09-12 |
| NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS (K081778) | Instrumentation Industries, Inc. | 2008-09-12 |
| CONTURA LUMEN MARKER (K082264) | Senorx, Inc. | 2008-09-12 |
| FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700 (K081712) | Guangdong Biolight Meditech Co., Ltd. | 2008-09-12 |
| FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK (K080209) | Fisher & Paykel Healthcare, Ltd. | 2008-09-12 |
| DENJECTOR (K081694) | Dxm Co., Ltd. | 2008-09-12 |
| DRAD3000E/RADREX-I (K082494) | Toshiba America Medical Systems, In.C | 2008-09-12 |
| CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, 2020TC SPECT IMAGING SYSTEM (K082368) | Digirad Corp. | 2008-09-12 |
| SIMPACT IMPLANT SYSTEM (K081226) | Simpact, LLC | 2008-09-12 |
| YEAST TRAFFIC LIGHT PNA FISH (K080719) | Advandx, Inc. | 2008-09-12 |
| KEGEL8 PELVIC EXERCISER, MODEL OPH 400 (K081480) | Ne Services , Ltd. | 2008-09-12 |
| ACCELAWAVE SYSTEM (K082484) | Genesis Biosystems, Inc. | 2008-09-12 |
| DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS (K081569) | Dynarex Corporation | 2008-09-12 |
| TRUFILL DCS SYRINGE (K082324) | Cordis Neurovascular, Inc. | 2008-09-12 |
| NEOSALUS (K070309) | Quinnova Pharmaceuticals | 2008-09-12 |
| STARLIGHT (K081994) | Orthomerica Products, Inc. | 2008-09-12 |
| SOLX 790 TITANIUM SAPPHIRE LASER (K081774) | Solx, Inc. | 2008-09-12 |
| QUANTRA (K082483) | Hologic, Inc. | 2008-09-12 |
| ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H (K081276) | Horiba Abx | 2008-09-12 |
| ACTIFUSE FLOW BONE GRAFT SUBSTITUTE (K082073) | Apatech , Ltd. | 2008-09-11 |
| ARCHITECT CYCLOSPORINE (K080751) | Fujirebio Diagnostics,Inc. | 2008-09-11 |
| NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS (K081693) | Instrumentation Industries, Inc. | 2008-09-11 |
| EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT (K082307) | Evenflo Company, Inc. | 2008-09-11 |
| ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR (K071455) | Siemens Medical Solutions Diagnostics | 2008-09-11 |
| SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS (K081704) | Lumenis, Inc. | 2008-09-11 |
| HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE (K080682) | Handpiece Headquarters, Inc. - Hpr, Inc. | 2008-09-11 |
| EFFECTIV (TM) CAP (K080579) | Hospira, Inc. | 2008-09-11 |
| HLM TUBING SET WITH BIOLINE COATING (K080592) | Maquet Cardiopulmonary, AG | 2008-09-11 |
| EYEFEEL OPHTHALMIC WARMER (K082087) | Bio-Lipid, Inc. | 2008-09-11 |
| VASCUTRAK 2, MODELS: V14 AND V18 (K082343) | Ymed, Inc. | 2008-09-11 |
| ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01 (K080696) | Abbott Laboratories | 2008-09-11 |
| ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP (K081338) | Roche Diagnostics | 2008-09-11 |
| EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (K081523) | Abbott Vascular-Vascular Solutions | 2008-09-11 |
| LUCENT MAGNUM+ (K081711) | Spinal Elements, Inc. | 2008-09-11 |
| RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110 (K081450) | Bionime Corporation | 2008-09-11 |
| ENSITE FUSION DYNAMIC REGISTRATION TOOL (K082467) | St Jude Medical | 2008-09-11 |
| PARKONE (K073508) | Oculus Optikgerate GmbH | 2008-09-11 |
| CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS (K082393) | Unilens Corp., USA | 2008-09-11 |
| BEAMER ARGON PROBE (K081644) | Conmed Corporation | 2008-09-10 |
| UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM (K082273) | Depuy Spine, Inc. | 2008-09-10 |
| ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213 (K082156) | Teleflex Medical | 2008-09-10 |
| DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR (K081789) | Siemens Healthcare Diagnostics, Inc. | 2008-09-10 |
| EXPEDIUM SPINE SYSTEM (K081898) | Depuy Spine, Inc. | 2008-09-10 |
| VISUALASE THERMAL THERAPY SYSTEM (K081656) | Biotex, Inc. | 2008-09-10 |
| MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS (K080775) | Tosama D.D. | 2008-09-10 |
| PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER (K081557) | Jddb Manufacturing, Inc. | 2008-09-10 |
| SURGVIEW INTEGRATED VISUALIZATION SYSTEM (K082293) | Biovision Technologies, LLC | 2008-09-09 |
| CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA (K073328) | Paieon, Inc. | 2008-09-09 |
| MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A (K082485) | Neusoft Medical Systems Co., Ltd. | 2008-09-09 |
| EA STIMULATOR (K080221) | Helio Medical Supplies, Inc. | 2008-09-09 |
| UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM (K081919) | Fukuda Denshi Co., Ltd. | 2008-09-09 |
| DIGNITY 100 (K082246) | Dignity Medical Devices, Inc. | 2008-09-09 |
| PASCAL SYNTHESIS DELIVERY SYSTEM (K081744) | Optimedica Corporation | 2008-09-09 |
| AUDICOR, HEMO AMBULATORY MONITOR (K073545) | Inovise Medical, Inc. | 2008-09-09 |
| VERSAPOD (TM) INSTRUMENT TRAYS (K071783) | Containmed, Inc. | 2008-09-09 |
| RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L (K081659) | Masimo Corporation | 2008-09-09 |
| METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD (K082146) | Aesculap Implant Systems, Inc. | 2008-09-09 |
| GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72 (K080776) | Us Ophthalmic, LLC | 2008-09-09 |
| CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE (K081374) | Wrightmedicaltechnologyinc | 2008-09-09 |
| PACSMATE MMD-3213M MONITOR (K082496) | Iei Technology Corp. | 2008-09-09 |
| COMPUMEDICS NEUVO (K081151) | Compumedics USA, Ltd. | 2008-09-08 |
| BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC (K081547) | Bio-Med USA, Inc. | 2008-09-08 |
| TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM (K080116) | Transonic Systems, Inc. | 2008-09-08 |
| SYNTHES RIB FIXATION SYSTEM (K081623) | Synthes (Usa) | 2008-09-08 |
| PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT (K082560) | Kettenbach GmbH & Co. KG | 2008-09-08 |
| LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK (K082036) | Bio-Rad Laboratories | 2008-09-08 |
| WEIGAO EMPTY CARTRIDGE SYRINGE (K081241) | Shandong Weigao Group Medical Polymer Co., Ltd. | 2008-09-08 |
| MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN (K081013) | Siemens Healthcare Diagnostics | 2008-09-08 |
| CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY (K080531) | Conmed Linvatec | 2008-09-05 |
| ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRAIGHT LUMBAR CAGES (K081614) | Interbody Innovations, Llp | 2008-09-05 |