| SPECTRA THERAPY SYSTEM A1000 LASER DEVICE (K080689) | Premier Dynamics, Inc. | 2008-07-09 |
| KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES (K081260) | Kimberly-Clark Corp. | 2008-07-09 |
| COMPREHENSIVE REVERSE SHOULDER (K080642) | Biomet, Inc. | 2008-07-09 |
| OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM (K081356) | Mylad Orthopedic Solutions, LLC | 2008-07-09 |
| REPROCESSED ELECTROPHYSIOLOGY CATHETERS (K081329) | Ascent Healthcare Solutions | 2008-07-09 |
| BUSSE PLASTIC LOR SYRINGE (K080804) | Busse Hosipital Disposables | 2008-07-09 |
| NUWAV (K081781) | Laborie Medical Technologies, Corp. | 2008-07-09 |
| SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM (K070779) | Misonix, Inc. | 2008-07-09 |
| MEDTRADE PRODUCTS CELOX HEMOSTATIC GRANULES ON SHEET (K080097) | Medtrade Products , Ltd. | 2008-07-09 |
| CERALAS D 980NM DIODE LASER, MODELS D15 AND D25 (K081015) | Biolitec, Inc. | 2008-07-08 |
| BIRTHTRACK (K080672) | Barnev, Ltd. | 2008-07-08 |
| ACCIN BIPOLAR HEAD SYSTEM (K080647) | Accelerated Innovation, LLC | 2008-07-08 |
| MOSAIC ECO2 LASER SYSTEM (K080496) | Lutronic Corporation | 2008-07-07 |
| LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621 (K081683) | Siemens Healthcare Diagnostics | 2008-07-07 |
| LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT (K081043) | Nxstage Medical, Inc. | 2008-07-07 |
| SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE (KFX-B-200) FIBERFORCE SUTURE (K081598) | Kfx Medical | 2008-07-03 |
| IDEAL LIFE POD (MODEL ILP 0001) (K080538) | Ideal Life, Inc. | 2008-07-03 |
| ZODIC POLYAXIAL SPINAL FIXATION SYSTEM (K081158) | Alphatec Spine, Inc. | 2008-07-03 |
| EVOLVE EPS SYSTEM (K081373) | Wrightmedicaltechnologyinc | 2008-07-03 |
| VIP ANTERIOR CERVICAL PLATE SYSTEM (K081391) | Globus Medical, Inc. | 2008-07-03 |
| SYNGO IMAGING (VERSION V31) (K081734) | Siemens AG Medical Solutions | 2008-07-03 |
| VERTEBRON SSP CERVICAL PLATING SYSTEM (K081567) | Vertebron, Inc. | 2008-07-03 |
| INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT (K073621) | Art Optical Contact Lens, Inc. | 2008-07-03 |
| ONCOBIONIC BIPOLAR ELECTRODE (K080287) | AngioDynamics, Inc. | 2008-07-03 |
| DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692 (K081643) | Siemens Healthcare Diagnostics | 2008-07-03 |
| KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC), ESSENTIAL SOLID (ES) AND ECK (K080224) | SOADCO, S.L. | 2008-07-03 |
| ACTIVE ANTERIOR CERVICAL PLATE SYSTEM (K073500) | Sanacor | 2008-07-03 |
| UNIBLATE ELECTROSURGICAL DEVICE (K080451) | AngioDynamics, Inc. | 2008-07-03 |
| COSTORSOL (K073693) | Preservation Solutions, Inc. | 2008-07-03 |
| COMBI 8 MAX (K070888) | Cec Electronica S.R.L. | 2008-07-03 |
| ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP (K080972) | Ethicon Endo-Sugery, LLC | 2008-07-03 |
| VASCON ROAMER MICROCATHETER (K053310) | Vascon, LLC | 2008-07-03 |
| SYMMETRIC TOTAL KNEE SYSTEM (K080199) | Signal Medical Corporation | 2008-07-03 |
| ELECTRODE ARRAY CAP (K071446) | Electrode Arrays | 2008-07-02 |
| ORTHOBIOM SPINAL SYSTEM (K071668) | Paradigm Spine | 2008-07-02 |
| INTEGRE PRO, MODEL L2RY (K081565) | Ellex Medical Pty, Ltd. | 2008-07-02 |
| KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K080319) | Andon Health Co, Ltd. | 2008-07-02 |
| MYKRES SPINAL SYSTEM (K071074) | Showa Ika Kohgyo Co., Ltd. | 2008-07-02 |
| DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM (K080991) | DePuy Orthopaedics, Inc. | 2008-07-02 |
| CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODEL TD-4237 (K081609) | Taidoc Technology Corporation | 2008-07-02 |
| DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE (K081300) | Siemens Healthcare Diagnostics | 2008-07-02 |
| RELIANCE VBS SYSTEM (K081383) | Reliance Medical Systems, LLC | 2008-07-02 |
| SOLITAIRE ANTERIOR SPINAL SYSTEM (K081501) | Biomet Spine | 2008-07-02 |
| MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM (K081597) | Vertebron, Inc. | 2008-07-02 |
| SPINESMITH CIMPLICITY SPINAL SYSTEM (K080971) | Spine Smith Partners L.P. | 2008-07-02 |
| LAGUNA SIZE 8 PEDICLE SCREW (K072678) | Allez Spine, LLC | 2008-07-02 |
| VU APOD INTERVERTABRAL BODY FUSION DEVICE (K080822) | Theken Spine, LLC | 2008-07-02 |
| NORIAN DRILLABLE (K073303) | Synthes (Usa) | 2008-07-02 |
| WRIST PULSE OXIMETER MD300W (K081125) | Beijing Choice Electronic Technololgy Co., Ltd. | 2008-07-02 |
| SONOACE X6 DIAGNOSTIC ULTRASOUND SYSTEM (K081676) | Medison Co., Ltd. | 2008-07-02 |
| AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101 (K072901) | Amdl, Inc. | 2008-07-01 |
| TLS FIXATION SYSTEM (K080974) | Fournitures Hospitalieres Industrie | 2008-07-01 |
| PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER (K080813) | Radi Medical Systems AB | 2008-07-01 |
| MOBILE I.V. SYSTEMS 10,20,60 (K080695) | Northwind Technologies, Corp. | 2008-07-01 |
| CAPILLARYS URINE (K080916) | Sebia | 2008-07-01 |
| STARCERAM (K081263) | H.C. Starck Ceramics GmbH & Co.Kg | 2008-07-01 |
| SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS (K081205) | Synthes (Usa) | 2008-07-01 |
| STRESSGARD NIGHTGUARD (K072968) | Totalgard Corporation | 2008-07-01 |
| LASER IMAGER DRYPRO MODEL 873 (K081637) | Konica Minolta Medical & Graphic, Inc. | 2008-07-01 |
| FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES (K080915) | Reliant Technologies, Inc. | 2008-07-01 |
| SENSEI CATHETER CONTROL SYSTEM (K073225) | Hansen Medical, Inc. | 2008-06-30 |
| WATCHHALER (K080100) | Activaero America, Inc. | 2008-06-30 |
| CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM LINE EXTENSION (K081564) | Creaspine | 2008-06-30 |
| S-TEST CREATININE (CRE) (K080073) | Alfa Wassermann, Inc. | 2008-06-30 |
| VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 (K081411) | Ortho-Clinical Diagnostics, Inc. | 2008-06-30 |
| APOLLO MINI IPL SYSTEM (K081219) | Sandstone Medical Technologies, LLC | 2008-06-30 |
| KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE) (K081027) | Kimberly-Clark Corp. | 2008-06-30 |
| MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT (K080379) | Micrus Endovascular Corporation | 2008-06-30 |
| L-VARLOCK (K080537) | Kiscomedica S.A. | 2008-06-30 |
| NEB-90 LARGE VOLUME MEDICATION NEBULIZER (K080657) | Medi Nuclear Corp., Inc. | 2008-06-30 |
| DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE MONITORING SYSTEM (K072854) | Tyson Bioresearch, Inc. | 2008-06-30 |
| MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM (K081620) | DePuy Orthopaedics, Inc. | 2008-06-30 |
| HERO, VERSION 2.0 (K081473) | Medical Predictive Science Corp. | 2008-06-27 |
| NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 (K073537) | Siemens Medical Solutions Diagnostics | 2008-06-27 |
| GPS, G SURGICAL PEDICLE SYSTEM (K081041) | G Surgical Co., Ltd. | 2008-06-27 |
| ORQIS EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL BPS-100 (K073631) | Orqis Medical Corporation | 2008-06-27 |
| INTEL HEALTH GUIDE, MODEL: PHS6000 (K080798) | Intel Corp. | 2008-06-27 |
| IDEAL LIFE GLUCO-MANAGER GMM 0001 BLOOD GLUCOSE MONITORING SYSTEM (K080283) | Taidoc Technology Corporation | 2008-06-27 |
| MOUNTAINEER OCT SPINAL SYSTEM (K080828) | Depuy Spine, Inc. | 2008-06-27 |
| MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 (K080679) | Viasys Medsystems | 2008-06-27 |
| TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED (K081555) | Procter & Gamble Co. | 2008-06-27 |
| DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG) (K080497) | Derma Sciences Canada, Inc. | 2008-06-27 |
| PRESSURE INJFECTABLE PICC (K080604) | Arrow International, Inc. | 2008-06-27 |
| ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2940, 1060 (K072182) | Alma Lasers , Ltd. | 2008-06-27 |
| ZEN PROGRAM (MIND 440 HEARING AID) (K080955) | Widex Hearing Aid Co., Inc. | 2008-06-27 |
| MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM (K081542) | Entellus Medical, Inc. | 2008-06-27 |
| FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12 (K081049) | Cryocath Technologies, Inc. | 2008-06-27 |
| MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM (K071984) | Cma Microdialysis AB | 2008-06-27 |
| DORNIER MEDILAS D 30 LASER, MEDILAS D 1064 (K080959) | Dornier Medtech America, Inc. | 2008-06-27 |
| POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES (K080617) | Richard Wolf Medical Instruments Corp. | 2008-06-27 |
| ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES (K073644) | Endogastric Solutions, Inc. | 2008-06-27 |
| MEDTRONIC EXPORT AP CATHETER (K081573) | Medtronic Vascular | 2008-06-27 |
| BIOMET PHOENIX ANKLE NAIL SYSTEM (K081243) | Biomet Trauma | 2008-06-27 |
| MILLENIUM II (K081665) | Next Mobility, LLC | 2008-06-27 |
| PLATELIA LYME IGM (K081362) | Bio-Rad | 2008-06-26 |
| FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT (K080734) | Viasys Healthcare GmbH | 2008-06-26 |
| ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT) (K081146) | Ethicon Endo-Surgery, LLC | 2008-06-26 |
| PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR (K073702) | Lazarus Medical, LLC | 2008-06-26 |
| S-TEST C02 (K073223) | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-26 |
| S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST (K072142) | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-26 |