| THERAKNIT GARMENT ELECTRODE (K053214) | Neurotron Medical | 2005-12-20 |
| AMBU MARK IV BABY RESUSCITATOR (K053142) | Ambu A/S | 2005-12-20 |
| GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER (K053245) | Uresil, LLC | 2005-12-20 |
| SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM (K052810) | Scandius Biomedical, Inc. | 2005-12-20 |
| VITROS CA 19-9 (K052889) | Fujirebio Diagnostics,Inc. | 2005-12-20 |
| KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES (K053262) | KARL STORZ Endoscopy-America, Inc. | 2005-12-19 |
| ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM (K052906) | Zimmer, Inc. | 2005-12-19 |
| SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH (K053066) | Genzyme Corporation | 2005-12-19 |
| ESTECH COBRA BIPOLAR SYSTEM (K053100) | Endoscopic Technologies, Inc. | 2005-12-19 |
| REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA (K052081) | Estech, Inc. | 2005-12-16 |
| MASTERGRAFT PUTTY BONE VOID FILLER (K051386) | Medtronic Vascular | 2005-12-16 |
| MULTIPLE (TOOTH DESENSITIZER) (K052263) | Cosmedent, Inc. | 2005-12-16 |
| BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20 (K052646) | Biospace Corporation Limited | 2005-12-16 |
| IGI-SYSTEM (K052840) | Denx Advanced Dental Systems | 2005-12-16 |
| BREATHEX OMEGA CPAP DEVICE, MODEL 322 (K052597) | Hoffman Laboratories, LLC | 2005-12-16 |
| GRAFTCAGE TLX (K051781) | Osteotech, Inc. | 2005-12-16 |
| FC 700 FETAL MONITOR (K043597) | Bionet Co., Ltd. | 2005-12-16 |
| GRAFTON DBM (K051195) | Osteotech, Inc. | 2005-12-16 |
| ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. (K052694) | Ind Diagnostic, Inc. | 2005-12-16 |
| STRYKER CUSTOM TI IMPLANT (K052871) | Stryker Leibinger | 2005-12-16 |
| C2000 AUTOMATED MANIFOLD KIT (K052744) | Acist Medical Systems, Inc. | 2005-12-16 |
| STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H74939031-XXXXXX (K053118) | Boston Scientific Corp | 2005-12-16 |
| FC 1400 FETAL MONITOR (K043598) | Bionet Co., Ltd. | 2005-12-16 |
| STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX (K053116) | Boston Scientific Corp | 2005-12-16 |
| ARCHITECT B12 CALIBRATORS (K053330) | Abbott Laboratories | 2005-12-16 |
| READMYHEART, MODEL RMH2.0 (K052303) | Dailycare Biomedical, Inc. | 2005-12-16 |
| B-CARE POWDERED LATEX EXAMINATION GLOVES (K052845) | B-Care Industries Co., Ltd. | 2005-12-16 |
| ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.) (K052160) | Welch Allyn, Inc. | 2005-12-16 |
| LUMIMED MONOCHROME LCD MONITOR, MODELS MM 20, MM 30 AND MM50 (K052120) | Heeyoung Co., Ltd. | 2005-12-16 |
| ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE) (K052007) | Horiba Abx | 2005-12-16 |
| ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) (K053196) | Inverness Medical Innovations, Inc. | 2005-12-16 |
| GE VOLUSON I (K053435) | General Electric Co. | 2005-12-16 |
| WARMING LIQUID PERSONAL LUBRICANT (K052974) | Pharmapac, LLC | 2005-12-16 |
| MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM (K053154) | Pie Medical | 2005-12-16 |
| STARLITE 2006 (K052604) | Laser Dental Innovations | 2005-12-16 |
| MODEL 750E SERIES MONITOR (K051896) | Cas Medical Systems, Inc. | 2005-12-16 |
| 3M TEGADERM SILVER (AG) MESH (K053256) | 3M Company | 2005-12-16 |
| U-CLIP DEVICE, MODELS B140, B160 AND B180 (K053252) | Medtronic Vascular | 2005-12-16 |
| STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM (K052990) | Biomet, Inc. | 2005-12-16 |
| MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM (K052799) | Bonutti Research, Inc. | 2005-12-16 |
| MEDTRONIC M2 MAGNET ADJUSTMENT TOOL (K052386) | Medtronic Neurosurgery | 2005-12-16 |
| DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR (K053090) | Beckman Coulter, Inc. | 2005-12-16 |
| ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350 (K052727) | Rossmax International , Ltd. | 2005-12-16 |
| BEAMER PAINLOW INFRARED LIGHT TREATMENT SYSTEM (K052307) | Beamline Corporation | 2005-12-16 |
| NIPRO SUREFUSER AMBULATORY INFUSION PUMP (K051828) | Nipro Medical Corporation | 2005-12-15 |
| VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE (K052632) | Vital Images, Inc. | 2005-12-15 |
| DS CASSETTE (K053173) | Konica Minolta Medical & Graphic, Inc. | 2005-12-15 |
| FUTURABOND NR SINGLE DOSE (K053392) | Voco GmbH | 2005-12-15 |
| MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENS (K052606) | Marietta Vision | 2005-12-15 |
| DDRFORMULA AND DDRFORMULA PLUS (K052943) | Swissray Medical AG | 2005-12-15 |
| I-STAT CREATINE KINASE MB (CK-MB) (K051433) | I-Stat Corporation | 2005-12-15 |
| YUSHENG DISPOSABLE VAGINAL SPECULUM (K052912) | Zhejiang Yusheng Medical Instrument Co. , Ltd. | 2005-12-15 |
| SOLAR GI (K052338) | Medical Measurement Systems B.V. | 2005-12-15 |
| ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT (K053250) | Advanced Neuromodulation Systems | 2005-12-15 |
| TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION (K053197) | Cordis Neurovascular, Inc. | 2005-12-15 |
| MENTOR ARIS SUPRAPUBIC SURGICAL KIT (K053296) | Mentor Corporation | 2005-12-15 |
| PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20 (K053011) | Bio Protech, Inc. | 2005-12-14 |
| ISE INDIRECT NA, K, CL FOR GEN.2 (K053165) | Roche Diagnostics Corp. | 2005-12-14 |
| FU HONG INDUSTRIES LIMITED SOOTHER TEETHER (K052531) | Fu Hong Industries , Ltd. | 2005-12-14 |
| DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 40406 (K052259) | Schering-Plough Healthcare Products, Inc. | 2005-12-14 |
| VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873; (K052645) | Ortho-Clinical Diagnostics | 2005-12-14 |
| SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT (K053199) | Synthes (Usa) | 2005-12-14 |
| NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800 (K053141) | The Magstim Company , Ltd. | 2005-12-14 |
| TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM (K052503) | Bayer Healthcare, LLC | 2005-12-14 |
| TECO ISE REAGENT SET FOR CX SYSTEM (K052724) | Teco Diagnostics | 2005-12-14 |
| VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN (K053097) | bioMerieux, Inc. | 2005-12-14 |
| NEXA BONE SCREW SYSTEM (K053394) | Nexa Orthopedics, Inc. | 2005-12-14 |
| BREATHING FILTER BACTERIAL/VIRAL, MODEL AG7178 (K052087) | Ag Industries | 2005-12-14 |
| QUICKVUE INFLUENZA A + B TEST (K053146) | Quidel Corp. | 2005-12-14 |
| STAYHEALTHY BODY COMPOSITION ANALYZER, MODELS BC1 AND BC2 (K052522) | Stayhealthy, Inc. | 2005-12-13 |
| STARDUST II (K052573) | Respironics, Inc. | 2005-12-13 |
| TEH LOONG POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW (K052635) | Teh Loong Corp. | 2005-12-13 |
| LMA FASTRACH ETT SINGLE USE (K051993) | The Laryngeal Mask Co., Ltd. | 2005-12-13 |
| TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD (K052776) | Arthrex, Inc. | 2005-12-13 |
| MODIFICATION TO THERMAGE THERMACOOL SYSTEM (K053365) | Thermage, Inc. | 2005-12-13 |
| DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE (K052289) | Biowave Corporation | 2005-12-13 |
| VASCULAR SOLUTIONS SKYWAY SUPPORT CATHETER (K052258) | Vascular Solutions, Inc. | 2005-12-13 |
| ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP (K053282) | Pajunk GmbH | 2005-12-13 |
| COROLENE (K052701) | Peters Surgical | 2005-12-13 |
| SPIRO-BALL (K053149) | Leventon, S.A. | 2005-12-13 |
| OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER (K052866) | Oxyheal Health Group | 2005-12-13 |
| PRO-FLOW MULTIPURPOSE CANNULA (K053063) | Pro-Tech Services, Inc. | 2005-12-13 |
| WINNER SELF SEAL STERILIZATION POUCH (K051242) | Winner Medical (Usa), Inc. | 2005-12-13 |
| TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM (K052233) | Etview , Ltd. | 2005-12-13 |
| ARTHREX TENSIONLOK (K052901) | Arthrex, Inc. | 2005-12-12 |
| T-TEK (K050817) | R2 Diagnostics, Inc. | 2005-12-12 |
| ORTHOFIX TITANIUM NAILING SYSTEMS (K053261) | Orthofix Srl | 2005-12-12 |
| NUVASIVE COROENT EXTENSURE SYSTEM (K052210) | Nuvasive, Inc. | 2005-12-12 |
| ELLIPSE FLEX PPT, MODEL 9ESF7255 (K052688) | Danish Dermatologic Development A/S | 2005-12-12 |
| IMMUNOSCAN RA ANTI-CCP TEST SYSTEM (K052133) | Eurodiagnostica | 2005-12-12 |
| CAPLESS PEDICLE SCREW SYSTEM (K052847) | X-Spine Systems, Inc. | 2005-12-12 |
| LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP (K051926) | Limerick, Inc. | 2005-12-12 |
| EASYSTIM NMS-28 (K050921) | Easy Med Instrument Co., Ltd. | 2005-12-12 |
| DEXTROSCOPE & DEXTROBEAM (K053162) | Volume Interactions Pte, Ltd. | 2005-12-09 |
| EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER (K053258) | Hitachi Medical Corp. | 2005-12-09 |
| MEDISIZE GOLD (K052615) | Medisize BV | 2005-12-09 |
| DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM (K052340) | Alfa Tech Medical Systems, Ltd. | 2005-12-09 |
| FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300 (K050933) | Medisurg , Ltd. | 2005-12-09 |
| HOFFMANN II ROD TO WIRE COUPLING (K053349) | Howmedica Osteonics Corp. | 2005-12-09 |
| BREATHKEY MODEL G10/BREATHKEY MODEL G30X (K052804) | Omega Point Systems, LLC | 2005-12-09 |