| BEAMAX (K063249) | Medic Sharplight , Ltd. | 2007-01-17 |
| VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES (K063396) | Lasering S.R.L. | 2007-01-17 |
| BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM (K062363) | B&W Tek, Inc. | 2007-01-17 |
| C-JAWS CERVICAL COMPRESSIVE MINI FRAME (K062181) | Medicrea Technologies | 2007-01-16 |
| EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM (K062775) | Ortho Development Corp. | 2007-01-16 |
| SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE (K063688) | The Anspach Effort, Inc. | 2007-01-16 |
| U2 HIP STEM, TI PLASMA SPRAY (K062978) | United Orthopedic Corp. | 2007-01-16 |
| LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES (K063052) | Walter Lorenz Surgical, Inc. | 2007-01-12 |
| MERON PLUS (K063554) | Voco GmbH | 2007-01-12 |
| NEATSTITCH NEATCLOSE SUTURING DEVICE (K063462) | Neat Stitch , Ltd. | 2007-01-12 |
| NIPRO SAFETOUCH II GAMMA (K063721) | Nipro Medical Corp. | 2007-01-12 |
| PRORHYTHM PROMAP COAXIAL MAPPING CATHETER, MODELS PRI-MAP-15, PRI-MAP-20, PRI-MAP-25 (K061678) | Prorhythm | 2007-01-12 |
| VERTIFLEX SPINAL SCREW SYSTEM (K062670) | Vertiflex (Tm), Incorporated | 2007-01-12 |
| QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS (K062966) | Seradyn, Inc. | 2007-01-12 |
| CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY (K063370) | Arthrosurface, Inc. | 2007-01-12 |
| LOCOBASE WOUND AND SKIN EMULSION (K060272) | Ferndale Laboratories, Inc. | 2007-01-12 |
| POWER EXTENDERS MODEL# PEC200, PES200,PES200S (K063746) | Power Medical Interventions, Inc. | 2007-01-12 |
| SYNGO MI APPLICATIONS 2007A (K063826) | Siemens Medical Solutions USA, Inc. | 2007-01-12 |
| VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL) (K063217) | B.Braun Medical, Inc. | 2007-01-12 |
| DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES (K062996) | Axon Systems, Inc. | 2007-01-12 |
| TENDER FIBER (K063170) | Micerium S.P.A. | 2007-01-12 |
| SPY IMAGING SYSTEM (K063345) | Novadaq Technologies, Inc. | 2007-01-12 |
| SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR (K061430) | Custom Ultrasonics | 2007-01-12 |
| LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 (K063409) | Agamatrix | 2007-01-12 |
| INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A (K063747) | Inovel, LLC | 2007-01-12 |
| CLEVER CHEK TD-3213/ CLEVER CHEK TD-3215/ DR. T TD-3216/ CLEVER CHEK TD-3217/ CLEVER CHEK TD-3250 BLOOD GLUCOSE PLUS BLO (K062800) | Taidoc Technology Corporation | 2007-01-12 |
| PORTLAND COBALT CHROME FEMORAL HEAD (K063278) | Portland Orthopaedics Limited | 2007-01-12 |
| RELIANCE CI PROCESS INDICATOR (K063285) | Albert Browne , Ltd. | 2007-01-12 |
| PARAMOUNT VBR SYSTEM (K062759) | Innovative Spinal Technologies, Inc. | 2007-01-12 |
| ACL TOP (K063679) | Instrumentation Laboratory CO | 2007-01-12 |
| EASYGLUCO, MODEL IGM-0002 G2 (K061431) | U. S. Diagnostics, Inc. | 2007-01-12 |
| STRAUMANN PREFGEL (K063812) | Straumann USA | 2007-01-12 |
| TRU-CABLE (K063309) | Truphatek International, Ltd. | 2007-01-12 |
| PAJUNKS STIMULONG TSUI-METHOD SET (K062900) | PAJUNK GmbH Medizintechnologie | 2007-01-12 |
| HEARTSTART MRX, MODELS M3535A OR M3536A (K063375) | Philips Medical Systems | 2007-01-11 |
| CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM (K063644) | Cardica, Inc. | 2007-01-11 |
| VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE (K063623) | bioMerieux, Inc. | 2007-01-11 |
| PORTABLE X-RAY SYSTEM, MODEL PORT-X II (K063121) | Genoray Co., Ltd. | 2007-01-11 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTAZIDIME (GN) 0.5-64 UG/ML (K063573) | Becton, Dickinson & CO | 2007-01-11 |
| DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH (K063610) | Dade Behring, Inc. | 2007-01-11 |
| D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED (K063255) | Sorin Group Italia S.R.L. | 2007-01-11 |
| VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) (K061613) | Tripath Imaging | 2007-01-10 |
| SPI ELEMENT PLATFORM O 4.0 MM (K070007) | Thommen Medical AG | 2007-01-10 |
| RELIEF ACP ORAL CARE GEL (K062176) | Discus Dental, Inc. | 2007-01-10 |
| INSUFLOW DEVICE, MODEL 6198 (K063546) | Lexion Medical, LLC | 2007-01-10 |
| XODUS MEDICAL ANTI-FOG SOLUTION (K063587) | Xodus Medical, Inc. | 2007-01-09 |
| ALEXIS WOUND RETRACTOR (K062907) | Applied Medical Resources | 2007-01-09 |
| SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM (K063456) | Topex, Inc. | 2007-01-09 |
| HUMAPEN LUXURA HD (K063151) | Eli Lilly and Co. | 2007-01-09 |
| AG-EDGE, MODEL 91200 (K063103) | Medel S.P.A. | 2007-01-08 |
| POWERTONE, MODEL PT-11 (K062439) | Johari Digital Healthcare , Ltd. | 2007-01-08 |
| SIMPLEX P BONE CEMENT (K062553) | Stryker Orthopaedics | 2007-01-08 |
| REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM (K063405) | Radiant Medical | 2007-01-08 |
| TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU (K062937) | Baylis Medical Co., Inc. | 2007-01-08 |
| ENCORE KNEE SYSTEM IFU (K063406) | Encore Medical L.P. | 2007-01-08 |
| DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM (K063525) | Datascope Corp. | 2007-01-05 |
| CLICKZIP, MODEL U-100 INSULIN SAFETY SYRINGE (K062780) | Medical Device Manufacturer (Thailand) , Ltd. | 2007-01-05 |
| SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM (K063181) | Synthes (Usa) | 2007-01-05 |
| MODIFICATION TO: SATELLITE SPINAL SYSTEM (K060415) | Medtronic Sofamor Danek | 2007-01-05 |
| SFB AND CFB IMPLANTS - 5.0 PLATFORM (K063718) | Nobel Biocare AB | 2007-01-05 |
| PENCURE, MODEL VL-7 (K063529) | J. Morita USA, Inc. | 2007-01-05 |
| SYNGO CIRCULATION SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY (K063762) | Siemens AG Medical Solutions | 2007-01-05 |
| HILGER DUAL-STIM NERVE STIMULATOR (K063560) | Wr Medical Electronics Co. | 2007-01-05 |
| AYCAN WORKSTATION OSIRIX (K063470) | Aycan Digitalsysteme GmbH | 2007-01-05 |
| STEAMPLUS STEAM INTEGRATOR (K063799) | Spsmedical Supply Corp. | 2007-01-05 |
| FUSION QUATTRO EXTRACTION BALLOON XL (K063677) | Wilson-Cook Medical, Inc. | 2007-01-05 |
| X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER (K063632) | C.R. Bard, Inc. | 2007-01-05 |
| PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE (K063781) | Philips Medical Systems North America Co. | 2007-01-05 |
| VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS (K062165) | Ortho-Clinical Diagnostics | 2007-01-05 |
| ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM (K063803) | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007-01-05 |
| INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900 THROUGH 7905 (K062627) | Vascular Solutions, Inc. | 2007-01-05 |
| ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5 (K063559) | Philips Medical Systems | 2007-01-04 |
| DEPUY PEAK FX HIP PLATE (K063509) | DePuy Orthopaedics, Inc. | 2007-01-04 |
| GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES (K062675) | Gemore Technology Co, Ltd. | 2007-01-04 |
| GAMBRO POSICLEAR (K061782) | Gambro Services, Inc. | 2007-01-04 |
| HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER (K063338) | Mimosa Acoustics, Inc. | 2007-01-04 |
| IKONISCOPE ONCOFISH BLADDER TEST SYSTEM (K062755) | Ikonisys, Inc. | 2007-01-04 |
| TS-BONE HIP TOOL (K063709) | Orthopedic Sciences, Inc. | 2007-01-04 |
| ACUSON P10 DIAGNOSTIC ULTRASOUND SYSTEM (K063761) | Siemens Medical Solutions USA, Inc. | 2007-01-04 |
| V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD0600 (K062896) | Sanarus Medical, Inc. | 2007-01-03 |
| LAPMAN LAPAROSCOPE MANIPULATOR AND ACCESSORIES, MODEL 900-200 SERIES (K062968) | Medsys, S.A. | 2007-01-03 |
| AR1000 ULTRASONIC WOUND THERAPY SYSTEM (K062544) | Arobella Medical, LLC | 2007-01-03 |
| APEXNRG XFR (K063843) | Medicnrg , Ltd. | 2007-01-03 |
| ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS (K063058) | Arthrex, Inc. | 2007-01-03 |
| BIOTOP HOOKSAFE U-100 INSULIN SYRINGE, MODELS 0.5CC/ML AND 1CC/ML (K062318) | Biotop Technology Co., Ltd. | 2007-01-03 |
| BONART ART-L3 LED CURING LIGHT (K062289) | Bonart Co., Ltd. | 2007-01-03 |
| LIFECELL DURAL SUBSTITUTE MATRIX (K061208) | Lifecell Corp. | 2007-01-03 |