| COLLAGEN BONE HEALING PROTECTIVE SHEET (K052041) | Collagen Matrix, Inc. | 2005-10-25 |
| GYRUS PLASMACISION AND PLASMABLEND ELECTRODES (K050460) | Gyrus Medical, Inc. | 2005-10-25 |
| TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470 (K051587) | Tracoe Medical GmbH | 2005-10-25 |
| AQUAMANTYS PUMP GENERATOR SYSTEM (K052859) | Tissuelink Medical, Inc. | 2005-10-25 |
| ARCHITECT CA 19-9XR ASSAY (K052000) | Fujirebio Diagnostics,Inc. | 2005-10-25 |
| SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM (K052361) | Nucletron Corporation | 2005-10-24 |
| IRRADIA MID - LASER (S3) (K051548) | Irradia AB | 2005-10-24 |
| ALUMA SKIN RENEWAL SYSTEM (K051214) | Lumenis, Inc. | 2005-10-24 |
| INOGEN SATELLITE CONSERVER, MODEL SC-100 (K052563) | Medical Electronic Devices, Inc. | 2005-10-24 |
| SHOULDER NAIL PLATE (K052294) | Hand Innovations, LLC | 2005-10-21 |
| IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS (K051579) | Immunalysis Corporation | 2005-10-21 |
| MODUS IMF SCREWS 2.0 (K052061) | Medartis, Inc. | 2005-10-21 |
| MULTIPLE RESIN TOOTH BONDING AGENT (K052501) | Cosmedent, Inc. | 2005-10-21 |
| DEPUY CAS HIP INSTRUMENTATION (K052178) | DePuy Orthopaedics, Inc. | 2005-10-21 |
| ELECTROSURGICAL GENERATOR SYSTEM, MODEL ES 3000 (K052857) | Senorx, Inc. | 2005-10-21 |
| GEM PREMIER 3000 (K052121) | Instrumentation Laboratory CO | 2005-10-21 |
| DIAGNODENT (K051909) | Kavo America | 2005-10-21 |
| MODIFICATION TO CD HORIZON SPINAL SYSTEM (K052609) | Medtronic Sofamor Danek | 2005-10-21 |
| POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A) (K052161) | Cardiac Science, Inc. | 2005-10-21 |
| SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) (K052631) | Depuy Mitek, A Johnson & Johnson Company | 2005-10-21 |
| AVON PATELLO-FEMORAL JOINT PROSTHESIS (K051948) | Howmedica Osteonics Corp. | 2005-10-21 |
| TGO SPRAY (K051812) | Laboratoires Carilene S.A.S. | 2005-10-21 |
| MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM (K052734) | Medtronic Sofamor Danek | 2005-10-21 |
| EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR (K043520) | Emg Technology Co., Ltd. | 2005-10-21 |
| ULTRACLEAN HANDCONTROLLED SUCTION COAGULATOR, MODEL 130182, 130183, 130184, 130185; ULTRACLEAN FOOTCONTROLLED SUCTION (K052104) | Conmed Corporation | 2005-10-21 |
| SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE (K052652) | Smith & Nephew, Inc. | 2005-10-21 |
| CONCORDE VBR SPINAL SYSTEM (K052746) | Depuy Spine, Inc. | 2005-10-21 |
| AVANTE LED CURING UNIT, MODEL N44 (K052349) | Pentron Clinical Technologies | 2005-10-21 |
| DEUTSCH ANTI-BLOCKAGE WOUND DRAIN (K052286) | The Catheter Exchange, Inc. | 2005-10-21 |
| SPIDER CERVICAL PLATING (SCP) SYSTEM (K052292) | X-Spine Systems, Inc. | 2005-10-21 |
| SENTINEL CERULOPLASMIN (K051456) | Sentinel Ch. Srl | 2005-10-21 |
| IN6 SAFETY SYRINGE, MODEL 3ML (K051800) | In6 Incuvestor, Inc. | 2005-10-21 |
| PINNACLE CONSTRAINED ACETABULAR LINERS (K052079) | DePuy Orthopaedics, Inc. | 2005-10-21 |
| POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM (K051992) | Vidacare Corporation | 2005-10-20 |
| BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED (K052155) | C.R. Bard, Inc. | 2005-10-20 |
| M3046B COMPACT PORTABLE PATIENT MONITORS (K052707) | Philips Medical Systems | 2005-10-20 |
| NUZONE SYNGARD POWDER FREE POLYMER COATED POLYISOPRENE STERILE SURGICAL GLOVE - ALOE VERA COATED GREEN COLOUR (K051562) | Terang Nusa Sdn Bhd | 2005-10-20 |
| POWERPICC, POLY PER-Q-CATH, 6 FR TL POLY PER-Q-CATH, POWER HOHN AND POWER LINE (K051991) | C.R. Bard, Inc. | 2005-10-20 |
| AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600 (K052203) | Kirwan Surgical Products, Inc. | 2005-10-20 |
| MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS (K052648) | Implant Innovations, Inc. | 2005-10-20 |
| D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER (K052717) | Dideco S.R.L. | 2005-10-20 |
| ALARIS SYSTEM PC UNIT, MODEL 8001 (K051641) | Cardinal Health, Alaris Products | 2005-10-20 |
| VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR (K051056) | Albert Browne , Ltd. | 2005-10-20 |
| SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL (K052409) | Sultan Chemists, Inc. | 2005-10-20 |
| MEDLINE IODOFORM PACKING STRIPS (K052720) | Medline Industries, Inc. | 2005-10-20 |
| LUNAR IDXA (K052581) | Ge Medical Systems Ultrasound and Primary Care Dia | 2005-10-20 |
| AURA-PSG (K050425) | Astro-Med, Inc. | 2005-10-20 |
| G-COAT (K052462) | GC America, Inc. | 2005-10-20 |
| M-SERIES PRO CPAP SYTEM (K052110) | Respironics, Inc. | 2005-10-20 |
| THERMAGE THERMACOOL SKIN MARKETING (K052778) | Thermage, Inc. | 2005-10-20 |
| BRC SOFTWARE PRODUCT (K050192) | Brc Operations Pty Limited | 2005-10-20 |
| ZIRACE (K051501) | Acucera, Inc. | 2005-10-19 |
| EXEL SECURE TOUCH II SAFETY SYRINGE (K052103) | Exelint Intl. Co. | 2005-10-19 |
| CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002 (K052240) | Cardionet, Inc. | 2005-10-19 |
| CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001 (K052514) | Spectranetics Corp. | 2005-10-19 |
| VITAGEL SURGICAL HEMOSTAT SPRAY SET (K052173) | Orthovita, Inc. | 2005-10-19 |
| BLOOD PRESSURE METER, MODEL CH-432 (K052046) | Citizen Watch Co., Ltd. | 2005-10-19 |
| PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM (K052433) | Bioptics, Inc. | 2005-10-18 |
| QUICKSMILE (K052040) | Cosmetic Dental Materials, Inc. | 2005-10-18 |
| TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013 (K051888) | Scantibodies Laboratory, Inc. | 2005-10-18 |
| LONGFEI LFY-I-5 OXYGEN CONCENTRATOR (K033405) | Zhejiang Longfei Industrial Co., Ltd. | 2005-10-18 |
| MODEL 672-BD, HOME UVB LIGHT SOURCE (JORDAN LIGHT); MODEL 2400, 4 (6 FOOT) HO UV LIGHT SOURCE; MODEL 2600, 6 (6 FOOT) HO (K052660) | The Richmond Light Co. | 2005-10-17 |
| ACTICLOT, MODEL 824 (K052124) | American Diagnostica, Inc. | 2005-10-17 |
| REVENEER CERAMIC REPAIR SYSTEM (K052189) | Schutz-Dental GmbH | 2005-10-17 |
| OLECRANONPLATE WITH ANGULAR STABILITY (K052368) | I.T.S. Implantat-Technologie-Systeme GmbH | 2005-10-17 |
| ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) (K052630) | Depuy Mitek, A Johnson & Johnson Company | 2005-10-17 |
| DAR-8000F (K052500) | Shimadzu Medical Systems | 2005-10-17 |
| NEWGEL AND NEWGEL PLUS E (K041704) | Newmedical Technology, Inc. | 2005-10-17 |
| BURANE (K052806) | Wavelight Laser Technologie AG | 2005-10-17 |
| ARTELON SURGICAL SUTURE (K052482) | Artimplant AB | 2005-10-17 |
| PROVEN REVISION MODULAR TIBIAL TRAY (K051976) | Stelkast Company | 2005-10-17 |
| URGENT PC NEUROMODULATION SYSTEM (K052025) | Uroplasty, Inc. | 2005-10-17 |
| TECTONIC CERVICAL PLATE SYSTEM (K051531) | K2m, LLC | 2005-10-17 |
| ICY CATHETER, MODEL IC-3893A (K052443) | Alsius Corp. | 2005-10-17 |
| MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0 (K052571) | Neurognostics, Inc. | 2005-10-17 |
| BIODERM SCIENCES WOUND CREAM (K042352) | Bioderm Sciences, Inc. | 2005-10-17 |
| FRAGMENT SPECIFIC FIXATOR (K052498) | David J. Slutsky MD | 2005-10-17 |
| HDR IORT SHIELDED APPLICATOR (K052351) | Mick Radio-Nuclear Instruments, Inc. | 2005-10-17 |
| DUAL SHOT - CONTRAST DELIVERY SYSTEM (K052633) | Nemoto Kyorindo Co., Ltd. | 2005-10-17 |
| MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150 (K052805) | Esaote, S.p.A. | 2005-10-17 |
| KING I POWERED SCOOTER, MODEL CTL-11 (K052673) | King I Tech Corporation | 2005-10-17 |
| ELECSYS PRECICONTROL BONE (K051543) | Roche Diagnostics Corp. | 2005-10-17 |
| NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM (K052740) | Conmed Integrated Systems (Cmis) | 2005-10-17 |
| MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM (K051815) | Vertebron, Inc. | 2005-10-17 |
| I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000 (K052175) | Uroplasty, Inc. | 2005-10-17 |
| 3.8MM CS FACET COMPRESSION DEVICE (K052043) | Triage Medical, Inc. | 2005-10-17 |
| CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE (K052365) | Rocket Medical Plc | 2005-10-17 |
| CADMAN INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET, MODELS 80-1163, 80-1189 (K052449) | Codman & Shurtleff, Inc. | 2005-10-17 |
| REFORMAT GATEWAY (K052284) | Infinitt Co., Ltd. | 2005-10-17 |
| PROMETAL HN86 (K052463) | Prometal Technologies | 2005-10-14 |
| DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES (K052582) | GE Healthcare | 2005-10-14 |
| ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT IN ZIRCONIA, ATLANTIS GEMEINI + ABUTMENT IN ZIRCONIA (K052070) | Atlantis Components, Inc. | 2005-10-14 |
| CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 (K050265) | Chrono-Log Corp. | 2005-10-14 |
| MILO DENTAL IMPLANT SYSTEM (K050970) | Intra-Lock International | 2005-10-14 |
| STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES (K052085) | Asia-Med GmbH and CO KG | 2005-10-14 |
| IPS E.MAX CAD/IPS E.MAX ZIRCAD (K051705) | Ivoclar Vivadent, Inc. | 2005-10-14 |
| EVIS EXERA 160A SYSTEM (K051645) | Olympus Medical Systems Corporation | 2005-10-13 |
| KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD LEXPRES SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE (K051805) | Tyco Healthcare/Kendall | 2005-10-13 |
| IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS (K051626) | Immunalysis Corporation | 2005-10-13 |
| BELMONT BUDDY FLUID WARMER (K052547) | Belmont Instrument Corp. | 2005-10-13 |