| CR-PRO (K052938) | Eradlink, Inc. | 2005-11-17 |
| GLAID OCULAR ELECTROPHYSIOLOGY DEVICE (K043367) | Lace Electronica S.R.L. | 2005-11-17 |
| ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS (K050024) | Guangzhou Wondfo Biotech Co., Ltd. | 2005-11-17 |
| IMC SURGICAL GOWNS (K052550) | Intl. Medsurg Connection, Inc. | 2005-11-17 |
| STIMUPLEX HNS-12, MODEL 4892098 (K052313) | Stockert GmbH | 2005-11-17 |
| IMC SURGICAL DRAPES (K052169) | International Medsurg Connection, Inc. | 2005-11-17 |
| EZ-IO (K052408) | Vidacare Corporation | 2005-11-17 |
| CADD-MS 3 AMBULATORY INFUSION PUMP (K051568) | Smiths Medical MD, Inc. | 2005-11-17 |
| SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM (K053084) | Kontron Medical Systems Sas | 2005-11-16 |
| INFINITY ALPHA (K051658) | Draeger Medical Systems, Inc. | 2005-11-16 |
| SLENDERTONE GYMBODY, MODEL 512-01 (K052969) | Bio-Medical Research, Ltd. | 2005-11-16 |
| VERSA-LINK PORCELAIN BONDING SYSTEM (K052699) | Sultan Chemists, Inc. | 2005-11-16 |
| STRYKER SPINE TRIO SPINAL FIXATION SYSTEM (K052971) | Stryker Spine | 2005-11-16 |
| PIEZOSURGERY (K052518) | Piezosurgery S.R.L. | 2005-11-16 |
| INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE (K052624) | Inion , Ltd. | 2005-11-16 |
| CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0 (K052537) | American Medical Sales, Inc. | 2005-11-16 |
| STERLING INTERFERENC SCREW HT (K052405) | Regeneration Technologies, Inc. | 2005-11-16 |
| THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEM (K052950) | Zimmer Trabecular | 2005-11-16 |
| MODIFICATION TO VERTE-STACK SPINAL SYSTEM (K052931) | Medtronic Sofamor Danek | 2005-11-16 |
| REPROCESSED ELECTROPHYSIOLOGY CATHETER (K052414) | Alliance Medical Corp. | 2005-11-16 |
| CONTRAST MEDIA TRANSFER SETS (K052252) | B.Braun Medical, Inc. | 2005-11-16 |
| REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS (K052603) | Alliance Medical Corp. | 2005-11-16 |
| SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) (K053069) | Sonosite,Inc. | 2005-11-16 |
| MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS (K053017) | Invivo Corporation | 2005-11-16 |
| PACP SYSTEM (K053053) | Pioneer Surgical Technology | 2005-11-16 |
| COLOR NIO 2MP, E-2320 C (K052958) | Barcoview | 2005-11-16 |
| TOPEZ TOTAL ANKLE REPLACEMENT (K051023) | Topez Orthopedics, Inc. | 2005-11-15 |
| MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507 (K052596) | Biopro, Inc. | 2005-11-15 |
| NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES (K052526) | Lumenis, Inc. | 2005-11-15 |
| MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000 (K052861) | Sanarus Medical, Inc. | 2005-11-15 |
| SILVERFIL (K053114) | Dunia Perwira Manufacturing Sdn. Bhd. | 2005-11-15 |
| POLY SILOXANE IMPRESSION MATERIAL (K053014) | Clinician'S Choice Dental Products, Inc. | 2005-11-15 |
| PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS (K051711) | Denver Biomedical, Inc. | 2005-11-15 |
| SUPERDIMENSION/BRONCHUS PREMIUM (K052852) | Superdimension, Ltd. | 2005-11-14 |
| AESKULISA ASCA A (K051492) | Aesku, Inc. | 2005-11-14 |
| TELITHROMYCIN 15UG BBL SENSI-DISC (K052876) | Becton, Dickinson & CO | 2005-11-14 |
| RBK PATELLA FEMORAL KNEE (K050473) | Global Orthopaedic Technology, USA, Inc. | 2005-11-14 |
| OLYMPUS CHOLEDOCHOSCOPE, MODEL XCHF-BP160F (K051886) | Olympus Medical Systems Corporation | 2005-11-14 |
| TEH LOONG POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW (K052636) | Teh Loong Corp. | 2005-11-10 |
| ACUSON CYPRESS ULTRASOUND SYSTEM (K052331) | Siemens Medical Solutions USA, Inc. | 2005-11-10 |
| EXTENDED MEASUREMENTS SYSTEM (K051450) | Inovise Medical, Inc. | 2005-11-10 |
| EXTERNAL FIXATION (K052605) | Gexfix USA, Inc. | 2005-11-10 |
| NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P (K052186) | Nellcor Puritan Bennett, Inc. | 2005-11-10 |
| ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL (K052703) | Alden Optical Labs., Inc. | 2005-11-10 |
| JOSTRA HLM TUBING SET (K053025) | Maquet Cardiopulmonary, AG | 2005-11-10 |
| NIPRO HYPODERMIC NEEDLE (K052474) | Nipro Medical Corp. | 2005-11-10 |
| STELLA CERVICAL PLATE (K052763) | Scient'X | 2005-11-10 |
| ANGIOJET XPEEDIOR 120 CATHETER (K052256) | Possis Medical, Inc. | 2005-11-10 |
| SOLANAS POSTERIOR STABILIZATION SYSTEM (K052201) | Alphatec Spine, Inc. | 2005-11-10 |
| KOWA NONMYD 7, KOWA NONMYD A-D (K053026) | Kowa Co. , Ltd. | 2005-11-10 |
| C-PORT ANASTOMOSIS SYSTEM (DEPLOYMENT SYSTEM, CLIP, ACCESSORIES), MODEL FG-000050 (K040832) | Cardica, Inc. | 2005-11-10 |
| WRISTOX MODEL 3100 PULSE OXIMETER (K052829) | Nonin Medical, Inc. | 2005-11-10 |
| CG FUTURE ANNULOPLASTY BAND (K052860) | Medtronic Heart Valves | 2005-11-10 |
| CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 (K051757) | Diagnostic Chemicals , Ltd. | 2005-11-10 |
| GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR (K050550) | Gyrus Medical, Inc. | 2005-11-09 |
| B. BRAUN MODIFIED BICARBONATE DIALYSATE (K052393) | B.Braun Medical, Inc. | 2005-11-09 |
| SMIT SLEEVE (K052228) | Nucletron Corporation | 2005-11-09 |
| TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET (K052148) | Reference Diagnostics, Inc. | 2005-11-09 |
| LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 (K052838) | Bio-Rad | 2005-11-09 |
| DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE (K052314) | Dynarex Corp. | 2005-11-09 |
| PEDIATRIC FEEDING TUBE (K052903) | Promedic, Inc. | 2005-11-09 |
| GE 1.5T SIGNA HDE MR SYSTEM (K052978) | Ge Medical Systems, LLC | 2005-11-09 |
| CLINI-LASE SYSTEM, MODELS CL-BASE, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155, CL-55, CLP-BASE, CLP-275, CLP-55. (K052647) | American Spine Center, Ltd. | 2005-11-09 |
| USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY (K052916) | Usa Instruments, Inc. | 2005-11-09 |
| PARACEM UNIVERSAL DC (K053040) | Coltene/Whaledent AG | 2005-11-09 |
| PROCEDUR-10 (K052075) | Avanca Medical Devices, Inc. | 2005-11-09 |
| AQUADEX SYSTEM (K050609) | Chf Solutions, Inc. | 2005-11-09 |
| ILUMA ORTHOCAT/DENTALCAT (K053046) | Imtec Corp. | 2005-11-08 |
| POLY SILOXANE IMPRESSION MATERIAL (K053018) | Millennium Dental International, Inc. | 2005-11-08 |
| ADVANTAGE WORKSTATION 4.3. (K052995) | GE Healthcare | 2005-11-08 |
| GE DEFINIUM AMX 700, MODEL AMX 700 (K052897) | General Electric Medical Systems | 2005-11-08 |
| MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED) (K051082) | Medtrade Products , Ltd. | 2005-11-08 |
| CRC 15ULTRA (K052595) | Capintec, Inc. | 2005-11-08 |
| MODIFICATION TO: AURORA (K052698) | Aurora Imaging Technology, Inc. | 2005-11-08 |
| POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE (K052877) | Syntex Healthcare Products Co., Ltd. | 2005-11-08 |
| INFINITT G3 PACS (K052545) | Infinitt Co., Ltd. | 2005-11-08 |
| FORTADERM ANTIMICROBIAL WOUND DRESSING (K051647) | Organogenesis, Inc. | 2005-11-08 |
| VERTEFIX VERTEBROPLASTY PROCEDURE SET (K042691) | Cook, Inc. | 2005-11-08 |
| POWDER FREE LATEX EXAMINATION GLOVES, SIZES SMALL, MEDIUM, LARGE, X-LARGE (K052709) | Pt.Shamrock Manufacturing Corp. | 2005-11-08 |
| BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC (K052987) | Noras Rontgen-Und Medizintechnik GmbH | 2005-11-08 |
| POWER RIGHT ANGLE LINEAR CUTTER DIGITAL LOADING UNIT WITH RELOADS (K052910) | Power Medical Interventions, Inc. | 2005-11-07 |
| J. MORITA AZ ULTRASONIC SYSTEM (K053030) | J. Morita USA, Inc. | 2005-11-07 |
| UNI-THREAD SPINAL SYSTEM (K052406) | Spine Vision, Inc. | 2005-11-07 |
| BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 (K043007) | Hyphen Biomed | 2005-11-07 |
| VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN (K052656) | bioMerieux, Inc. | 2005-11-07 |
| MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE (K052437) | Surgical Specialties Corp | 2005-11-07 |
| ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS (K052607) | Arthrex, Inc. | 2005-11-07 |
| IGNITE BONE VOID FILLER KIT (K052913) | Wrightmedicaltechnologyinc | 2005-11-07 |
| SBI AUTOFIX (K052576) | Small Bone Innovations, LLC | 2005-11-07 |
| FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (K052280) | Boston Scientific Corp | 2005-11-07 |
| ABBOTT SPINE, INC. SPINNAKER SYSTEM (K052638) | Abbott Spine, Inc. | 2005-11-07 |
| CALF IMPLANT, MODEL EC17-X (K052505) | Implantech Associates, Inc. | 2005-11-04 |
| SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS (K051312) | Veryan Medical Limited | 2005-11-04 |
| NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE (K052019) | North Coast Medical, Inc. | 2005-11-04 |
| STRYKER SPINE AVS ASL PEEK SPACER (K051205) | Stryker Spine | 2005-11-04 |
| INVOS SYSTEM (K051274) | Somanetics Corp. | 2005-11-04 |
| INO THERAPEUTICS INOBLENDER, MODEL 10004 (K052663) | Ino Therapeutics | 2005-11-04 |
| SAFERSLEEP SYSTEM (K050883) | Safer Sleep, LLC | 2005-11-04 |
| TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050 (K051583) | Tiara Medical Systems, Inc. | 2005-11-04 |
| GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X (K052504) | Implantech Associates, Inc. | 2005-11-04 |