| MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT (K052622) | Macan Engineering Co. | 2005-12-09 |
| MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-9900 (K053346) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005-12-09 |
| GLUCOSE PILOT (K052208) | Tianjin New Bay Bioresearch Co., Ltd. | 2005-12-09 |
| I-NEB INSIGHT AAD SYSTEM (K052941) | Profile Therapeutics Plc | 2005-12-09 |
| A & I PEDIATRIC WHEELCHAIRS, MODELS RWAL2006-12, LT3207-12. A & I BARIATRIC WHEELCHAIRS, MODEL NO. WCDE2611P, WCDE2811P (K052586) | Taiwan an I Co., Ltd. | 2005-12-09 |
| CRONUS GUIDEWIRE, MODEL 001-001470-1 (K051373) | Stereotaxis, Inc. | 2005-12-09 |
| MINIMATE COMPRESSOR (K051691) | Precision Medical, Inc. | 2005-12-09 |
| BREFORMANCE (K052781) | Bredent-Products For the Dental Technician Laborat | 2005-12-09 |
| AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A (K053157) | Dade Behring, Inc. | 2005-12-09 |
| OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615 (K052396) | Oxysure Systems, Inc. | 2005-12-09 |
| STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES (K053120) | Excelsior Medical Corp. | 2005-12-09 |
| GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H (K051520) | Gambro Renal Products | 2005-12-09 |
| COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES (K053189) | Zimmer, Inc. | 2005-12-09 |
| CURAE'LASE CL1000 IR LASER SYSTEM (K053201) | Curae'Lase, Inc. | 2005-12-09 |
| POWDER FREE STERILE LATEX SURGICAL GLOVES (K052177) | Hartalega Sdn Bhd | 2005-12-09 |
| COOK FORMULA 418 BILIARY STENT SYSTEM (K052539) | Cook, Inc. | 2005-12-09 |
| LAGUNA MONOAXIAL PEDICLE SCREW SYSTEM (K051275) | Allez Spine, LLC | 2005-12-09 |
| AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP (K052221) | Sorenson Medical, Inc. | 2005-12-08 |
| ENDOSSEOUS DENTAL IMPLANT SYSTEM (K052490) | Northern Implants, LLC | 2005-12-08 |
| SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL SV-S23BL35VS (K052887) | Terumo Europe N.V. | 2005-12-08 |
| ROBIN HOOD VEST (K051300) | Kamber Corporation | 2005-12-08 |
| NEXUSTKO NEEDLELESS ACCESS DEVICE, MODEL NIS-5 (K053129) | Nexus Medical, LLC | 2005-12-08 |
| BIOPURE MTAD ROOT CANAL CLEANSER (K053167) | Dentsply Intl., Inc. | 2005-12-08 |
| MPS ACACIA MEDFLO ELASTOMERIC PUMP (K052451) | Mps Acacia | 2005-12-08 |
| CADIMAS VERSION 1.0 (K052023) | Alan Penn & Associates., Inc. | 2005-12-08 |
| RESOLUTION ENDOVASCULAR SYSTEM (K052428) | Omnisonics Medical Technologies | 2005-12-08 |
| MIRA-FLEX 18 MICROCATHETER (K052841) | Cook, Inc. | 2005-12-08 |
| AMEDITECH DRUGSMARTCUP (K053175) | Ameditech, Inc. | 2005-12-08 |
| MPS ACACIA NERVE BLOCK NEEDLE (K052946) | Mps Acacia | 2005-12-08 |
| MICRUS MODIFIED MICROCOIL 18-SYSTEM, CERECYTE, MODEL CSP & CHE (K053160) | Micrus Endovascular Corporation | 2005-12-07 |
| EXTENDSURE HBFASC CONTROL (K053031) | Cantebury Scientific , Ltd. | 2005-12-07 |
| SYNTHES PANGEA MONOAXIAL SYSTEM (K052151) | Synthes Spine Co.Lp | 2005-12-07 |
| SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100 (K052108) | Sein Electronics Co., Ltd. | 2005-12-07 |
| UTOPIA (K052249) | Respcare, Inc. | 2005-12-07 |
| EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE) (K053281) | Emageon, Inc. | 2005-12-07 |
| SMITH & NEPHEW MODULAR HIP (K052426) | Smith & Nephew, Inc. | 2005-12-07 |
| KALIX II IMPLANT, MODEL 141 0XX WITH XX (K053093) | New Deal, S.A. | 2005-12-07 |
| BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER (K051513) | Bipore, Inc. | 2005-12-07 |
| SMITH & NEPHEW PLATFORM HIP STEM (K052275) | Smith & Nephew, Inc. | 2005-12-07 |
| GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL (K053200) | W. L. Gore & Associates, Inc. | 2005-12-07 |
| TOTAL BILE ACIDS ASSAY, MODEL DZ042A (K051714) | Diazyme Laboratories | 2005-12-07 |
| GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL (K053202) | W.L. Gore & Associates | 2005-12-07 |
| ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL (K051733) | Drg Intl., Inc. | 2005-12-07 |
| DISTAL RADIO-ULNAR JOINT IMPLANT (K053119) | Aptis Medical, LLC | 2005-12-07 |
| MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001 (K053325) | Mediwatch, Ltd. | 2005-12-07 |
| MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM (K051693) | Bayer Healthcare, LLC | 2005-12-07 |
| MESA SPINAL SYSTEM (K052398) | K2m, LLC | 2005-12-07 |
| E-SAN BLUETOOTH CRADLE (K052343) | E-San Limited | 2005-12-07 |
| INFUSIONCATH PERIPHERAL INFUSION CATHETER, MODELS VF0012, VF0016, VF0024, VF0028, VF0032, VF0036, VF0040, VF0044 (K052738) | Veinrx, Inc. | 2005-12-06 |
| POROUS TITANIUM ACETABULAR AUGMENTS (K052888) | Biomet Manufacturing Corp | 2005-12-06 |
| ARTHROCARE 8000S COBLATOR SURGERY SYSTEM (K053297) | Arthrocare Corp. | 2005-12-06 |
| BIOFINITY (COMFILCON A) SOFT CONTACT LENS (K052560) | CooperVision, Inc. | 2005-12-06 |
| XIA SPINAL SYSTEM (K053115) | Stryker Spine | 2005-12-06 |
| VERIFY FLASH INTEGRATOR (K051101) | Albert Browne , Ltd. | 2005-12-06 |
| GELITA-SPON (K051911) | Curamedical, BV | 2005-12-06 |
| INTERBODY INNOVATIONS CEMENT RESTRICTOR (K051371) | Interbody Innovations, Llp | 2005-12-06 |
| INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC (K051638) | Unipath , Ltd. | 2005-12-06 |
| POLYMER COATED ONLINE CHLORINATED POWDER FREE EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR (K050526) | Spi Gloves Sdn. Bhd. | 2005-12-06 |
| OPTIMIZED BARB DESIGN (K052962) | Surgical Specialties Corp | 2005-12-06 |
| POWDER FREE LATEX STERILE PATIENT EXAMINATION GLOVES (K052728) | M/S. Kanam Latex Industries Pvt. , Ltd. | 2005-12-05 |
| SKYLARK URO PROBE (K053007) | Skylark Device & Systems Co., Ltd. | 2005-12-05 |
| MANI NEEDLE & SUTURE PACK (K050150) | Mani, Inc. | 2005-12-05 |
| SYNTHES (USA) STERNAL FIXATION SYSTEM (K052683) | Synthes (Usa) | 2005-12-05 |
| DUOPROSS NEEDLE (K052445) | Duopross Meditech Corporation | 2005-12-05 |
| ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM. (K051484) | Zeus Scientific, Inc. | 2005-12-05 |
| MEDIQ VERSION 1.0 (K052963) | Clario Medical Imaging, Inc. | 2005-12-05 |
| VIAGRAF DBM PASTE (K043209) | Osteotech, Inc. | 2005-12-05 |
| BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 (K052625) | Bionicare Medical Technologies, Inc. | 2005-12-05 |
| ORTHOBLAST II PUTTY AND PASTE (K050642) | Isotis Orthobiologics, Inc. | 2005-12-05 |
| ELECSYS PROBNP IMMUNOASSAY (K051382) | Roche Diagnostics Corp. | 2005-12-05 |
| ANSPACH KNOTLESS ANCHOR (K052572) | The Anspach Effort, Inc. | 2005-12-05 |
| MODEL 418 SERIES WALKERS (K053192) | Mjm International Corporation | 2005-12-05 |
| MEDI BUTLER (K051324) | Medi USA, LP | 2005-12-05 |
| SILVERSEAL SILVERAID WITH X-STATIC (K050726) | Noble Fiber Technologies, Inc. | 2005-12-05 |
| SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER (K052644) | St Jude Medical | 2005-12-05 |
| SYNGO DYNAMICS, VERSION 5.0 (K053133) | Siemens Medical Solutions USA, Inc. | 2005-12-05 |
| LINEAGE A-CLASS POLY LINER (K052026) | Wrightmedicaltechnologyinc | 2005-12-05 |
| BIOHORIZONS SINGLE-STAGE IMPLANT (K053152) | BioHorizons Implant Systems, Inc. | 2005-12-02 |
| FOX PULSE OXIMETER (K051736) | Shunsuke Nakanishi | 2005-12-02 |
| IN VISION GOLD WITH SPIN VISION, MODEL 891 SV (K052348) | Volcano Corporation | 2005-12-02 |
| SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP (K053105) | Synthes (Usa) | 2005-12-02 |
| SYSTEM 12 X3 ACETABULAR INSERTS; SERIES II X3 ACETABULAR INSERTS (K052748) | Howmedica Osteonics Corp. | 2005-12-02 |
| SERIM PERACETIC ACID CHEMICAL INDICATOR (K052388) | Serim Research Corp. | 2005-12-01 |
| GIVEN DIAGNOSTIC SYSTEM (K052184) | Given Imaging , Ltd. | 2005-12-01 |
| ACUMATCH M-SERIES LPB 12/14 FEMORAL STEM (K051858) | Exactech, Inc. | 2005-12-01 |
| STERILE EQUIPMENT COVERS (K052395) | Volcano Corporation | 2005-12-01 |
| SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL (K053248) | Electromed, Inc. | 2005-12-01 |
| VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE (K053186) | bioMerieux, Inc. | 2005-12-01 |
| POWERNEB (K051964) | Comedica , Inc. | 2005-12-01 |
| GRAFTCAGE ACX (K053080) | Osteotech, Inc. | 2005-12-01 |
| ASAHI PTCA GUIDE WIRE (K052339) | Asahi Intecc Co., Ltd. | 2005-11-30 |
| GRAFTON PLUS DBM PASTE (K042707) | Osteotech, Inc. | 2005-11-30 |
| DAMON 3 MODIFIED (K052477) | Ormco Corp. | 2005-11-30 |
| DATRIX CARDIO WIFI ELECTROCARDIOGRAPH (K053083) | Datrix | 2005-11-30 |
| ONE STEP FSH MENOPAUSAL TEST (K052662) | Ind Diagnostic, Inc. | 2005-11-30 |
| IMAGE STAR II (K052610) | Lakeshore Technologies, Inc. | 2005-11-30 |
| SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE (K053128) | Boston Scientific Corp | 2005-11-30 |
| SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOCONUS (K052675) | Synergeyes | 2005-11-30 |
| BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6 (K053082) | Baylis Medical Co., Inc. | 2005-11-30 |
| ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER (K051401) | I-Flow Corp. | 2005-11-30 |