| MODIFICATION TO CD HORIZON SPINAL SYSTEM (K060203) | Medtronic Sofamor Danek | 2006-02-13 |
| IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT (K060130) | Beckman Coulter, Inc. | 2006-02-13 |
| POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE (K053657) | Pt Mahakarya Inti Buana | 2006-02-13 |
| BASIS SPINAL SYSTEM (K060081) | Medtronic Sofamor Danek | 2006-02-13 |
| EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. (K052965) | Guidant Corporation | 2006-02-13 |
| SYNFIX-LR (K053508) | Synthes Spine Co.Lp | 2006-02-13 |
| CONTOUR II SPINAL SYSTEM (K053070) | Altiva Corp. | 2006-02-13 |
| LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM (K052797) | Medtek Devices, Inc. | 2006-02-13 |
| CI KNEE, CI MI TKR (K052966) | Brainlab AG | 2006-02-13 |
| REPROCESSED COMPRESSION SLEEVES (K053316) | Alliance Medical Corp. | 2006-02-13 |
| MARCH HEALTHCARE HEALTH MONITORING KIT (K060194) | March Healthcare Corporation | 2006-02-13 |
| CYNOSURE PHOTOGENICA V-STAR LASER (K053608) | Cynosure, Inc. | 2006-02-13 |
| SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS (K060144) | Galil Medical , Ltd. | 2006-02-13 |
| WWMED, MODEL 401 (K051961) | Wong Way Corporation | 2006-02-10 |
| MODIFICATION TO: VACLOK SYRINGE (K060095) | Wrightmedicaltechnologyinc | 2006-02-10 |
| FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES (K052983) | Paragon Vision Sciences | 2006-02-10 |
| PROCERA SOFTWARE, MODEL 33145 (K053602) | Nobel Biocare AB | 2006-02-10 |
| WILLCARE, MODEL GW-1020 (K052594) | Icu Medical, Inc. | 2006-02-10 |
| HEARID WIDEBAND MIDDLE EAR POWER ANALYZER (K053216) | Mimosa Acoustics, Inc. | 2006-02-10 |
| MEDIPORT (K060210) | Maxant Technologies, Inc. | 2006-02-10 |
| WUZHOU SYRINGE, WITH/WITHOUT NEEDLE (K060211) | Wenzhou Wuzhou Group Co. , Ltd. | 2006-02-10 |
| IPLAN (K053127) | Brainlab AG | 2006-02-09 |
| SOOTHIES GEL PADS (K052858) | Puronxy, Inc. | 2006-02-09 |
| NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT (K052591) | Clinical Data, Inc. | 2006-02-09 |
| C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS (K053603) | Roche Diagnostics Corp. | 2006-02-09 |
| ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000 (K053032) | Acro Biotech, LLC | 2006-02-09 |
| NRBC-CHEX FOR LH (K060083) | Streck | 2006-02-09 |
| PBS MODEL 701A COMPRESSION THERAPY DEVICE (K060220) | Mego Afek | 2006-02-09 |
| THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT (K053644) | Vascular Solutions, Inc. | 2006-02-09 |
| EMBRACE WETBOND CLEAR SEALANT (K052281) | Pulpdent Corporation | 2006-02-08 |
| CARBONAID GAS DIFFUSER (K052125) | Cardia Innovation AB | 2006-02-08 |
| OPTECURE (K050806) | Exactech, Inc. | 2006-02-08 |
| SIMPLANT DR. JAMES (K053592) | Materialise NV | 2006-02-08 |
| DIAGNODENT 2190 WITH PERIODONTAL PROBE (K060080) | Kavo Dental Corporation | 2006-02-08 |
| INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325 (K053618) | Hutchinson Technology, Inc. | 2006-02-08 |
| KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM (K060079) | Eastman Kodak Company | 2006-02-08 |
| BIO-RAY SDX DIGITAL X-RAY SYSTEM (K060179) | Sigma Biomedics, Inc. | 2006-02-08 |
| DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS (K052499) | Diasorin S.P.A | 2006-02-08 |
| ADVANCED UROLOGICAL CATHETER (K053429) | Entracare, LLC | 2006-02-08 |
| KODAK PACS (K060055) | Eastman Kodak Company | 2006-02-07 |
| IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02 (K052793) | Pharmacia Diagnostics AB | 2006-02-07 |
| XLTEK NEUROPATH, MODEL PK1070 (K053058) | Excel Tech. , Ltd. | 2006-02-07 |
| EL-ACL SCREEN; EL-ACL IGM, IGG, IGA (K060176) | Theratest Laboratories, Inc. | 2006-02-07 |
| ROCHE ELECSYS ANTI-TG (K053426) | Roche Diagnostics Corp. | 2006-02-07 |
| VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS (K060142) | Vascutek, Ltd. | 2006-02-07 |
| TRIMED BONE PLATES (K060041) | TriMed, Inc. | 2006-02-07 |
| DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR (K053576) | Dade Behring, Inc. | 2006-02-07 |
| LYSUS INFUSION SYSTEM (K060084) | Ekos Corp. | 2006-02-07 |
| AESKULISA GLIA A AND AESKULISA GLIA G (K052439) | Aesku Diagnostics | 2006-02-07 |
| MODIFICATION TO: MINIMESH POLYPROPYLENE MESH (K053361) | Mpathy Medical Devices, Ltd. | 2006-02-06 |
| MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS (K060107) | Exactech, Inc. | 2006-02-06 |
| EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (K053061) | Dade Behring, Inc. | 2006-02-06 |
| SHEFFIELD BRAND WARMING LUBRIGEL PERSONAL LUBRICANT (K052162) | Sheffield Laboratories, Div. of Faria Limited, LLC | 2006-02-06 |
| COLUMBUS (CR) TOTAL KNEE SYSTEM (K053390) | Aesculap, Inc. | 2006-02-06 |
| SEJOY, MODEL MT-403 (K051699) | Sejoy Electronics & Instruments Co., Ltd. | 2006-02-06 |
| MODIFICATION TO: V.A.C. GRANUFOAM SILVER PROTECTION DRESSING (K053627) | Kci USA, Inc. | 2006-02-06 |
| ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056 (K053094) | Advanced Bio-Surfaces, Inc. | 2006-02-06 |
| DATEX-OHMEDA PRESTIN MODULE (MODEL FAMILY E-PRESTIN, INCLUDING E-PRESTIN, E-RESTIN, E=PRETIN, E-PP AND E-PT/E-P) (K051217) | GE Healthcare | 2006-02-03 |
| AEGIS ANTERIOR LUMBAR PLATE SYSTEM (K052546) | Depuy Spine, Inc. | 2006-02-03 |
| SUCRALFATE AND CARAFATE PASTE KITS (K043587) | Patrick D. Mcgrath Ph.D | 2006-02-03 |
| VIELLE LUBRICANT (K051288) | Cst Medical Limited | 2006-02-03 |
| HOCA EZ-CARE BP108, TENDER-CARE BP109 (K052671) | Hoca Medical Microsystem, Inc. | 2006-02-03 |
| BIOGRAPH 6 (K060060) | Siemens Medical Solutions USA, Inc. | 2006-02-03 |
| COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES (K052796) | Valleylab | 2006-02-03 |
| EZLOC FEMORAL FIXATION DEVICE (K053461) | Arthrotek, Inc. | 2006-02-03 |
| ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II (K053006) | Rossmax Internationl , Ltd. | 2006-02-03 |
| RES TRAXX DATA CENTER (K053205) | Resmed, Ltd. | 2006-02-03 |
| MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - AMPICILLIN (K060088) | Dade Behring, Inc. | 2006-02-03 |
| INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET (DEN060008) | Centers for Disease Control and Prevention | 2006-02-03 |
| GRT LITE, MODEL 8-A (K050668) | Grt Solutions, Inc. | 2006-02-03 |
| FRAMELESS RADIOSURGERY COMPONENTS (K053500) | Brainlab AG | 2006-02-03 |
| SUNIPAN IMAGING SYSTEM & ACCESSORIES (K060149) | Suni Medical Imaging, Inc. | 2006-02-03 |
| COVACLEARAG COLLAGEN WITH SILVER ANTIMICROBIAL GEL SHEET DRESSING (K052696) | Covalon Technologies, Ltd. | 2006-02-03 |
| INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A (K053204) | Draeger Medical AG & Co. Kgaa | 2006-02-03 |
| DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES (K053240) | Sunrise Medical | 2006-02-03 |
| MODIFICATION TO S4 SPINAL SYSTEM (K060152) | Aesculap, Inc. | 2006-02-03 |
| IMMULITE/IMMULITE 1000 TURBO INTACT PTH (K053533) | Diagnostic Products Corporation | 2006-02-03 |
| DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS (K053411) | Microgenics Corp. | 2006-02-03 |
| CEDARA I-RESPONSE CEDARA PET/CT (K053301) | Cedara Software Corp. | 2006-02-03 |
| TEMPBOND CLEAR WITH TRICLOSAN (K053565) | Sybron Dental Specialties, Inc. | 2006-02-03 |
| MDL SERIES DIODE LASERS, MODEL MDL-10/15 (K042114) | Vision Lasertechnik, GmbH | 2006-02-03 |
| AMS MALE TRANSOBTURATOR SLING SYSTEM (K053371) | American Medical Systems, Inc. | 2006-02-03 |
| MAESTRO MDTL LASER SYSTEM (K053473) | Advanced Medical Technologies, Inc. | 2006-02-03 |
| TENDON WRAP TENDON PROTECTOR (K053655) | Integra LifeSciences Corporation | 2006-02-03 |
| STRAUMANN ORTHOSYSTEM (K060062) | Institut Straumann AG | 2006-02-03 |
| T-SLING (K050516) | Herniamesh S.R.L. | 2006-02-03 |
| GRANTALDER RHAPSODY ACCESS PORT AND CATHETER (K043178) | Grantadler Corportation | 2006-02-02 |
| LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM (K052446) | Hoana Medical, Inc. | 2006-02-02 |
| AQUADEX FLEXFLOW SYSTEM (K060008) | Chf Solutions, Inc. | 2006-02-02 |
| FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I (K052192) | Femspec LLC | 2006-02-02 |
| KANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND ACUPUNCTURE NEEDLES (K052731) | Daxin LI | 2006-02-01 |
| BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE (K053443) | Regent Medical Americas, LLC | 2006-02-01 |
| TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS) (K052608) | Bl Healthcare, Inc. | 2006-02-01 |
| PREFORMANCE POSTS (K053170) | Implant Innovations, Inc. | 2006-02-01 |
| RADIANCY FACIAL SKINCARE DEVICE (K052991) | Radiancy (Israel) , Ltd. | 2006-02-01 |
| YAG MIR FAMILY LASER (K053421) | Cynosure, Inc. | 2006-02-01 |
| SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS (K053178) | Hu-Friedy Mfg. Co., Inc. | 2006-02-01 |
| LUCAS (K053403) | Jolife AB | 2006-02-01 |
| INTERFACE (K053103) | Apex Dental Materials, Inc. | 2006-02-01 |
| MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E (K053177) | Medtronic Minimed | 2006-01-31 |