| ALTRA FX HIP SYSTEM (K063614) | Biomet Manufacturing Corp | 2007-02-20 |
| BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE (K062527) | Multisafe Sdn. Bhd. | 2007-02-20 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVE (K070030) | Super Safe Plastic Products Co., Ltd. | 2007-02-16 |
| RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM (K062567) | Bionime Corporation | 2007-02-16 |
| DOWN PAK (K070246) | Endo Twinn B.V. | 2007-02-16 |
| ZIMMER ONE PIECE IMPLANT, 3.7MM AND 4.7MM, MODELS ZOP37S10, 11, 13, 16; ZOP37A10, 11, 13, 16; ZOP47S10, 11, 13, 16; ZOP4 (K063523) | Zimmer Dental, Inc. | 2007-02-16 |
| MODIFICATION TO AUTOCON II 400 ELECTROSURGICAL GENERATOR (K062464) | KARL STORZ Endoscopy-America, Inc. | 2007-02-16 |
| HEALADEX-P (K063517) | Healagenics, Inc. | 2007-02-16 |
| ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS (K063520) | Roche Diagnostics | 2007-02-16 |
| CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR (K063349) | Cormatrix Cardiovascular, Inc. | 2007-02-16 |
| DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED (K062437) | Technomed Europe | 2007-02-16 |
| SIDESTREAM PLUS (K062689) | Respironics , Ltd. | 2007-02-16 |
| BETA-POWDER (K063236) | Brainbase Corporation | 2007-02-16 |
| MONITORING EAR THERMOMETER, MODEL BTM-D1A (K062445) | Rio Flexon Technology Co., Ltd. | 2007-02-16 |
| INFINITY TELESMART TELEMETRY SYSTEM (K061379) | Draeger Medical Systems, Inc. | 2007-02-16 |
| ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEM (K070088) | Apex BioTechnology Corp. | 2007-02-16 |
| VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840 (K063650) | Puritan Bennett Corp. | 2007-02-15 |
| DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH (K063425) | Dade Behring, Inc. | 2007-02-15 |
| EXSEPT WC WOUND CLEANSER (K061467) | Alcavis International, Inc. | 2007-02-15 |
| CO2 EASY (K070128) | Westmed, Inc. | 2007-02-15 |
| TEMPORARY LIMB SALVAGE SHUNT (K070323) | Vascutek, Ltd. | 2007-02-15 |
| PRISMA M10 PRE SET (K063183) | Gambro Renal Products, Inc. | 2007-02-15 |
| RADIFORCE GX220 AND GS220 MONOCHROME LCD MONITORS (K070131) | Eizo Nanao Corporation | 2007-02-15 |
| TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL (K062946) | Top Corp. | 2007-02-15 |
| QUATTRO CATHETER MODEL IC4593 (K070161) | Alsius Corp. | 2007-02-15 |
| VASCUPUNCTURE PICC GUIDEWIRE (K070150) | Neometrics, Inc. | 2007-02-15 |
| DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH (K063655) | Dade Behring, Inc. | 2007-02-15 |
| SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800 (K063404) | Maquet Critical Care AB | 2007-02-15 |
| BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 230 (K062603) | Biospace Corporation Limited | 2007-02-15 |
| MODIFICATION TO PYRENEES CERVICAL PLATE SYSTEM (K063544) | K2m, Inc. | 2007-02-14 |
| ATLANTIS ABUTMENT FOR 3I MICROMINI IMPLANT (K062069) | Atlantis Components, Inc. | 2007-02-14 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM (GN) 0.5-64UG/ML (K063824) | Becton, Dickinson & CO | 2007-02-14 |
| UNIBLATE ELECTROSURGICAL DEVICE (K070101) | Rita Medical Systems, Inc. | 2007-02-14 |
| EXCEL CONTRA ANGLE HANDPIECE (K061897) | Orthosource, Inc. | 2007-02-14 |
| SPECIAL SPROTTE, CHIBA, DR STEINHOFF KIT (K063697) | PAJUNK GmbH Medizintechnologie | 2007-02-14 |
| IMMUNOCARD STAT! EHEC, MODEL 751630 (K062546) | Meridian Bioscience, Inc. | 2007-02-14 |
| SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING (K062569) | Datascope Corp. | 2007-02-14 |
| COLLAGEN MATRIX ANORGANIC BONE MINERAL BONE GRAFT MATERIALS (K062200) | Collagen Matrix, Inc. | 2007-02-13 |
| CINCH BONE ANCHOR SYSTEM (K062739) | Sapphire Medical, Inc. | 2007-02-13 |
| THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT (K063860) | Vascular Solutions, Inc. | 2007-02-13 |
| ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4) (K063203) | Imc-Heart Way LLC | 2007-02-13 |
| BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE (K063118) | C.R. Bard, Inc. | 2007-02-13 |
| BODIHEALTH SYSTEM (K052836) | Usa Laser Therapeutics, Inc. | 2007-02-13 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVE (K070187) | Hong DI Plastic Products Co., Ltd. | 2007-02-13 |
| PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM (K061252) | Primus Consulting | 2007-02-12 |
| PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 (K070287) | Photonic Optische Gerate GmbH & Cokg | 2007-02-12 |
| 15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55 (K063441) | Spire Biomedical, Inc. | 2007-02-12 |
| MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE (K062953) | Medisystems Corp. | 2007-02-12 |
| NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT (K063549) | Novabone Products, LLC | 2007-02-12 |
| FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE (K063778) | Teleflex Medical | 2007-02-09 |
| INTRALASE FUSION LASER (K063682) | Intra Lase Corp. | 2007-02-09 |
| AEGIS (K070244) | Sentinelle Medical, Inc. | 2007-02-09 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K070075) | Jiangsu Cureguard Glove Co., Ltd. | 2007-02-09 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GN) 0.5-32UG/ML (K063811) | Becton, Dickinson & CO | 2007-02-09 |
| OK METER BLOOD GLUCOSE MONITORING SYSTEM (K063026) | Ok Biotech Co., Ltd. | 2007-02-09 |
| TRILOGY RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYSTEM (K070094) | Varian Medical Systems, Inc. | 2007-02-09 |
| ELECTROPULSE - LOW BACK PAIN (K062532) | Pain Relief Technologies | 2007-02-09 |
| S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM (K062012) | Aesculap, Inc. | 2007-02-09 |
| CLEARFIL MAJESTY POSTERIOR (K063595) | Kuraray America, Inc. | 2007-02-09 |
| DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES (K063114) | Coeur, Inc. | 2007-02-09 |
| NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET (K063477) | Novamed, LLC | 2007-02-09 |
| PALOMAR LUX2940 HANDPIECE (K063571) | Palomar Medical Technologies, Inc. | 2007-02-09 |
| LORENZ ORTHODONTIC ANCHORAGE SYSTEM (K063386) | Walter Lorenz Surgical, Inc. | 2007-02-09 |
| OLYMPUS XEU-M60A ENDOSCOPIC ULTRASOUND CENTER; XGF-UM180 ULTRASONIC GASTROVIDEOSCOPE (K063683) | Olympus Medical Systems Corporation | 2007-02-08 |
| LISFRANC PLATE (K063820) | New Deal, S.A. | 2007-02-08 |
| EUSOL-C (K063617) | Al.Chi.Mi.A | 2007-02-08 |
| MODIFICATION TO TTC PLATES (K070160) | New Deal, S.A. | 2007-02-08 |
| MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CHLORAMPHENICOL (4-16 UG/ML) (K063564) | Dade Behring, Inc. | 2007-02-08 |
| FINECUBE DENTAL CT (K063622) | The Yoshida Dental Mfg. Co., Ltd. | 2007-02-08 |
| CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL, LIGHTWEIGHT-PROBE DIGITAL CLINICAL THERMOMETER (K070028) | Actherm, Inc. | 2007-02-08 |
| SPYGLASS IRRIGATION SYSTEM (K063700) | Medical Scientific, Inc. | 2007-02-08 |
| MICROLUX TRANSILLUMINATOR (K062961) | Addent, Inc. | 2007-02-08 |
| INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0 (K062894) | Dailycare Biomedical, Inc. | 2007-02-08 |
| MP5 INTELLIVUE PATIENT MONITOR (K063725) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007-02-08 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES (K070008) | Zibo Hengde Plastic & Rubber Products Co., Ltd. | 2007-02-08 |
| POSITIONER (K063839) | C-Rad Positioning AB | 2007-02-08 |
| CLAVIS (K062478) | Medtronic A/S | 2007-02-08 |
| DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY (K061131) | Orthocon, Inc. | 2007-02-08 |
| FORSURE DISPOSABLE SYRINGE WITH NEEDLE, MODEL 1CC, 3C, 5CC, 10CC, 20CC, 50CC (K062753) | Surgimed, Inc. | 2007-02-08 |
| EMBRYOASSIST (K061309) | Medicult A/S | 2007-02-08 |
| MODIFICATION TO LAPIDUS PLATE (K070241) | New Deal, S.A. | 2007-02-08 |
| MONOCHROME LCD MONITOR, MODEL RADIFORCE GX320 (K070122) | Eizo Nanao Corporation | 2007-02-08 |
| DURAFLEX (K063626) | Cosmetic Dental Materials, Inc. | 2007-02-08 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (K070043) | Super Safe Plastic Products Co., Ltd. | 2007-02-08 |
| KAVO EVEREST C-TEMP (K063624) | Kavo America | 2007-02-08 |
| TEPHAFLEX ABSORBABLE SUTURE (DEN060003) | Tepha, Inc. | 2007-02-08 |
| POWDER NITRILE EXAMINATION GLOVE (WHITE AND BLUE COLOR) (K063522) | Hl Rubber Industries Sdn Bhd | 2007-02-08 |
| HEMOCATH II (K062901) | Med-Conduit, Inc. | 2007-02-08 |
| BASAL DORSAL PLATES (K063831) | Newdeal Sas | 2007-02-07 |
| SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17 (K063603) | Suturtek Incorporated | 2007-02-07 |
| SUNIRAY II DIGITAL RADIOGRAPHY SYSTEM (K070219) | Suni Medical Imaging, Inc. | 2007-02-07 |
| PLEXUR P (K061982) | Osteotech, Inc. | 2007-02-07 |
| INFINITI SYSTEM (K060564) | AutoGenomics, Inc. | 2007-02-07 |
| OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407 (K063660) | Well-Life Healthcare Limited | 2007-02-07 |
| SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION (K062793) | Maquet Critical Care AB | 2007-02-07 |
| POWDERED VINYL PATIENT GLOVE (K070046) | Shijiazhuang Lianhe Shunda Plastic Products Co., L | 2007-02-07 |
| STARCLOSE HEX-HUB DILATOR (K062554) | Abbott Vascular, Inc. | 2007-02-06 |
| EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG) (K063167) | Phasein AB | 2007-02-06 |
| MAMMAPRINT (DEN070009) | Agendia BV | 2007-02-06 |
| STAODYN MAX PRESET, MODEL 4470 (K061516) | Compex Technologies, Inc. | 2007-02-06 |