Atlas FDA

2006

3,217 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SUNSPOTS PRE-GELLED SURFACE ELECTRODES (K062198)Axon Systems, Inc.2006-12-19
VISTA AVS (K063600)Summit Doppler Systems, Inc.2006-12-19
MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM (K063499)Scandius Biomedical, Inc.2006-12-19
U-CLIP DEVICE (K062821)Medtronic Neurosurgery2006-12-19
SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM (K063049)Synthes (Usa)2006-12-18
QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA (K062929)Quest Diagnostics, Inc.2006-12-18
KOWA SL-15 (K063640)Kowa Co. , Ltd.2006-12-18
LOSS OF RESISTANCE SYRINGE (K061737)Robert Busse & Co., Inc.2006-12-18
LORENZ STERNAL CLOSURE SYSTEM (K063506)Walter Lorenz Surgical, Inc.2006-12-18
PROGENIX DBM PUTTY AND PASTE (K060794)Medtronic Sofamor Danek2006-12-18
MOBIS SPINAL IMPLANT (K061082)Signus Medizintechnik GmbH2006-12-18
BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS (K062971)Akers Biosciences, Inc.2006-12-18
SOMNOFIT (K060795)Strategic Counsel Sarl2006-12-18
V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC (K062577)Tz Medical, Inc.2006-12-15
PIPELINE II ACCESS SYSTEM (K062814)Depuy Spine, Inc.2006-12-15
CERAMIC BOND (K062345)Voco GmbH2006-12-15
ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER (K061680)Atrium Medical Corp.2006-12-15
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (K063446)C.R. Bard, Inc.2006-12-15
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS (K062426)DePuy Orthopaedics, Inc.2006-12-15
VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE VERIFIERS I, II AND III (K062460)Ortho-Clinical Diagnostics, Inc.2006-12-15
NEXUS IRRIGATION TUBING SET (K062551)Nexus Medical, LLC2006-12-15
OSSPRAY CLEANING COMPOUND (K062502)Ospray, Ltd.2006-12-15
BF+ (PH) (K061462)Ldr Spine USA2006-12-15
LASER-D68 (K061656)Laser Pain Clinics LP2006-12-15
OCTAX LASER SHOT SYSTEM (K062524)Minitube of America, Inc.2006-12-15
SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM (K061879)Hemodiagnostica, LLC2006-12-15
VERSALOK ANCHOR WITH FREE STRANDS OF ORTHOCORD SUTURE (210808), ETHIBOND SUTURE (210809), AND PANACRYL SUTURE (210810) (K063478)Depuy Mitek, A Johnson & Johnson Company2006-12-15
SYNTHETIC VINYL PATIENT EXAM GLOVES, PRE-POWDERED, YELLOW (K062714)Baoding Guanzhong Glove Co., Ltd.2006-12-15
VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208 (K063591)Ortho-Clinical Diagnostics, Inc.2006-12-15
PRONTO V3 EXTRACTION CATHETER, MODEL 5003 (K063371)Vascular Solutions, Inc.2006-12-14
HIGH SPEED AIR TURBINE HANDPIECE, MODELS SUPER-AIR AND SUPER-QD SERIES (K062947)Peng Lim Enterprise Co., Ltd.2006-12-14
RPM RESPIRATORY GATING SYSTEM (K063270)Varian Medical Systems, Inc.2006-12-14
APERFIX TIBIAL IMPLANT WITH INSERTER (K063070)Cayenne Medical, Inc.2006-12-14
SUPRACOR BALLOON CATHETER (K062582)Abiomed, Inc.2006-12-14
COPILOT HEALTH MANAGEMENT SYSTEM (K062770)Abbott Diabetes Care, Inc.2006-12-14
FLOSIMPLE ARTHROSCOPY PUMP A120 (K062380)W.O.M. World of Medicine AG2006-12-14
INTAI BONE PLATE AND BONE SCREW SYSTEM; INTAI DHS/DCS PLATE SYSTEM (K063020)Intai Technology, Inc.2006-12-14
STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000 (K062640)Stryker Instruments2006-12-14
PULMOLIFE (K061283)Micro Medical, Ltd.2006-12-14
E-CHECK (XE) (K063218)Streck2006-12-14
2MP MEDICAL COLOR REFERENCE DISPLAY, MODEL MDC2130-2HC (K063579)Chi Lin Technology Co., Ltd.2006-12-14
LAIMAD (K062333)Steven Lamberg, D.D.S2006-12-14
CELLSEARCH CIRCULATING TUMOR CELL KIT (K062013)Veridex, LLC2006-12-14
C-U2 (K062897)Cefla S.C.R.L.2006-12-14
RUIKE, MODEL 3331 (K062676)Shanghai Ruike Sports Goods Co., Ltd.2006-12-14
PEAK SE, MODEL 5135 (K063558)Ultradent Products, Inc.2006-12-14
SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM (K063580)Medison Co., Ltd.2006-12-14
INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003 (K061901)Ino Therapeutics2006-12-14
PROTON THERAPY SYSTEM (K062891)Indiana University Cyclotron Facility2006-12-14
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS (K062969)Medline Industries, Inc.2006-12-14
AIR-FLEX WITH AUTO-DISTRACTION (K063034)Hill Laboratories Co.2006-12-14
CROSSPLAN / ACCUSOFT-XL V.4.04 (K063482)Direx Systems Corp.2006-12-14
AESKULSKA BETA2-GLYCO-A (K062217)Aesku, Inc.2006-12-13
BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (K063343)Bioptigen, Inc.2006-12-13
MODULAR REPLACEMENT ELBOW SYSTEM (K062845)Howmedica Osteonics Corp.2006-12-13
RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04 (K062612)Rayner Surgical, Inc.2006-12-13
V.A.C. ATS LARGE (1000 ML) CANISTER WITH GEL, MODELS M6275093/5, M6275093/10 (K063426)Kci USA, Inc.2006-12-13
ZOLL E SERIES WITH REAL CPR HELP (K062177)ZOLL Medical Corporation2006-12-13
BIS BILATERAL SENSOR (K062692)Aspect Medical Systems, Inc.2006-12-13
TF ROTARY NICKEL TITANIUM FILE (K062856)Ormco Corp.2006-12-13
MODIFICATION TO AQUADEX FLEXFLOW SYSTEM (K062922)Chf Solutions, Inc.2006-12-13
QUANTA LITE CELIAC DGP SCREEN (K062708)Inova Diagnostics, Inc.2006-12-13
ARTHREX PUSHLOCK (K063479)Arthrex, Inc.2006-12-13
NFIX II PEDICLE SCREW SYSTEM (K061774)N Spine, Inc.2006-12-13
REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351 (K052465)Heartsine Technologies, Inc.2006-12-12
MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 499-38 (K063414)Encore Medical L.P.2006-12-12
ACCULOC BREAST LOCALIZATION SYSTEM (K063274)Northwest Medical Physics Equipment, Inc.2006-12-12
VASCUTRAK PTA DILATION CATHETER (K063657)Ymed, Inc.2006-12-12
CYSTOGLIDE INTRODUCER SHEATH (K052298)Percutaneous Systems, Incorporated2006-12-12
IMCO-STAT (K063392)Imco Technologies2006-12-12
PEAK BOND, MODEL 5133 (K063557)Ultradent Products, Inc.2006-12-12
TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS (K063080)Advanced Neuromodulation Systems2006-12-12
ECHELON MR-RCC-150 CARDIAC COIL (K063513)Hitachi Medical Systems America, Inc.2006-12-12
MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS) (K061033)Miltex, Inc.2006-12-12
VISUALASE ENVISION SOFTWARE SYSTEM (K063505)Biotex, Inc.2006-12-12
BIOSTAR OIA SHIGATOX (K061889)Inverness Medical-Biostar, Inc.2006-12-12
TAP III ANTI-SNORING DEVICE (K062951)Airway Management, Inc.2006-12-12
VECTORVISION HIP SR (K063028)Brainlab AG2006-12-12
RCHIVE PACS (K063253)Sobha Renaissance Information Technology Pvt, Ltd.2006-12-12
OPAL-RAD (K063337)Viztek, Inc.2006-12-12
MEDWEB ADVANCED 3D WEB PACS (K063221)Nexsys Electronics, Inc.2006-12-12
ORI F6T DRY ECG MONITORING ELECTRODE (K062760)Orbital Research, Inc.2006-12-11
BAND-AID(R) BRAND LIQUID BANDAGE (K062602)Johnson & Johnson Consumer Companies, Inc.2006-12-11
MINISPIR; SPIROLAB III (K061875)Mir Medical Intl. Research Srl2006-12-11
XIA STAINLESS STEEL SPINAL SYSTEM (K063428)Stryker Spine2006-12-11
USI DENTAL SCALER, 25XXX SERIES (K062791)Ultrasonic Services, Inc.2006-12-11
ISECURE SYRINGE CARTRIDGE HOLDER (K063180)Hospira, Inc.2006-12-11
OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE (K062280)Ceremed , Inc.2006-12-11
PROCEED VENTRAL PATCH (K061533)ETHICON, Inc.2006-12-11
M-BOLUS EMBOLIC MICROSPHERES (K052509)Scion Cardio-Vascular, Inc.2006-12-11
MODIFICATION TO MODEL 750 SERIES MONITOR (K063087)Cas Medical Systems, Inc.2006-12-11
AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220 (K063379)Amedica Biotech, Inc.2006-12-11
LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526 (K063239)Hospira, Inc.2006-12-11
MODULAR HYBRID GLENOID (K060694)Biomet Manufacturing Corp2006-12-11
MUGARD MUCOADHESIVE ORAL WOUND RINSE (K062795)Access Pharmaceuticals, Inc.2006-12-11
WICK ELECTRODE, MODEL M019260 (K063402)Intelligent Hearing Systems2006-12-11
BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K062211)Bio-Rad Laboratories, Inc.2006-12-08
SURFACE COAT (K063228)Kuraray America, Inc.2006-12-08
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0.06-32MG/ML LONG DILUTION SEQUENCE (K063365)Dade Behring, Inc.2006-12-08
COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1 (K061902)Inditherm Medical2006-12-08
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