BEUDAMED
    13 results · 26ms · Sources: EU EUDAMED, US FDA

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    HANSON SCAR ADE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Leksell Stereotactic System

    FDA UDI
    Elekta Solutions AB·07340201502372·TABLE FIX X-RAY, FLAT 210 MM

    Myo/Wire II

    FDA UDI
    A & E MEDICAL CORPORATION·10841291101154·SS Suture, 6 per sleeve

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024021·Paddle Shaver, 7mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0103070·Shaver, Closed, 7mm

    LAP DISC 120 X 120MM X 2CM #LD111; LAP DISC 120 X 120MM X 7CM #LD112

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DAVOL ARTHROVENT OUTFLOW TUBING

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NEXGEN OFFSET STEM EXTENSION

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code NJL·April 3, 2013

    4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC KIT

    FDA Adverse Event
    Malfunction ·C. R. BARD INC. (BASD)·Product code LJS·February 15, 2011

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·April 30, 2008

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013