BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Steribite

    FDA 510(k)
    FDA Class 2 ·Neurology

    KERATEC WOUND DRESSINGS

    FDA 510(k)
    FDA Unclassified ·Unknown

    ACCURUS 800CS

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·April 7, 2014

    WECK HEM-O-LOK ENDO REMOVER 5MM

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code FZP·October 5, 2010

    ELEVATE PROLAPSE REPAIR SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·December 13, 2012

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·April 20, 2016

    Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025