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

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    ENCORE SS-B

    FDA 510(k)
    FDA Class 2 ·Immunology

    Instrument Case

    FDA UDI
    KATENA PRODUCTS, INC.·00841668111086·INSTRUMENT CASE LARGE ALUMINUM

    BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·TRI-TECH FORENSICS, INC.·Product code JKA·July 29, 2025

    BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·TRI-TECH FORENSICS, INC.·Product code JKA·July 29, 2025

    BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·TRI-TECH FORENSICS, INC.·Product code JKA·July 29, 2025

    LARGE AO COUPLING ASNIS III HALL FITTING

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·September 25, 2012

    TRAVELAIR PORTABLE COMPRESSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRODIGY CHOICE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PELVISOFT ACELLULAR COLLAGEN BIOMESH

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORIES·Product code FTM·January 11, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 9, 2014

    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