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

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    TEST PRESSURE GAUGE #6675-32

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

    Medline Quick Switch Valve with ENFit Connector

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

    SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND ST-Y0003-H

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

    COVEREDGE? 32

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·July 16, 2025

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 21, 2014

    EXTERNAL PULSE GENERATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·October 15, 2012

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 22, 2015

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·April 7, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021