BEUDAMED
    7 results · 23ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    ABUSCREEN(R) ONTRAK(TM) FOR COCAINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DynaBridge

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VOCALIS GEL

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    PRECISION SPECTRA®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 18, 2014

    INOMAX DS (DELIVERY SYSTEM)

    FDA Adverse Event
    Malfunction ·INO THERAPEUTICS, LLC/IKARIA·Product code MRN·October 8, 2010

    STRATUS® CS STAT FLUOROMETRIC ANALYZER

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD·Product code JHX·December 20, 2012

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024