BEUDAMED
    7 results · 17ms · 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 THC

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    REPROCESSED ENT SHAVERS

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

    AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water

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

    PRECISION®

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

    EON MINI 16-CHANNEL IPG

    FDA Adverse Event
    Malfunction ·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·October 8, 2010

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code HET·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