BEUDAMED
    8 results · 19ms · 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.

    NO-SCALPEL VASCETOMY INSTRUMENTS

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    MICROHYBRID 11

    FDA 510(k)
    FDA Class 2 ·Dental

    CLICKFINE PEN NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SIGMA 300 DR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code DXY·December 13, 2010

    PRECISION SPECTRA®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 9, 2014

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·December 27, 2012

    Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part number 03.010.052). The Recon Locking Aiming Arm for Lateral Entry Femoral Recon Nails- EX is used when locking the Femoral Nail-EX. The Aiming Arm for Titanium (TI) Cannulated Tibial Nails-EX is used when locking the Tibial Nail-EX.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·March 25, 2015

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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