BEUDAMED
    7 results · 34ms · 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.

    COMFORT PERSONAL LUBRICANT

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF

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

    PNEU-WAVE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    LRG TAP PRI MOD NCK 0DEG 38MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code JDI·January 10, 2013

    INJECTION GOLD PROBE?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code KNS·July 7, 2014

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code LFL·February 2, 2008

    Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.

    FDA Enforcement
    Class II ·Ongoing·Genesee BioMedical, Inc.·June 6, 2018