BEUDAMED
    10 results · 20ms · 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.
    Filters Regulation: Us FDA ×

    POCKET NEB

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CYNOSURE CELLULAZE LASER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·July 17, 2015

    BAKRI TAMPONADE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code OQY·May 2, 2018

    AKREOS MICRO INCISION LENS

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code HQL·October 1, 2014

    PELVICOL ACELLULAR COLLAGEN MATRIX

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORIES·Product code FTL·April 18, 2013

    RIVAL PTA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·June 20, 2011

    BD INTIMA-II 24GAX0.75IN PRN SLM NPVC

    FDA Adverse Event
    Injury ·BD SUZHOU (MDS)·Product code FOZ·February 9, 2024

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015