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 ×

    MEDGENERAL SINGLE-USE BULLDOG

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Symmetry Bunnell

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482048528·Symmetry® Stripper, Bunnell Tendon, Round, 6.0 ...

    AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

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

    Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    G7 HI-WALL E1 LINER 32MM F

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code PBI·September 24, 2018

    MINICAP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SWINFORD·Product code KDI·April 30, 2014

    2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 5, 2012

    HARMONIC ACE 36 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code LFL·January 25, 2008

    Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·March 2, 2016

    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