BEUDAMED
    9 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.

    MANUAL OPHTHALMIC SURGICAL INSTRUMENTS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    ARTERIAL GRAFT SIZERS

    FDA 510(k)

    ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT

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

    MALLORY/HEAD - PF ACETABULAR COMPONENT

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDI·March 8, 2017

    SECURA DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 10, 2014

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·November 2, 2012

    DISCOVERY II

    FDA Adverse Event
    Malfunction ·GUIDANT CLONMEL IRELAND·Product code NVZ·October 8, 2010

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012