BEUDAMED
    8 results · 33ms · 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.

    ELLIK EVACUATOR

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

    ICONACY(TM) I-Hip(TM)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DIMENSION IRON CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FUTURO BRAND SPORT HINGED KNEE BRACE

    FDA Adverse Event
    Other ·3M CONSUMER HEALTH CARE·Product code ITQ·November 9, 2012

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·June 10, 2014

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·September 22, 2010

    CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·April 17, 2019

    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