BEUDAMED
    12 results · 18ms · 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.

    BEHRING RAPIGNOST TOTAL SCREEN L URINE TEST STRIPS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PREMIER® Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074229164·PLATE 6861255 55MM FSP ANTERIOR CRV

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517157959·CoRoent® XLF, 12x18x55mm

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776201098·MCINTYRE ANTERIOR CHAMBER CANNULA GA ANGL

    meso-relle (AAL34, AAL36, AM30G)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACCUTRAK DELIVERY CATHETER SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·November 28, 2017

    CONCERTO II CRT-D

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

    CYLOS DR

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVZ·October 1, 2010

    GOBED II MED/SURG BED

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

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    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