BEUDAMED
    11 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.

    MEDICOMP CPAP NASAL CANNULA

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PREMIER® Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074229270·PLATE 6861280 80MM FSP ANTERIOR CRV

    EndoEssentials™ Gutta Percha Points ISO#80 .02 Taper w MM Markings

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172014687·Polymer-based endodontic gutta percha

    V-2200 INFANT INCUBATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Cervical Stand Alone System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SKINTACT

    FDA Adverse Event
    Malfunction ·LEONHARD LANG GMBH·Product code MKJ·January 30, 2015

    RELIA VDD

    FDA Adverse Event
    Injury ·MEDTRONIC SINGAPORE OPERATIONS·Product code NVZ·June 10, 2014

    COATED VICRYL RAPIDE (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code GAM·October 1, 2010

    SECURE II MED/SURG BED

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

    REPLACEMENT HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·December 30, 2015

    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