BEUDAMED
    10 results · 28ms · 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.

    CURITY URETERAL STENT

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

    POST-AURICULAR HEARING AID MODEL PE 600PPCH

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    MCDB 302 MEDIUM, M2021

    FDA 510(k)
    FDA Class 1 ·Hematology

    REVEAL XT

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code DSI·October 5, 2010

    ENSEAL G2 STRAIGHT JAW

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GEI·December 3, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 18, 2015

    UNK - CAGE/SPACERS: T-PAL

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code MAX·March 4, 2022

    UNK - CAGE/SPACER: CONCORDE

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code MAX·March 4, 2022

    UNKNOWN ENDO GIA SULU

    FDA Adverse Event
    Injury ·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·July 22, 2022

    Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: FlexViewing PC Azurion Model Name - Model Number: Azurion 7 B12 722067; Azurion 7 B20 722068; Azurion 7 M12 722078 722223; Azurion 7 M20 722079;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024