BEUDAMED
    10 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.

    COLUMBIZ CNA AGAR W/15% SHEEP BLOOD

    FDA 510(k)
    FDA Class 1 ·Microbiology

    OVATION®

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K82055261·OVATION® Base Rx SP 022 UL/5-5 CS-BC DHK

    OVATION®

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K82055241·OVATION® Base Rx 022 UL/5-5 CS-BC MHK

    OVATION®

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K82055221·OVATION® Base Rx 022 UL/5-5 CS-BC DHK

    MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SUR-FIT NATURA 2 PC UROSTOMY POUCH WITH ACCUSEAL

    FDA Adverse Event
    Malfunction ·CONVATEC INC·Product code EXH·April 11, 2014

    RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MAKO SURGICAL·Product code NPJ·October 26, 2012

    MEDPOR IMPLANT

    FDA Adverse Event
    Injury ·POREX SURGICAL·Product code FTM·August 26, 2010

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021