BEUDAMED
    12 results · 23ms · 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.
    Filters Regulation: Us FDA ×

    MEDISYSTEMS TRANSDUCER PROTECTOR

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

    Polystar Selection EDITION HD

    FDA UDI
    Merz Dental GmbH·D7091983076·posteriors; shade C1; size M; upper jaw

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471130487·K-WIRE - DOUBLE TROCAR WITH GUIDE 0.7mm DIA x 1...

    STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836

    FDA 510(k)
    FDA Class 2 ·Neurology

    GRAM NEGATIVE & GRAM POSITIVE MIC/COMBO PANELS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ARCHITECT CREATINE KINASE

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code CGS·July 21, 2018

    ARCHITECT CREATINE KINASE

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code CGS·July 21, 2018

    ARCHITECT CREATINE KINASE

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code CGS·July 21, 2018

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·February 28, 2013

    UNIVERSAL FEM SLV DIS POR 34MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·February 4, 2011

    ESSURE

    FDA Adverse Event
    Injury ·BAYER·Product code HHS·August 6, 2014

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024