BEUDAMED
    11 results · 32ms · Sources: EU EUDAMED, US FDA

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    RxSight® Insertion Device (63002)

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    PROFUSION BONE VOID FILLER KIT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DIODE LASER FOR HIAR REMOVAL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code DZE·June 12, 2024

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·April 18, 2023

    TEXIUM

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS S.A DE C.V.·Product code FMF·March 19, 2026

    PSX INTERBODY SYSTEM

    FDA Adverse Event
    Injury ·ALPHATEC SPINE, INC.·Product code MAX·April 29, 2025

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 4, 2014

    RINGLOC BI-POLAR ACETABULAR CUP 28MM I.D. / 51MM O.D.

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·September 1, 2011

    PLV-102

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·July 15, 2013

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022