BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    Wave Electrode (AE02-60); Wave Electrode (AE02-50)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113349·PHACO KNIFE 3.2MM ANGLED (BX/5)

    242326

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code FCW·April 8, 2020

    242326

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code FCW·January 16, 2020

    ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    HP Tissue Matrix

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

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code LWR·November 20, 2008

    ACCESS® 2 IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·September 10, 2011

    NC QUANTUM APEX?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·July 23, 2013

    IMGMGMNT PHOTOVIDEO SYSTEM 4K MONITOR

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SàRL·Product code FCW·December 18, 2019

    Alcon Custom Ophthalmic Surgical Procedure Packs

    FDA Enforcement
    Class II ·Terminated·Alcon Research, LLC·April 7, 2021

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023