BEUDAMED
    24 results · 23ms · Sources: EU EUDAMED, US FDA

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    APEX ARC HIP STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NEO UL Anterior Cervical Plate System

    FDA UDI
    Life Spine, Inc.·00190837044848·Fixed 15 deg Angled Drill Guide

    Gibralt

    FDA UDI
    Choice Spine, LP·00840996169943·GIBRALT,CONNECTOR,H2H,C-CONNECT,32-42

    REDSENSE-ALARM UNIT AND SENSOR

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

    AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM

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

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 8, 2013

    FRESENIUS 2008K

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·September 2, 2014

    CODMAN HAKIM

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON COMPANY·Product code JXG·May 26, 2011

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·October 30, 2018

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    NEEDLE, HYPODERMIC, SINGLE LUMEN

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·September 1, 2020

    TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·August 28, 2018

    NEEDLE, HYPODERMIC, SINGLE LUMEN

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·November 8, 2019

    EVOLUT R TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·December 9, 2020

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·July 19, 2021

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO. Intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter.

    FDA Enforcement
    Class II ·Terminated·St. Jude Medical·November 20, 2013

    FLEXI SEAL SIGNAL (FMS)

    FDA Adverse Event
    Injury ·CONVATEC INC.·Product code KNT·October 11, 2016

    TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·November 13, 2018

    SURGUARD3 SAFETY HYPODERMIC NEEDLE

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·December 6, 2024