BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    POSEY BED

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PIVOX™ Oblique Lateral Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169605411·SPACER 2113355 OLIF25 20MM 18 DEG 12X55

    CapSure® Spine System

    FDA UDI
    Spine Wave, Inc.·10840642104578·PS3 Screw 10.5mm x 55mm

    GDC 360 DETEACHABLE COIL

    FDA 510(k)
    FDA Class 2 ·Neurology

    SPARC SLING SYSTEM

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

    NOVOSYN VIOLET 2/0 (3) 70CM HRC20S (M)

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL S.A.·Product code GAM·September 9, 2015

    MONOPLUS VIOLET 0 (3.5) 70CM HR375 (M)

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL S. A.·Product code NEW·February 7, 2014

    DEPTH ELECTRODE

    FDA Adverse Event
    Malfunction ·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·December 14, 2021

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 15, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014

    PFCSIG POSTLIP INSERT SZ3 8MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·May 20, 2011

    SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS

    FDA Adverse Event
    Injury ·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·June 14, 2019

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC EUROPE SARL·Product code MHY·September 18, 2017

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·August 17, 2023

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·April 8, 2025

    TI-SU03 GC

    FDA Adverse Event
    Injury ·NAKANISHI INC. (NSK)·Product code EFB·May 26, 2015

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021