BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    APEXPRO TELEMETRY SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014605357·MAQUET 1130 SPLIT LEG 5.25" SOFTCARE PLUS

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221024824·Unitek(TM) Lingual Sheaths Slotted Tube UL/LR D...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450505533·

    SPECTRUM SILICONE FOLEY CATHETER

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

    PARAGON INFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    UNIFY CRT-D

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·April 26, 2013

    LAMITRODE 44 SURGICAL LEAD

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·April 7, 2011

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.,·Product code LKK·July 22, 2008

    ARCHITECT CYCLOSPORINE REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MKW·August 8, 2025

    ARCHITECT CYCLOSPORINE REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MKW·September 4, 2025

    ABBOTT TUBE EDTA PLH 13X75 2.0 PNK

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·August 3, 2022

    HANDLE CEV102910R DIA 10MM ANG W/RATCHET [MXI/XOM]

    FDA Adverse Event
    Injury ·XOMED MICROFRANCE MFG·Product code GCJ·December 20, 2013

    ABBOTT TUBE EDTA PLH 13X75 2.0 PNK

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·September 17, 2019

    UNK LINX MAGNETIC IMPLANT

    FDA Adverse Event
    Injury ·TORAX MEDICAL, INC.·Product code LEI·March 25, 2021

    HEARTMATE 3 LVAS IMPLANT KIT

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·December 23, 2019

    ARCHITECT CYCLOSPORINE REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MKW·September 30, 2025

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014