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

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    Unifine Pentips/ Unifine Pentips Plus

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ASAHI PTCA GUIDE WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE

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

    ADVANCE

    FDA Adverse Event
    Injury ·MEDTRONIC, INC·Product code DXE·September 9, 2019

    STARDRIVE SCREWDRIVER SHAFT T8 105MM

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code KWQ·September 27, 2016

    INTEGRITY AFX

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·January 13, 2014

    COLLEAGUE PRE 1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

    CAPSUREFIX MRI SURESCAN

    FDA Adverse Event
    Malfunction ·MPRI·Product code NVN·June 7, 2013

    ENVEO PRO DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 23, 2021

    ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024