BEUDAMED
    11 results · 29ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Oticon

    FDA UDI
    Oticon A/S·05707131256416·NERA, BTE 13 WL 85 SIL

    PIONEER PLUS CATHETER, MODEL PLUS 120

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM

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

    CANTATA 2.9 SUPERSELECTIVE MICROCATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·September 14, 2017

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2014

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·AVENT S. DE R.L. DE C.V.·Product code HEB·May 29, 2013

    SPRINT

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code LWS·June 16, 2011

    FUSION 8MM-40CM UNSUPP PERIPHERAL GRAFT

    FDA Adverse Event
    Malfunction ·MAQUET CV·Product code DSY·February 8, 2017

    BD¿ NEXIVA SINGLE PORT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 21, 2019

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019