BEUDAMED
    12 results · 22ms · 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.
    Filters Regulation: Us FDA ×

    Avance Solo Negative Pressure Wound Therapy (NPWT) System

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

    ACCESS TOTAL T4 ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LIFECARE COMPACT TENS DEVICE

    FDA 510(k)
    FDA Class 2 ·Neurology

    BD PRN ADAPTER

    FDA Adverse Event
    Malfunction ·BD SUZHOU (MDS)·Product code FMG·January 15, 2026

    PRN ADAPTER

    FDA Adverse Event
    Malfunction ·BD SUZHOU (MDS)·Product code FMG·May 1, 2026

    PTCA CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code LOX·October 15, 2008

    CONCERTO CRT-D DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 2, 2013

    ANIMAS VIBE SYSTEM

    FDA Adverse Event
    Death ·DEXCOM, INC.·Product code OYC·February 19, 2016

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021