BEUDAMED
    14 results · 23ms · 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 ×

    ELECTRODE, CUTANEOUS

    FDA 510(k)
    FDA Class 2 ·Neurology

    SeaSpine Spacer System - Ventura™ NanoMetalene®

    FDA UDI
    Seaspine Orthopedics Corporation·10889981050146·Ventura NM Modular Inserter

    K133801

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 31, 2024

    GYNECARE X-TRACT MORCELLATOR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code HET·June 8, 2006

    BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY

    FDA 510(k)
    FDA Class 2 ·General Hospital

    KYPHX HV-R, MODEL C01A

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Injury ·KYPHON, INC.·Product code NDN·June 23, 2006

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·May 26, 2021

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 27, 2020

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Injury ·KYPHON, INC.·Product code NDN·June 20, 2006

    ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVE, INC.·Product code NPV·December 13, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 29, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 15, 2014

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023