BEUDAMED
    9 results · 19ms · 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 ×

    Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL

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

    num Vapocoolant

    FDA 510(k)
    FDA Unclassified ·Unknown

    FLUENT FLUID MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·HOLOGIC, INC.·Product code HIG·March 29, 2022

    TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM

    FDA Adverse Event
    TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code GCJ·August 9, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 4, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 12, 2013

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020