BEUDAMED
    13 results · 11ms · 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 Status: Terminated ×

    E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit

    FDA Enforcement
    Class I ·Terminated·E25Bio, Inc.·February 16, 2022

    Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

    FDA Enforcement
    Class I ·Terminated·Abbott Molecular, Inc.·October 20, 2021

    DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 00190446683667 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

    FDA Enforcement
    Class II ·Terminated·DJ Orthopedics de Mexico S.A. de C.V.·May 5, 2021

    Sterile Custom Packs to be used in surgical procedures.

    FDA Enforcement
    Class II ·Terminated·American Contract Systems·June 10, 2020

    BioGlue Surgical Adhesive, Model BG3510-5-G

    FDA Recall
    Terminated ·CryoLife, Inc.·Product code MUQ·October 7, 2021

    Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component.

    FDA Recall
    Terminated ·Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom·Product code MEH·May 6, 2021

    Corin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS, REF 6961007. Hip prosthesis component.

    FDA Recall
    Terminated ·Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom·Product code MEH·May 6, 2021

    GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860

    FDA Recall
    Terminated ·Vero Biotech, LLC·Product code MRN·May 19, 2021

    Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for medical purposes and is used to assist a disabled person to move from one place to another while sitting. Intended to be used by persons up to 95 pounds for transport.

    FDA Recall
    Terminated ·Ki Mobility Llc·Product code INM·November 19, 2021

    Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.

    FDA Recall
    Terminated ·Technomed Europe Amerikalaan 71 Maastricht-Airport Netherlands·Product code GXZ·December 8, 2021

    Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

    FDA Recall
    Terminated ·NOX MEDICAL Keldnaholt Reykjavik Iceland·Product code MNR·September 7, 2021

    reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.

    FDA Recall
    Terminated ·Pear Therapeutics, Inc.·Product code PWE·June 7, 2021

    reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.

    FDA Recall
    Terminated ·Pear Therapeutics, Inc.·Product code PWE·June 7, 2021