BEUDAMED
    15 results · 26ms · 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 ×

    Non-contact infrared body thermometer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SCENARIA WHOLE-BODY X-RAY CT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES

    FDA 510(k)
    FDA Class 2 ·Dental

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014

    SOLUSET 100X60W/CAI

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·June 7, 2013

    BREAST IMPLANT

    FDA Adverse Event
    Injury ·SURGITEK·Product code FWM·September 8, 2006

    BINAXNOW¿ COVID-19 ANTIGEN SELF TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 13, 2022

    HAMMER

    FDA Adverse Event
    Malfunction ·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code LXH·February 11, 2020

    BINAXNOW¿ COVID-19 ANTIGEN SELF TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 13, 2022

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 21, 2022

    PERFORMER MULLINS GUIDING SHEATH

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·January 20, 2023

    PERFORMER MULLINS GUIDING SHEATH

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·January 24, 2024

    HAMMER

    FDA Adverse Event
    Malfunction ·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code MAX·February 11, 2020

    PERFORMER INTRODUCER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·November 4, 2022

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025