BEUDAMED
    14 results · 25ms · 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 ×

    DANNIK Disposable Monopolar Laparoscopic Instrument

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

    ECHO BI-METRIC MICROPLASTY HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304697867·

    Ophthalmic Retractor

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101100·HELVESTON "GREAT BIG BARBIE" RETRACTOR 11MM

    CETRA

    FDA UDI
    Orthofix US LLC·18257200123391·4.0MM X 19MM PRIMARY CONSTRAINED SELF-TAPPING S...

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC·Product code QKP·August 17, 2022

    KJ MASK

    FDA 510(k)
    FDA Class 2 ·Dental

    ENAMELITE ACRYSEAL SPRAY SEALANT

    FDA 510(k)
    FDA Class 2 ·Dental

    DIRECT CHECK QUALITY CONTROL

    FDA Adverse Event
    Malfunction ·INTERNATIONAL TECHNIDYNE CORPORATION·Product code GGN·July 21, 2011

    FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·October 13, 2008

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·June 27, 2013

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·October 5, 2015

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·November 9, 2015

    HARMONIC ACE 36CM W ERG HANDLE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·January 30, 2018

    VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc·May 25, 2022