BEUDAMED
    14 results · 27ms · 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.

    MINIFLEX AND PERSONAL UNIT

    FDA 510(k)
    FDA Class 1 ·Dental

    VITROS

    FDA UDI
    ORTHO CLINICAL DIAGNOSTICS·10758750000227·VITROS Immunodiagnostic Products TSH Reagent Pack

    COLLATEK FOAM

    FDA 510(k)
    FDA Unclassified ·Unknown

    HD-IVUS ULTRASOUND IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    PORTEX® BIVONA® AIRE-CUF® ADULT TRACHEOSTOMY TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD INC.·Product code JOH·September 1, 2016

    PORTEX® BIVONA® AIRE-CUF® ADULT TRACHEOSTOMY TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD INC.·Product code JOH·September 1, 2016

    HEMOSTATIX

    FDA Adverse Event
    Malfunction ·HEMOSTATIX MEDICAL TECHNOLOGIES, LLC.·Product code GEI·January 8, 2013

    COLLEAGUE COLOR PUMP CE FRENCHVERSION SINGLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·December 2, 2010

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 3, 2014

    VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997

    FDA Recall
    Open, Classified ·Ortho Clinical Diagnostics Inc·Product code JLW·July 12, 2018

    VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997

    FDA Enforcement
    Class II ·Ongoing·Ortho Clinical Diagnostics Inc·October 10, 2018

    VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227, IVD --- Ortho-Clinical Diagnostics Pencoed Bridgend CF35 5PZ UK For the in vitro quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.

    FDA Enforcement
    Class III ·Terminated·ORTHO-CLINICAL DIAGNOSTICS·August 24, 2016

    VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227, IVD --- Ortho-Clinical Diagnostics Pencoed Bridgend CF35 5PZ UK For the in vitro quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.

    FDA Recall
    Terminated ·ORTHO-CLINICAL DIAGNOSTICS FELINDRE MEADOWS Bridgend United Kingdom·Product code JLW·July 28, 2016

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024