BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    TRACHEAL TUBE, REINFORCED, CUFFED

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VITROS

    FDA UDI
    ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750031801·VITROS XT Chemistry Products TBIL-ALKP Slides

    ADULT INCONTINENCE BRIEF

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    TUBE TENDER

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NKM·June 2, 2014

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    FDA Adverse Event
    Malfunction ·ALLERGAN·Product code LTI·November 8, 2012

    BLUNTPORT* BLUNT TROCAR W/ THREADED ANCHOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code GCJ·June 15, 2015

    ORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK) REAGENT.

    FDA Enforcement
    Class II ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025

    VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measures total bilirubin (TBIL) concentration in serum and plasma, Product Code: 6844296

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·September 2, 2020

    VITROS XT Chemistry Products TBIL-ALKP Slides

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, INc.·September 27, 2023

    VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measures total bilirubin (TBIL) concentration in serum and plasma, Product Code: 6844296

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CIG·July 13, 2020

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

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