BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123847·K-WIRE - DOUBLE TROCAR 1.8mm DIA x 200mm

    Calibration Gas

    FDA UDI
    Radiometer Medical ApS·05700699621887·TCM4 CAL GAS

    IRRIGATION & ASPIRATION/VITRECTOMY DEVICE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    UNSPECIFIED SAFESET TRANSPAC SETS

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·January 2, 2025

    PROMUS ELEMENT¿ PLUS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·February 14, 2013

    AFX SYSTEM

    FDA Adverse Event
    Injury ·ENDOLOGIX, INC.·Product code MIH·July 28, 2014

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·January 17, 2011

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

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