BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    STOPCOCKS, MANIFOLDS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Tina-quant Transferrin ver.2 (urine application)

    FDA 510(k)
    FDA Class 2 ·Immunology

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·March 18, 2020

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·April 30, 2014

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Injury ·COOK, INC.·Product code DQY·October 3, 2012

    HARMONIC ACE 36 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code LFL·February 12, 2008

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026