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

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    VERTEBRACE SPINAL SUPPORTS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    VuePoint

    FDA UDI
    Nuvasive, Inc.·00887517338082·VuePoint Screw, 3.5x14mm Multi Axial

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690199045·AK3 Congruent Insert Trial Size 3, 14mm

    SYNCHRON® AMYLASE (AMY) REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JFJ·September 21, 2010

    FLEXION-BRAKING KNEE-SHIN ASSEMBLY

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 5, 2014

    CAPSUREFIX NOVUS MRI

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code NVN·October 15, 2012

    INSYNC III MARQUIS

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code NIK·August 10, 2010

    PROPONENT DR SL (Model L201)

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