BEUDAMED
    10 results · 36ms · Sources: EU EUDAMED, US FDA

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    ALPHALOK™ Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517569325·CoRoent Ant TLIF Ti, 11x12x34mm 8°

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113370·CLEAR CORNEA KNIFE 3.2MM (BX/5)

    RS-4I MUSCLE STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MAXIM RPG PS FEMORAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·October 29, 2008

    GATEWAY BALLOON CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code GBA·August 15, 2011

    ACCU-CHEK FLEXLINK/ULTRAFLEX TRANSFER SET

    FDA Adverse Event
    Malfunction ·ROCHE HEALTH SOLUTIONS, INC·Product code FPA·July 9, 2013

    Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021