BEUDAMED
    10 results · 28ms · Sources: EU EUDAMED, US FDA

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    CVIS INSIGHT III SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    LID CHAIN EYELID WEIGHTS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CPS AIM Universal II Slittable Inner Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 11, 2016

    ACT ARTIC E1 HIP BRG 28X40MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWY·August 21, 2019

    BHR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS, LTD.·Product code NXT·January 18, 2013

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 6, 2014

    ATTAIN ABILITY

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·December 13, 2010

    G7 ACETABULAR LINER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code OQG·August 21, 2019

    Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·October 13, 2021