BEUDAMED
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    ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MALLINCKRODT

    FDA Adverse Event
    Injury ·COVIDIEN·Product code BTR·February 26, 2014

    MULTI ADJUSTABLE FACE MASK

    FDA 510(k)
    FDA Class 2 ·Dental

    VIGIL SEROLOGY CONTROL LEVEL C

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PRECISION MONTAGE MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 2, 2018

    PROFEMUR(R) HIP STEM

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LPH·July 10, 2010

    TRIMA ACCEL

    FDA Adverse Event
    Malfunction ·TERUMO BCT·Product code GKT·May 2, 2013

    POLARIS 5.5 TITANIUM SPINAL SYSTEM

    FDA Adverse Event
    Injury ·EBI, LLC.·Product code MNI·September 15, 2014

    HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 16, 2011

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024