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

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    ALM PRISMALIX (PRX) SURGICAL LIGHT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Polystar Selection EDITION

    FDA UDI
    Merz Dental GmbH·D7091982063·posteriors; shade B3; size S; lower jaw

    VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PRELUDE SHORT SHEATH INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LOGIC FEMORAL PS CEM RIGHT SZ 3.5

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·June 9, 2023

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE HEALTH SOLUTIONS INC.·Product code LZG·February 8, 2013

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code LFX·February 8, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

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

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024