BEUDAMED
    11 results · 27ms · Sources: EU EUDAMED, US FDA

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    IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS

    FDA 510(k)
    FDA Class 2 ·Immunology

    Polystar Selection EDITION

    FDA UDI
    Merz Dental GmbH·D7091982100·posteriors; shade C4; size M; upper jaw

    Instrument Case

    FDA UDI
    KATENA PRODUCTS, INC.·00841668111000·INSTRUMENT CADDY SMALL

    ALLTECH ECHOSTAR 1.5 T MR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Smile Makers Personal Lubricant

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 8, 2013

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code LGD·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

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·July 19, 2024

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·December 26, 2023

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

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