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

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    CHLAMYDIA STAT DIRECT SMEAR COLLECTION KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668109281·SILICONE TUBING 12" (305MM)

    Medtronic Reusable Instrument

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00721902730443·INSTRUMENT 874-456 ML 14X11MMDP CTTR 6MM

    NA

    FDA UDI
    STERILMED, INC.·10888551001335·BUR CYLINDER CUTTER

    CAMPYLOBACTER BLOOD AGAR

    FDA 510(k)
    FDA Class 1 ·Microbiology

    HELENA BIO STRIP OB

    FDA 510(k)
    FDA Class 2 ·Hematology

    LOGIC KNEE COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·September 29, 2025

    SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·June 16, 2014

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES, INC.·Product code LWR·October 13, 2010

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·December 14, 2012

    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