BEUDAMED
    9 results · 22ms · Sources: EU EUDAMED, US FDA

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    ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AND NON-SIGHTED EYES)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Polystar Selection EDITION HD

    FDA UDI
    Merz Dental GmbH·D7091983053·posteriors; shade B2; size M; lower jaw

    EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)

    FDA 510(k)
    FDA Class 2 ·Immunology

    Olympus Small Intestinal Capsule Endoscope System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·September 12, 2016

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 16, 2014

    EXPEDIUM DRIVER

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES SPINE·Product code LXH·February 28, 2013

    UNKNOWN DEPUY ASR COMPONENTS

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD.·Product code KWA·February 4, 2011

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

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