BEUDAMED
    10 results · 29ms · Sources: EU EUDAMED, US FDA

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    MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    DENTAL ORAL CARE SYSTEMS & COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Dental

    INJECTION CAP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PORTEX

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code BTR·September 26, 2020

    PORTEX

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code BTR·September 26, 2020

    PORTEX

    FDA Adverse Event
    Injury ·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code BTR·September 25, 2020

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 16, 2014

    SETROX S 60

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·October 14, 2010

    ASAHI PROWATER PTCA GUIDE WIRE

    FDA Adverse Event
    Malfunction ·AV-ASAHI·Product code DQX·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