BEUDAMED
    9 results · 16ms · Sources: EU EUDAMED, US FDA

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    EMERSON THORACIC SUCTION REG. #55-JP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209133529·

    Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum

    FDA Pre-Market Approval
    FDA Class 3 ·AFP MID-PREGNANCY REFERENCE PREPARATION

    COMED K-SERIES MANUAL WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX

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

    SOFTHEAT

    FDA Adverse Event
    Other ·KAZ USA, INC.·Product code IRT·May 12, 2014

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·November 6, 2012

    TERUMO CENTRIFUGAL SYSTEM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWA·August 24, 2010

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021