BEUDAMED
    11 results · 18ms · Sources: EU EUDAMED, US FDA

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    STONE DISLODGER

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

    iNSitu™ Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127026720·Shortened Dual Taper Broach, Size 8

    INTRA-AORTIC BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·May 22, 1998

    SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DIGITAL LIGHTBOX

    FDA 510(k)
    FDA Class 2 ·Radiology

    BREEZE2

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·May 8, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2012

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code NBW·September 7, 2007

    ACIST" BRACCO, AT P54 AngioTouch Kit , SKU # 014644, Sterile EO Manufacturer; ACTB Medical Systems, Inc. 7905 Fuller Road, Eden Prairie, MN 55344, Made in Mexico. Catalogue No: 800608-013 Intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

    FDA Recall
    Terminated ·Acist Medical Systems·Product code DXT·June 6, 2008

    ACCOLADE SR SL MRI (Model L310)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023