BEUDAMED
    10 results · 25ms · Sources: EU EUDAMED, US FDA

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    COMPUTRIM 900

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Polishers

    FDA UDI
    DFS - DIAMON GmbH·04057176147257·UPORAL C wheel brush CA, pu: 2 pcs

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·20842209110661·

    HTF-HEPES

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SURGICAL HANDPIECES, MIKRO SAW HANDPIECES

    FDA 510(k)
    FDA Class 2 ·Dental

    VALIANT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·May 8, 2014

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·October 18, 2012

    COMPRESSION ANASTOMOSIS RING CAR 27/COLONRING

    FDA Adverse Event
    Injury ·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 10, 2010

    SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·July 3, 2024

    Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·March 22, 2023