BEUDAMED
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    ADVIA Centaur CA 15-3 assay

    FDA 510(k)
    FDA Class 2 ·Immunology

    AccuQuest

    FDA UDI
    Bernafon AG·05711584089811·AQ CO1 MNR, 2.4G NFM PB SABE/MSIL ACCUQ

    TWISTCUT ENDOSORB SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SOL-M EXCHANGEABLE NEEDLES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MONOCRYL (POLIGLECAPRONE 25) SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAN·October 8, 2008

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 27, 2013

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NTE·August 5, 2011

    Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·April 27, 2016

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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