BEUDAMED
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    Cepheid Xpert C. difficile/Epi Control Panel

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Oticon

    FDA UDI
    Oticon A/S·05707131339102·SIYA 1, MRITE 312 2.4G NFM PB C091

    PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MOJO, VERASEAL

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 21, 2014

    MERIT CUSTOM KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·June 21, 2013

    ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL·Product code FZP·July 29, 2011

    bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    FDA Enforcement
    Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018

    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

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024