BEUDAMED
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    Polydioxanone Surgical Scaffold

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

    CLEARJET

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

    OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TRULIANT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·July 14, 2025

    MINI-CAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·June 20, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

    REGATTA GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BRIVANT LTD.·Product code DQX·September 29, 2008

    CHROMID® CARBA SMART

    FDA Adverse Event
    Malfunction ·BIOMERIEUX S.A.·Product code JSO·August 23, 2018

    Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781347

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018