BEUDAMED
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    LARYNGECTOMY TUBE, CUFFED

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    P.F.C.

    FDA UDI
    DEPUY (IRELAND)·10603295215547·P.F.C. MODULAR PLUS TIBIAL FULL WEDGE CEMENTED ...

    EL-ACL SCREEN; EL-ACL IGM, IGG, IGA

    FDA 510(k)
    FDA Class 2 ·Immunology

    Signia Stapler

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

    PFC MOD PL TB WDG HEMI-10D SZ3

    FDA Adverse Event
    Malfunction ·DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·January 30, 2004

    MAXIMO II CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014

    DAVOL SILICONE ROUND SINGLE DRAIN

    FDA Adverse Event
    Malfunction ·PROCUCTOS PARA EL CUIDADO DE LA SALUD·Product code GBX·November 21, 2012

    NEXGEN ROTATING HINGE KNEE SCREW DRIVER

    FDA Adverse Event
    Malfunction ·ZIMMER INC.·Product code HXX·September 21, 2010

    Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·October 1, 2025

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012