BEUDAMED
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    FASTLOK (STAPLE & BUCKLE) FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NLITE SYSTEM,MODEL A00-1025

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

    MectaLock All-Suture Anchors

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCURUS 800CS

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·January 9, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 24, 2010

    FLEXTEND II

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code DTB·July 3, 2014

    Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.

    FDA Enforcement
    Class I ·Ongoing·Mallinckrodt Manufacturing LLC·September 20, 2023

    Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.

    FDA Recall
    Open, Classified ·Mallinckrodt Manufacturing LLC·Product code BZO·August 8, 2023

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017