BEUDAMED
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    Upper Arm Blood Pressure Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Oticon

    FDA UDI
    Oticon A/S·05707131339560·SIYA 1, KIT 312 2.4G NFM 75 L C001

    HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TEMPORARY C&B COMPOSITE

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 22, 2025

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·CORDIS NEUROVASCULAR, INC.·Product code NJE·October 1, 2008

    SCRDRIVERSHAFT-3.5-HEX L180

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HXX·June 26, 2013

    ALARIS

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FRN·July 22, 2011

    THORATEC® HEARTMATE II®, SYSTEM CONTROLLER

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·December 2, 2024

    Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001

    FDA Enforcement
    Class II ·Ongoing·Cook Vandergrift, Inc.·September 13, 2023