BEUDAMED
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    HELENA COLOCARE

    FDA 510(k)
    FDA Class 2 ·Hematology

    HDS HI 1.54

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    APTIMA MULTITEST SWAB SPECIMEN COLLECTION KIT

    FDA Adverse Event
    Injury ·HOLOGIC, INC.·Product code LIO·August 9, 2024

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 10, 2014

    TITLE 2 CAP SCREW

    FDA Adverse Event
    Malfunction ·ZIMMER SPINE·Product code MNI·October 13, 2010

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    FDA Adverse Event
    Malfunction ·ACCESSCLOSURE, INC.·Product code MGB·December 20, 2012

    Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 - is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffessional who is experienced in the operation of this or similar equipment. The roller pump is used to move fluids through the cardiopulmonary bypass circuit and can be used for a number of applicatinos including arterial blood pumping, cardioplegia delivery, suction, and venting.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·February 19, 2020

    Pipeline Flex Embolization Device

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020