BEUDAMED
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    SUREONE INSULIN SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964020801·Endo Carry-On Procedure Kit

    MEDTRONIC EXTENDED INFUSION SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 25, 2024

    BAYER ADVIA IMS SYSTEM; 200 + 3

    FDA 510(k)
    FDA Class 2 ·Immunology

    WAKO AUTOKIT LP(A)/EXPRESS 550

    FDA 510(k)
    FDA Class 2 ·Immunology

    DREAMTOME¿ RX 44

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - SPENCER·Product code KNS·March 13, 2013

    PINNACLE MTL INS NEUT40IDX56OD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 16, 2011

    ICY HOT HEAT THERAPY PATCH

    FDA Adverse Event
    Other ·CHATTEM, INC.·Product code IMD·February 8, 2008

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NPT·November 10, 2025

    INSYTE AUTOGUARD PNK 20GA X 1.16IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·May 20, 2019

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024