BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    THERMORITE MODEL HC-83 HYPO/HYPERTHERMIA UNIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ICS THEOPHYLLINE REAGENTS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 5, 2010

    MEDTRONIC INFUSE BONE GRAFT OR RHBMP2

    FDA Adverse Event
    Injury ·MEDTRONIC, INC·Product code NEK·November 15, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·June 18, 2015

    HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·June 12, 2024

    Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064 722222; Azurion 5 M20 722228; Azurion 7 B12 722067 722225; Azurion 7 B20 722068 722226; Azurion 7 M12 722078 722223; Azurion 7 M20 722079 722224;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024