BEUDAMED
    9 results · 22ms · 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.

    SPINE COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613154281022·BONE SCREW, EMERGENCY, CROSS-PIN, MP

    ML24000 UVA-1 PHOTOTHERAPY UNIT

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

    ORTHOSCAN MOBILE DI MINI C-ARM

    FDA 510(k)
    FDA Class 2 ·Radiology

    8110 ALARIS SYRINGE PUMP

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·December 17, 2020

    VISISTAT 35W 6/BOX

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code GDT·May 14, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·September 26, 2014

    CAPSURE Z NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 14, 2011

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024