BEUDAMED
    7 results · 20ms · 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.
    Filters Regulation: Us FDA ×

    Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CLINPRO PROPHY POWDER

    FDA 510(k)
    FDA Class 2 ·Dental

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 25, 2008

    FLEXCATH STEERABLE SHEATH

    FDA Adverse Event
    Malfunction ·MEDTRONIC CRYOCATH LP·Product code DRA·September 9, 2011

    EXTRACTOR F/BROKEN SCREW

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HWB·July 22, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025