BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    MR VESSELLQ XPRESS

    FDA 510(k)
    FDA Class 2 ·Radiology

    ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    HEMOSIL PROTEIN S ACTIVITY ASSAY

    FDA 510(k)
    FDA Class 2 ·Hematology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 17, 2021

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 12, 2010

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 12, 2010

    ARIS TRANS-OBTURATOR KIT

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code FTL·May 21, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 13, 2011

    CURASALT DSG KERLIX S/S 6X6.75

    FDA Adverse Event
    Malfunction ·TYCO HEALTHCARE/KENDALL·Product code NAB·August 14, 2008

    SOMATOM Edge Plus-Computed tomography system Model 1026700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022

    SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021

    Allura Xper FD20/20; System Code: 722038;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026