BEUDAMED
    15 results · 21ms · 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 ×

    Shear Wave Quantificational Ultrasound Diagnostic System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Malibu™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981028190·OFFSET HOOK 5.5 X 9.5mm RIGHT. The Malibu syste...

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668109069·ROSENWASSER DALK CANNULA 27GA

    SACRO-ILIAC SCREW SYSTEM SI-JOINT SCREW 10X55

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code OUR·October 8, 2019

    NEXUS RMGI

    FDA 510(k)
    FDA Class 2 ·Dental

    ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    DISCOVERY RF180

    FDA Adverse Event
    Injury ·GENERAL MEDICAL MERATE S.P.A.·Product code JAA·August 2, 2023

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Injury ·DEXCOM, INC.·Product code MDS·June 17, 2013

    CNS-6201

    FDA Adverse Event
    Malfunction ·Product code MHX·September 10, 2014

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·July 23, 2011

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·December 10, 2024

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·January 5, 2023

    SACRO-ILIAC SCREW SYSTEM SI-JOINT SCREW 10X40

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code OUR·February 5, 2021

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025