BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    FLASH AR; FLASH AR QUICK

    FDA 510(k)
    FDA Class 2 ·Dental

    AGXO

    FDA UDI
    Oticon A/S·05707131262257·H110, RITE 312 WL DBL AGXO

    REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HNM LATERAL ANCHOR

    FDA Adverse Event
    Injury ·HNM STAINLESS, LLC DBA HNM MEDICAL·Product code HWC·April 16, 2018

    VALIANT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·October 1, 2014

    EXCLAIM 8

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 20, 2013

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·October 7, 2015

    VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX

    FDA Enforcement
    Class II ·Terminated·Civco Medical Instruments Co. Inc.·December 29, 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

    Philips Respironics DreamWear Full Face Mask

    FDA Enforcement
    Class I ·Ongoing·Philips Respironics, Inc.·October 12, 2022

    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