BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    QANS (Quantitative Autonomic Nervous System) Monitoring System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    S4 SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MULTI-CHEM CALIBRATOR A

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ELEVATE SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code MAX·July 8, 2020

    DRILL ATTACHM 45° CANN W/JACOBS CHUCK F/

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code DZI·June 3, 2013

    INRATIO PT/INR TEST STRIPS

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC.·Product code GJS·September 30, 2014

    SIMON NITINOL FILTER - JUGULAR

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·June 20, 2011

    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