BEUDAMED
    13 results · 26ms · Sources: EU EUDAMED, US FDA

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    VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM

    FDA Adverse Event
    Malfunction ·CODMAN AND SHURTLEFF, INC·Product code HCG·June 15, 2017

    PIVOX™ Oblique Lateral Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169606661·SPACER 2123560 O25 23.5MM 18 DEG 16X60

    NorthStar

    FDA UDI
    Seaspine Orthopedics Corporation·10889981231736·W Parallel Top Loading to 5.5/6.0mm

    SHASER IPL HAIR REMOVAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ENVIRON-NP DISPOSABLE VINYL EXAM GLOVES, POWDERED

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SOLID SCREWDRIVER, SMALL

    FDA Adverse Event
    Malfunction ·CONVENTUS FLOWER ORTHOPEDICS·Product code HXX·August 17, 2021

    RELION PEN NEEDLES 4MM X 32 GAUGE (5/32" X 0.23MM) PEN NEEDLES 50 COUNT

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FMI·March 15, 2023

    M2A-MAGNUM MOD HD SZ 50MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 22, 2013

    ACCU-CHEK ® AVIVA COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·September 26, 2014

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·June 9, 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