BEUDAMED
    34 results · 24ms · Sources: EU EUDAMED, US FDA

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    FLEXI-LITE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MaxFuse VBR, 10 (D) x 12 (W) x 37 (H)

    FDA UDI
    Pioneer Surgical Technology, Inc.·00846468055288·10 (D) x 12 (W) x 37 (H)

    SHAFT FOR 90° SCREWDRIVER

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code HWE·January 21, 2015

    IV SET AN122 W/O PUMP T-TYPE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·March 17, 2021

    MODIFICATION TO THE BOLD SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    THERMAL CAUTERY FORCEPS

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

    BD DISCARDIT II SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·May 10, 2021

    HANDLE FOR 90° SCREWDRIVER

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code HWE·January 21, 2015

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·August 2, 2019

    CG FUTURE BAND

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·October 15, 2018

    QUADRA ASSURA CRT-D, DF4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 9, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 3, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·May 24, 2011

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 10, 2021

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·October 26, 2021

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·May 16, 2023

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DYE·April 27, 2020

    HANDLE FOR 90° SCREWDRIVER

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code HWE·January 21, 2015

    SHAFT FOR 90° SCREWDRIVER

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code HWE·January 21, 2015

    Facial Pack , part number AMS6501

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017