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

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    TSI Transseptal Introducer

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AVANOS

    FDA UDI
    Avanos Medical, Inc.·00193493928378·AVANOS* Double Needle Set

    Halyard

    FDA UDI
    Avanos Medical, Inc.·10680651928372·

    CRANIALMAP

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613252510949·CRANIALMAP(TM) EXPRESS SALES DEMO

    8.1MHZ PENCIL PROBE 7'

    FDA UDI
    PARKS MEDICAL ELECTRONICS, INC.·00816787020908·

    MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENDOSCOPIC CLIP APPLIERS WITH CLIP MAGAZINE

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

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·February 18, 2020

    TRIFUSE

    FDA Adverse Event
    Malfunction ·ICU MEDICAL·Product code FMG·October 3, 2017

    9" SMALLBORE EXT SET W/CLAVE®, CLAMPS, ROTATING LUER

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·April 5, 2019

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·July 30, 2020

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·April 16, 2020

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·October 24, 2019

    NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 (01)06438147295708(17)180531(10)653414 (01)06438147295708(17)180531(10)653657 (01)06438147295708(17)180630(10)654923 (01)06438147295708(17)180630(10)655680 (01)06438147295708(17)180630(10)655300 (01)06438147295708(17)180630(10)654924 (01)06438147295708(17)180831(10)656025 (01)06438147295708(17)180831(10)657055 (01)06438147295708(17)180831(10)656170 (01)06438147295708(17)180831(10)656320 (01)06438147295708(17)181031(10)657768 (01)06438147295708(17)181031(10)657513 (01)06438147295708(17)181031(10)658006

    FDA Recall
    Terminated ·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code NQL·November 2, 2017

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    INVAMEX·Product code IOR·June 20, 2013

    *

    FDA Adverse Event
    Malfunction ·HOSPIRA·Product code FPB·July 25, 2011

    INTELECT MOBILE COMBO

    FDA Adverse Event
    Malfunction ·CHATTANOOGA GROUP·Product code IPF·September 23, 2008

    NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 (01)06438147295708(17)180531(10)653414 (01)06438147295708(17)180531(10)653657 (01)06438147295708(17)180630(10)654923 (01)06438147295708(17)180630(10)655680 (01)06438147295708(17)180630(10)655300 (01)06438147295708(17)180630(10)654924 (01)06438147295708(17)180831(10)656025 (01)06438147295708(17)180831(10)657055 (01)06438147295708(17)180831(10)656170 (01)06438147295708(17)180831(10)656320 (01)06438147295708(17)181031(10)657768 (01)06438147295708(17)181031(10)657513 (01)06438147295708(17)181031(10)658006

    FDA Enforcement
    Class II ·Terminated·PerkinElmer Life and Analytical Sciences, Wallac, OY·May 16, 2018

    IMPEDE-FX EMBOLIZATION PLUG

    FDA Adverse Event
    Malfunction ·SHAPE MEMORY MEDICAL INC.·Product code KRD·February 28, 2023

    IMPEDE-FX EMBOLIZATION PLUG

    FDA Adverse Event
    Malfunction ·SHAPE MEMORY MEDICAL INC.·Product code KRD·May 7, 2024