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

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    KOWA NONMYD WX

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383502016·Gutta Percha Points is used to root canal filin...

    NAMBUCCA Anterior Lumbar Plate Screw

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215019969·

    PLASMALUXLS

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

    CONCORD 82

    FDA 510(k)
    FDA Class 2 ·Dental

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·ACUMED LLC·Product code HRS·December 18, 2019

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·ACUMED LLC·Product code HRS·December 18, 2019

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·ACUMED LLC·Product code HRS·December 18, 2019

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·March 1, 2023

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 11, 2011

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 23, 2013

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 19, 2014

    SOLITAIRE FR

    FDA Adverse Event
    Injury ·COVIDIEN (IRVINE)·Product code NRY·June 29, 2017

    GALAXY G3 MINI 2MM X 4CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021

    GALAXY G3 5MM X 15CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021

    GALAXY G3 MINI 3MM X 8CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021

    GALAXY G3 MINI 2MM X 3CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025