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

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    RESTORELLE POLYPROPYLENE Y MESH

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

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517636089·CoRoent Ant TLIF PEEK, 11x12x32mm 12°

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04047872673143·LEVAMED STABILI-TRI ANK SUP BLU L II

    STINGRAY CERVICAL CAGE; SHARK IMPLANT (PLIF); BULL SHARK IMPLANT(PLIF); TIGER IMPLANT (TLIF); GREAT WHITE IMPLANTS(ALIF)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OPTIBOND 2

    FDA 510(k)
    FDA Class 2 ·Dental

    JDEVOLUTION PLUS

    FDA Adverse Event
    Injury ·J DENTAL CARE SRL·Product code DZE·September 12, 2025

    BIPOL LEAD MODEL 300

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·May 14, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 23, 2014

    APPOSE ULC 35 WIDE SKIN STAPLER

    FDA Adverse Event
    Injury ·NELLCOR PURITAN BENNETT·Product code GDT·May 25, 2011

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·April 1, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·April 1, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·August 8, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·July 2, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·May 2, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·PFIZER, INC.·Product code QJR·May 8, 2023

    FLEXI SEAL SIGNAL (FMS)

    FDA Adverse Event
    Injury ·CONVATEC INC.·Product code KNT·October 11, 2016

    SENSATION PLUS 8FR. 50CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·May 10, 2022

    SENSATION PLUS 7.5FR. 40CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 23, 2021

    SENSATION 7FR. 34CC IAB

    FDA Adverse Event
    Death ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 2, 2021

    CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular, LLC·January 16, 2013