BEUDAMED
    42 results · 27ms · Sources: EU EUDAMED, US FDA

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    Bioscope Neuromonitor Device

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    DD Bio ZX² color

    FDA UDI
    Dental Direkt GmbH·EDDIG2330011·DD Bio ZX² are dental mill blanks made from zir...

    6PW - CPRotector® ONE Deluxe - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588030012·6PW - CPRotector® ONE Deluxe - Poly White

    IdentiTi

    FDA UDI
    ALPHATEC SPINE, INC.·00190376366999·IdentiTi ALIF SA, Impact Cap

    Sensor, Synchony

    FDA UDI
    Synapse Biomedical, Inc.·00852184003663·Stimulator, Neuromuscular, External Functional

    Innomed, Inc.

    FDA UDI
    INNOMED, INC.·00840277103444·Meniscus Rasp 2.7 End Cutting 15 Down

    Procedure Mask, Surgical Mask

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

    APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4

    FDA 510(k)
    FDA Class 2 ·Radiology

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    FDA Adverse Event
    Death ·HEARTWARE, INC.·Product code DSQ·January 29, 2020

    NA

    FDA UDI
    Zimmer, Inc.·00889024022171·

    PIRANHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code FCL·March 18, 2024

    BIPOL LEAD MODEL 300

    FDA Adverse Event
    Malfunction ·LIVANOVA USA, INC.·Product code LYJ·June 3, 2021

    INGEVITY?+

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NVN·May 4, 2025

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014

    SECURE 3 MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·July 25, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 18, 2013

    ORBERA INTRAGASTRIC BALLOON SYSTEM

    FDA Adverse Event
    Injury ·APOLLO ENDOSURGERY, INC·Product code LTI·May 16, 2024

    PULSE GEN MODEL 106

    FDA Adverse Event
    Injury ·LIVANOVA USA, INC.·Product code MUZ·February 3, 2021

    METRX SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·April 16, 2024

    SPACEOAR VUE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OVB·April 22, 2024