BEUDAMED
    22 results · 21ms · Sources: EU EUDAMED, US FDA

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    HEMOSIL D-DIMER HS

    FDA 510(k)
    FDA Class 2 ·Hematology

    ZAVATION

    FDA UDI
    Zavation LLC·00842166120433·PLIF-C Ti 9x27 Convex -15

    ZAVATION

    FDA UDI
    Zavation LLC·00842166120419·PLIF-C Ti 9x27 Convex -13

    ZAVATION

    FDA UDI
    Zavation LLC·00842166120426·PLIF-C Ti 9x27 Convex -14

    ZAVATION

    FDA UDI
    Zavation LLC·00842166120396·PLIF-C Ti 9x27 Convex -11

    ZAVATION

    FDA UDI
    Zavation LLC·00842166120389·PLIF-C Ti 9x27 Convex -10

    ZAVATION

    FDA UDI
    Zavation LLC·00842166120372·PLIF-C Ti 9x27 Convex -9

    ZAVATION

    FDA UDI
    Zavation LLC·00842166120402·PLIF-C Ti 9x27 Convex -12

    ZAVATION

    FDA UDI
    Zavation LLC·00842166120440·PLIF-C Ti 9x27 Convex -16

    ZAVATION

    FDA UDI
    Zavation LLC·00842166120365·PLIF-C Ti 9x27 Convex -8

    MODIFICATION TO PROLITE PULSED LIGHT SYSTEM

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

    ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4

    FDA 510(k)
    FDA Unclassified ·Unknown

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 25, 2024

    VERCISE GEVIA?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code NHL·April 16, 2025

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 22, 2013

    MTS ANTI-IGG GEL CARD

    FDA Adverse Event
    Injury ·MICROTYPING SYSTEMS·Product code KSZ·April 27, 2011

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES, INC.·Product code LWR·July 8, 2008

    KYPHON KURVE BONE FILLER DEVICE 13GA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO·Product code KIH·July 14, 2020

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022