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

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    WEXLER ENDOSCOPE ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Kwire tip protector Dia 1.2/1.6 mm sterile

    FDA UDI
    IN2BONES·03760225714775·Kwire tip protector Dia 1.2/1.6 mm sterile

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776180034·Peers Towel Fcps

    MYSTIQUE® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K110151101·MYSTIQUE® MB RT RX 018 U 5-5 CS HK

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450158319·

    MODEL 300157 CPAP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    STERILE BUTTON PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Widex

    FDA UDI
    Widex A/S·05706069716320·Widex EVOKE E-FM (Titanium grey ) 110, RC coil

    Widex

    FDA UDI
    Widex A/S·05706069884227·WIDEX MOMENT MRR2D (Titanium grey ) 110, RC coi...

    Widex

    FDA UDI
    Widex A/S·05706069852066·WIDEX MOMENT MBB3D 110 (Titanium grey)

    Widex

    FDA UDI
    Widex A/S·05706069715910·Widex EVOKE E-FP (Titanium grey ) 110, Telecoil...

    Widex

    FDA UDI
    Widex A/S·05706069971934·WIDEX MOMENT MBB2 110 (Titanium grey)

    Widex

    FDA UDI
    Widex A/S·05706069715583·Widex EVOKE E-FA (Titanium grey ) 110, Telecoil...

    20G X 1.16IN (1.1 X 30 MM) W/ Y INTIMA II

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·December 6, 2019

    MAXCEM ELITE

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EMA·May 13, 2013

    HX2 TEMPERATURE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·September 11, 2014

    MOTOR ADVANCE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·May 19, 2011

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·August 25, 2011

    VIDAS SARS-COV-2 IGG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code QKO·February 18, 2021

    Ingenia 1.5T and 3.0T MRI Systems, Model Numbers: 781396 and 781377, 510(k) #K110151. System units equipped with software version: 4.1.1 are subject to recall/field correction. This MRI system is indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities. Image appearance is determined by the spatial distribution and flow as well as by many different NMR related properties of the tissue and anatomy studied and the MRI scan technique applied. These images and/or spectra, when interpreted by a trained physician, provide information that may assist the diagnosis.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code LNH·August 3, 2011