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

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    SYNCHRON MULTI CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Utrecht Interstitial Fletcher CT/MR Applicator

    FDA UDI
    Nucletron B.V.·08717213034402·Interstitial Ovoid (left) 30mm 15°, R10

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1100510·Caddie, 5.5mm Screws

    MYSTIQUE® MB

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

    GeniLook

    FDA UDI
    GENICON, INC.·00877972002628·

    Natura

    FDA UDI
    GENICON, INC.·00877972005773·

    CONMED

    FDA Adverse Event
    Malfunction ·CONMED CORPORATION·Product code LKF·January 5, 2012

    CONMED

    FDA Adverse Event
    Malfunction ·CONMED CORPORATION·Product code LKF·January 5, 2012

    IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN

    FDA 510(k)
    FDA Class 2 ·Immunology

    G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333

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

    DELTAFILL10 6MM X 16CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·October 5, 2021

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·May 13, 2013

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE REHABILITATION EQUIP·Product code ITI·September 23, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 1, 2011

    VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR

    FDA Adverse Event
    Injury ·CONMED CORPORATION·Product code LKF·September 26, 2012

    HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

    VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR

    FDA Adverse Event
    Malfunction ·CONMED CORPORATION·Product code LKF·February 10, 2012

    VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR

    FDA Adverse Event
    Malfunction ·CONMED CORPORATION·Product code LKF·February 10, 2012

    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

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016