BEUDAMED
    29 results · 23ms · Sources: EU EUDAMED, US FDA

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    WAVEGUARD (TM) EEG CAP

    FDA 510(k)
    FDA Class 2 ·Neurology

    Unimed

    FDA UDI
    Unimed Medical Supplies, Inc.·06936735456529·Reusable Pediatric Finger Clip Spo2 Sensor Bioc...

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707097457·BKT 23 INTERACTIVE SL 22 T-7 A+8 BH

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450159941·

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K1102250·Tray, Base, 2.25", Universal

    BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·February 6, 2014

    PRISMAFLEX

    FDA Adverse Event
    Death ·GAMBRO LUNDIA AB·Product code KDI·April 11, 2014

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·November 2, 2012

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·February 15, 2012

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·December 23, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 13, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·May 20, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 14, 2008

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·February 6, 2014

    PRISMAFLEX

    FDA Adverse Event
    Death ·GAMBRO LUNDIA AB·Product code KDI·January 10, 2014

    PRISMAFLEX

    FDA Adverse Event
    Death ·GAMBRO LUNDIA AB·Product code KDI·January 3, 2014

    Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

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

    PRISMAFLEX

    FDA Adverse Event
    GAMBRO LUNDIA AB·Product code KDI·February 6, 2014