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

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    Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ID NOW COVID-19 2.0 TEST KIT 24T OUS

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 25, 2023

    ID NOW COVID-19 2.0 TEST KIT 24T OUS

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 25, 2023

    PEREGRINE 23GA CURVED LASER PROBE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 14, 2025

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL CO.·Product code HQL·November 6, 2008

    AURA XP LASER SYSTEM

    FDA Adverse Event
    Malfunction ·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·August 10, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 12, 2013

    ID NOW COVID-19 2.0 TEST KIT 24T OUS

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 25, 2023

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025