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

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    REVERSE MEDICAL MICROCATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ArgenZ HT+ 95x12 B4

    FDA UDI
    ARGEN CORPORATION, THE·D818122684·Dental porcelain/ceramic restoration kit

    BD PRECISIONGLIDE STERILE HYPODERMIC NEEDLE

    FDA Adverse Event
    Injury ·BD·Product code FMI·June 16, 2015

    XELIS DENTAL

    FDA 510(k)
    FDA Class 2 ·Radiology

    PORTABLE THERAPEUTIC OXYGEN CONCENTRATION SYSTEM (PTOCS)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    THERMACHOICE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code MNB·May 21, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 26, 2014

    ARTICULEZE M HEAD 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·June 3, 2011

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·August 1, 2023

    SAFESHEATH II 9F

    FDA Adverse Event
    Malfunction ·OSCOR INC.·Product code DYB·August 10, 2022

    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

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

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025