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

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    FOUNDATION DENTAL RESIN

    FDA 510(k)
    FDA Class 2 ·Dental

    One Super studs

    FDA UDI
    GLOBAL PROTECTION CORP.·00726893114692·ONE SUPER STUDS 36 CT

    One Super Studs

    FDA UDI
    GLOBAL PROTECTION CORP.·00726893116863·Latex Lubricated Condom- Amazon Specific

    LAMBERGSLEEPWELL- SMARTRUSION (LSW-S)

    FDA 510(k)
    FDA Class 2 ·Dental

    UNI-GOLD STREP A TEST KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    VITEK® 2 AST-ST01 TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC·Product code LON·October 24, 2017

    URETEX SUPPORT PP TRANSOBTUR2 KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code OTN·April 10, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·September 23, 2014

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·June 2, 2011

    PANTHER FUSION ADV/HMPV/RV ASSAY

    FDA Adverse Event
    Injury ·HOLOGIC INCORPORATED·Product code OCC·October 12, 2021

    PANTHER FUSION SARS-COV-2 ASSAY PPR SOLUTION

    FDA Adverse Event
    Malfunction ·HOLOGIC INCORPORATED·Product code QJR·October 11, 2021

    Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR WITH ONE NO. 2 WHITE/BLUE HI-FI SUTURE

    FDA Adverse Event
    Malfunction ·CONMED CORPORATION·Product code MBI·April 23, 2019

    SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone.

    FDA Enforcement
    Class II ·Terminated·Monteris Medical Corp·November 26, 2014

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    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

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018