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

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    EFAI ChestSuite XR Pleural Effusion Assessment System

    FDA 510(k)
    FDA Class 2 ·Radiology

    K-Systems

    FDA UDI
    Coopersurgical, Inc.·00888937025033·G95 Mini Incubator

    Bernafon

    FDA UDI
    Bernafon AG·05714464009558·BERNAFON ALPHA 7 MNR T R ANBR

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112618·BARRON CORNEAL PUNCH 7.5MM

    FIRST CHOICE & FIRST CHOICE PLUS

    FDA 510(k)
    FDA Class 2 ·Neurology

    PERSONAL HEALTH CENTER (PHC)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER - INTERNATIONAL KIT

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code GCJ·September 13, 2024

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code HQL·November 6, 2008

    3002 SECURE II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·August 16, 2011

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 3, 2014

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    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