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

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    TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MAXCUT CARBIDE BUR (10/pk) FGSU # 8

    FDA UDI
    SCOTT'S DENTAL SUPPLY L.L.C.·D77811117231·MAXCUT CARBIDE BUR (10/pk) Shape: Round; Size: ...

    COMPACT WHEELCHAIR PLATFORM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ANTI-SNORING DEVICE OR ASD

    FDA 510(k)
    FDA Class 2 ·Dental

    150 MICRON TFL BALL TIP SINGLE USE FIBER

    FDA Adverse Event
    Malfunction ·GYRUS ACMI, INC.·Product code GEX·June 30, 2023

    PELVICOL 4 X 12 CM

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TISSUE·Product code FTL·April 10, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 2, 2011

    ACUVUE OASYS WITH HYDRACLEAR

    FDA Adverse Event
    Injury ·VISTAKON·Product code LPL·August 14, 2008

    SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM

    FDA Adverse Event
    Malfunction ·GYRUS ACMI, INC.·Product code GEX·June 30, 2023

    BD PYXIS¿ ANESTHESIA STATION ES

    FDA Adverse Event
    Malfunction ·CAREFUSION 303, INC.·Product code BRY·July 17, 2025

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER 22 G X 1 IN.

    FDA Adverse Event
    Injury ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 24, 2015

    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