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

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    REVERSE SHOULDER PROSTHESIS MONOBLOCK HEMI ADAPTER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MAXCUT CARBIDE BUR (10/pk) FGSU # 1557

    FDA UDI
    SCOTT'S DENTAL SUPPLY L.L.C.·D77811117351·MAXCUT CARBIDE BUR (10/pk) Shape: Round; Size: ...

    TANDA MAX OTC SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DRIVER; SIZE 10

    FDA Adverse Event
    Malfunction ·K2M, INC.·Product code LXH·July 12, 2022

    MONOSYN VIOLET 5/0 (1) 70CM HR17 (M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·December 11, 2019

    GEMSTAR PAIN MGE SNG

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 7, 2013

    BIOMET BIOCHILL

    FDA Adverse Event
    Injury ·EBI, LLC·Product code ILO·June 2, 2011

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 12, 2008

    MONOSYN VIOLET 6/0 (0.7) 70CM HR13 (M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·December 11, 2019

    HYPERFORM LINE EXTENSION

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code MJN·October 30, 2023

    PREMILENE 3/0 (2) 75CM DS24 (M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAW·December 11, 2019

    MONOSYN VIOLET 5/0 (1) 70CM HR17 (M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·December 11, 2019

    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

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024