BEUDAMED
    18 results · 38ms · Sources: EU EUDAMED, US FDA

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    NATURE-CRYL HI PLUS

    FDA 510(k)
    FDA Class 2 ·Dental

    Speedlock

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657043441·Microscissors, Extremely Delicate Tip, Shaft 5m...

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    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657046244·Atraumatic Grasper, 5mm, Single Action Handle: ...

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    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657056809·Babcock-DeBakey, 5mm Handle: 1358 Axial Thumb R...

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    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657031110·Dissector, 5mm, Serrated, Strong Curved Handle...

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    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657035958·Johan Grasping Forceps, 5mm, 22mm Slightly Flat...

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    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657024075·Fenestrated Grasping Forceps, 5mm, Slightly Fla...

    EBI XFIX DFS METAPHYSEAL CORRECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EMBRYO BIOPSY MEDIUM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Injury ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·April 7, 2011

    TAXUS® LIBERTÉ® ATOM¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·April 10, 2013

    VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAM·September 2, 2014

    PERISTEEN ANAL IRRIG SYSTEM

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code KNT·April 12, 2019

    Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

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

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022