BEUDAMED
    10,000 results · 49ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    GX-C CEPHALOMETER

    FDA 510(k)
    FDA Class 2 ·Dental

    Gendex GXC-300™ intraoral camera

    FDA UDI
    GENDEX CORP.·EKAV082243310·Digital intraoral camera

    Gendex GXC-300™ intraoral camera

    FDA UDI
    GENDEX CORP.·EKAV100719700·Digital intraoral cameraDigital intraoral camera

    Gendex GXC-300™ intraoral camera sheaths

    FDA UDI
    GENDEX CORP.·EKAV082225320·500 Count

    Gendex GXC-300™ intraoral camera sheaths

    FDA UDI
    GENDEX CORP.·EKAV082226450·100 Count

    Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.

    FDA Enforcement
    Class II ·Terminated·Karl Storz Endoscopy·April 8, 2020

    Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.

    FDA Recall
    Terminated ·Karl Storz Endoscopy·Product code EQN·December 6, 2019

    ECT MACHINE

    FDA Adverse Event
    Injury ·UNK·Product code GXC·December 28, 2016

    THYMATRON

    FDA Adverse Event
    Injury ·SOMATICS LLC·Product code GXC·January 8, 2010

    UNKNOWN

    FDA Adverse Event
    Injury ·UNKNOWN·Product code GXC·January 21, 2010

    MECTA NOW OWNED BY GORHAM AND ROBIN NICOL

    FDA Adverse Event
    Injury ·MECTA NOW OWNED BY GORHAM AND ROBIN NICOL·Product code GXC·January 2, 2010

    ECT

    FDA Adverse Event
    Injury ·Product code GXC·January 6, 2010

    ELECTROCONVULSIVE THERAPY

    FDA Adverse Event
    Injury ·Product code GXC·January 7, 2010

    ECT MACHINE

    FDA Adverse Event
    Malfunction ·MECTA CORP.·Product code GXC·July 19, 1996

    ELECTRIC SHOCK THERAPY

    FDA Adverse Event
    Injury ·UNKNOWN·Product code GXC·July 3, 1996

    ELECTROSHOCK

    FDA Adverse Event
    Injury ·UNK·Product code GXC·August 27, 1996

    CONCORD HOSPITAL

    FDA Adverse Event
    Other ·*·Product code GXC·January 28, 2004

    ECT TREATMENT

    FDA Adverse Event
    Injury ·UNK·Product code GXC·April 20, 2021

    ECT DEVICE

    FDA Adverse Event
    Injury ·Product code GXC·May 18, 2021

    ECT MACHINE

    FDA Adverse Event
    Injury ·UNK·Product code GXC·November 12, 2021