BEUDAMED
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    REMOTE TECHNOLOGIES, INC.

    FDA registration
    REMOTE TECHNOLOGIES, INC.·1 product·🇺🇸 United States

    TECHSWITCH REMOTE EXPOSURE SWITCH

    FDA Adverse Event
    Malfunction ·REMOTE TECHNOLOGIES, INC.·Product code IZL·July 25, 2014

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·November 27, 2014

    NYLON SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAR·December 13, 2021

    OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DRF·October 4, 2023

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·November 27, 2014

    IN.PACT ADMIRAL

    FDA Adverse Event
    Injury ·INVATEC TECHNOLOGY CENTER GMBH·Product code ONU·March 6, 2015

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    FDA Adverse Event
    Injury ·INVATEC TECHNOLOGY CENTER GMBH·Product code ONU·March 6, 2015

    AUTOLITH TOUCH 1.9FR PROBE, 375CM DS BSC

    FDA Adverse Event
    Malfunction ·NORTHGATE TECHNOLOGIES, INC·Product code FFK·November 12, 2021

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    FDA Adverse Event
    Injury ·INVATEC TECHNOLOGY CENTER GMBH·Product code ONU·May 15, 2015

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    FDA Adverse Event
    Injury ·INVATEC TECHNOLOGY CENTER GMBH·Product code ONU·May 15, 2015

    Patient Cart used in conjunction with the da Vinci S surgical and SI System. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Patient Side Cart (PSC) is a robotic platform used for da Vinci Surgery. It is the operative component for both da Vinci systems and its primary function is to support he instrument arms and camera arm. It uses remote center technology. The remote center is a fixed point in space around which the Patient Cart arms move. Remote center technology enables the system to maneuver instruments and endoscopes in the surgical site while exerting minimal force on the patient body wall. The Patient Cart works in the sterile field, assisting the Surgeon Console operator by exchanging instruments and endoscopes, and by performing other patient-side activities. To help ensure patient safety, the action of the Patient Cart operator take precedence over actions of the Surgeon Console operator.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·November 30, 0012

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·November 27, 2014

    OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DRF·May 9, 2024

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·November 27, 2014

    WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DRF·May 19, 2022

    AUTOSTAINER LINK 48

    FDA Adverse Event
    Malfunction ·AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.·Product code KPA·June 1, 2023

    Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 24, 2013

    Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·February 12, 2013

    Philips Medical Systems Nederland B.V.

    Authorized representative
    🇳🇱 Netherlands·21 Manufacturers·1029 Devices