BEUDAMED
    17 results · 19ms · Sources: EU EUDAMED, US FDA

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    BLOOD TUBING SETS (STERILE FLUID PATH)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    AMARA

    FDA UDI
    Respironics, Inc.·00606959025127·AMARA MASK SE WITH RS FRAME AND HEADGEAR, MEDIU...

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036084752·

    COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CAVITY VARNISH

    FDA 510(k)
    FDA Class 2 ·Dental

    LANX SPINOUS PROCESS FUSION PLATE

    FDA Adverse Event
    Injury ·LANX, INC.·Product code KWP·March 17, 2011

    PROGRASP FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 3, 2013

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·May 2, 2013

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·September 15, 2014

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MAF·May 16, 2011

    Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·October 24, 2018

    Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources. Includes the following Model Numbers: 1. Model Number: 2090255-001; 2. Model Number: 2088026-723; 3. Model Number: 2102676-001; 4. Model Number: 2104867-044.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LLZ·August 6, 2021

    Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LLZ·May 17, 2019

    Centricity Universal Viewer Product Usage: The Centricity Universal Viewer Version 6.0 software is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification. Used in Radiology.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·September 2, 2015

    Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification. Used in Radiology.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·September 2, 2015

    Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources. Includes the following Model Numbers: 1. Model Number: 2090255-001; 2. Model Number: 2088026-723; 3. Model Number: 2102676-001; 4. Model Number: 2104867-044.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·September 29, 2021

    Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·July 3, 2019