BEUDAMED
    17 results · 22ms · Sources: EU EUDAMED, US FDA

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    RANDOX TRI LEVEL CARDIAC CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    JILCO TRACTION-FLEXION CHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ACCU-CHEK ® MOBILE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 8, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 23, 2011

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code LFR·May 15, 2008

    ACL ADVANCE

    FDA Adverse Event
    INSTRUMENTATION LABORATORY CO.·Product code JPA·July 13, 2005

    TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE CD 11 MM THICKNESS

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code MBH·August 3, 2018

    TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE CD 11 MM THICKNESS

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code MBH·August 3, 2018

    TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE CD 11 MM THICKNESS

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code MBH·August 3, 2018

    TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE CD 11 MM THICKNESS

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code MBH·August 3, 2018

    TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE CD 11 MM THICKNESS

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code MBH·August 3, 2018

    TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE CD 14 MM THICKNESS

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code MBH·August 2, 2018

    Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 2019

    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

    Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018