BEUDAMED
    12 results · 27ms · Sources: EU EUDAMED, US FDA

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    VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    RANDOX CARBAMAZEPINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    INTRASTENT DOUBLESTRUT PARAMOUNT

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

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·April 2, 2013

    ADVANTA BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·February 24, 2011

    RU PACING LEAD

    FDA Adverse Event
    Malfunction ·OSCOR INC.·Product code DTB·April 15, 2008

    Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·October 22, 2014

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    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