BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    MARINA MEDICAL SILICONE PESSARY

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    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

    VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156

    FDA 510(k)
    FDA Class 2 ·Dental

    Q-SYTE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FPA·January 3, 2026

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 2, 2013

    ACCU-CHEK FLEXLINK PLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FPA·March 18, 2011

    ANGLED MICRONOSE ATTACHMENTS

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBB·April 18, 2008

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020