BEUDAMED
    11 results · 26ms · Sources: EU EUDAMED, US FDA

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    PHADEBACT HAEMOPHILUS TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707062325·TUBE MIM 22/18/45 OCC L

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707056430·DB TUBE MIM 22/18/45 OCC LEFT

    LACTOSORB PUSH SCREW

    FDA 510(k)
    FDA Class 2 ·Dental

    NO!NO! SKIN

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 9, 2014

    MONARC SLING SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·October 19, 2012

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·May 26, 2015

    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Dako North America Inc.·November 11, 2015

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024