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

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    CHEMTROLER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ACUMED

    FDA UDI
    Acumed LLC·10806378097812·FFN 2.8mm Drill

    ACUMED

    FDA UDI
    Acumed LLC·10806378116902·FFN 2.8mm Drill

    JETCAN HUBER NEEEDLE SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AS3700 ANESTHSIA DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HEARTSTART FRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 21, 2014

    TEV GN BR 0 TC-43/HR 26 2N

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code GAW·October 18, 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