BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    SpineFrontier Lumbar Interbody Fusion Device System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707011262·CALIBRA 1ST MOL BANDS W/G8025-02 n.UR 4

    Innomed, Inc.

    FDA UDI
    INNOMED, INC.·00840277101075·Cheng .187 Diameter Dilator Shaft

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172973684·

    FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NAIL HANDLE T2 TIBIA

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·October 6, 2014

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code KWB·June 3, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 28, 2011

    Telesheath Left Atrial Introducer System Right Superior. Telesheath Catheter Two-Piece Introducer Kit with Hemostasis Valve. Right Superior Reorder #407900. The product is packaged in an open, semi-rigid plastic tray, which is then placed in a sterile barrier pouch consisting of Tyvek on one side and a clear plastic film on the other. This pouch is then heat sealed prior to sterilization.

    FDA Recall
    Terminated ·St. Jude Medical/Daig Division·Product code DYB·August 4, 2004

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020