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

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    MAXMIXING BLOCK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    2700 NRBV

    FDA UDI
    HANS RUDOLPH, INC.·00817136026176·2700 2W NRBV W/MPORT SMC FMTR

    NEO / Kinetic Anterior Cervical Plate System

    FDA UDI
    Life Spine, Inc.·00190837036515·ACPS Double Barrel Fixed Drill Guide

    CYBERCASES BY BAUSCH & LOMB

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CASPIAN SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 8, 2013

    DELTA CER HEAD 12/14 32MM +1

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWZ·September 24, 2014

    PEG SMOOTH 2.0X20MM (3 EACH)

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LXT·May 20, 2011

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014

    ENDURANT II STENT GRAFT

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code MIH·July 8, 2022

    ENDURANT II STENT GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·July 8, 2022

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021