BEUDAMED
    29 results · 23ms · Sources: EU EUDAMED, US FDA

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    FUTURA

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Oticon

    FDA UDI
    Oticon A/S·05707131189622·K210, ITC P PB R BE

    ELMED INCORPORATED

    FDA UDI
    ELMED INCORPORATED·00198506084744·DEBAKEY-SATINSKY TANGENTIAL OCCLUSION CLAMPS, 9...

    ALL SILICONE FOLEY BALLOON CATHETER

    FDA UDI
    Sewoon Medical Co., Ltd.·08806369400602·2way/Green 30cc 24fr

    Forefoot Screws

    FDA UDI
    Life Spine, Inc.·00190837019983·

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383502528·Gutta Percha Points is used to root canal filin...

    POLYTEL(R) APT MODEL: PWA-08-01

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    C2000 POWERED WHEELCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    DUAL COOLER/HEATER

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·May 2, 2013

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·August 27, 2014

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DRY·May 20, 2011

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·Product code FOZ·June 25, 2021

    ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FGE·April 25, 2019

    ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FGE·January 4, 2019

    ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FGE·February 18, 2019

    ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FGE·July 26, 2019

    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

    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