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

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    APOLONIA LASER IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16741026350·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1674102635060·

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383502931·Gutta Percha Points is used to root canal filin...

    REPROCESSED STRYKER ARTHROSCOPIC SHAVERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504

    FDA 510(k)
    FDA Class 2 ·General Hospital

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·August 31, 2018

    XMAX MOTOR

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code ERL·May 1, 2013

    CLEO 90 INFUSION SET

    FDA Adverse Event
    Injury ·SMITHS MEDICAL·Product code FPA·September 9, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·May 20, 2011

    RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM

    FDA Adverse Event
    Malfunction ·SYNTHES HAGENDORF·Product code LXH·October 20, 2016

    CANN CONNECTING SCR W/INTERNL THRD F/PERCUTAN INSERTN HANDLE

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code FZX·October 20, 2016

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·June 27, 2018

    SLEEK OTW PTA CATHETER

    FDA Adverse Event
    Injury ·CLEARSTREAM TECHNOLOGIES LTD.·Product code DQY·December 13, 2023

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

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

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

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

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

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