BEUDAMED
    17 results · 22ms · Sources: EU EUDAMED, US FDA

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    INFX-8000V, V5.30

    FDA 510(k)
    FDA Class 2 ·Radiology

    XCELA

    FDA Adverse Event
    Injury ·PFM MEDICAL CPP SA·Product code LJT·October 24, 2024

    K133532

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·February 2, 2021

    Freedom Pedicle Screw System

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215027650·

    Hermann Medizintechnik GmbH

    FDA UDI
    Hermann Medizintechnik GmbH·04059453002105·METZENBAUM scissors, left curved, Ø10mm, WL 330...

    Hermann Medizintechnik GmbH

    FDA UDI
    Hermann Medizintechnik GmbH·04059453004468·METZENBAUM scissors, left curved, Ø10mm, WL 330...

    Hermann Medizintechnik GmbH

    FDA UDI
    Hermann Medizintechnik GmbH·04059453028891·METZENBAUM scissors, left curved, Ø10mm, WL 330...

    Hermann Medizintechnik GmbH

    FDA UDI
    Hermann Medizintechnik GmbH·04059453024947·Insert, Metzenbaum scissors, left curvedØ10mm, ...

    LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VACPLUS SUCTION UNIT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 29, 2025

    TRI-LOCK TI 7.5 LAT OFFSET

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·October 1, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 29, 2013

    NEXGEN MIS STEMMED TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER INC.·Product code JWH·June 15, 2011

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    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