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

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

    Unity Total Knee System

    FDA UDI
    CORIN LTD·05056139244032·UNITY KNEE™ PS-C INSERT - Size 5 x 10mm

    ATLANTIS® Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994241061·SCREW 3120510 4.0 X 10 SELF DRILL VAR

    SMARTLOCK

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540491831·LOCKING SCREW, CROSS-PIN

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707009474·CALIBRA 1ST MOLAR BANDS n.UR 10

    5 x10mm CitreLock Xpress Implant Kit

    FDA UDI
    Acuitive Technologies, Inc.·00810027270306·

    SMOKE EVACUATION HOSES/TUBING

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

    CERAMIR CROWN & BRIDGE

    FDA 510(k)
    FDA Class 2 ·Dental

    LOCKING SCREWS, CROSS-PIN, DIAM 2.0X10MM, (5/PACKA

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS FREIBURG·Product code JEY·September 28, 2010

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·October 22, 2014

    LUBRI-SIL IC COMPLETE CARE FOLEY TRAY #16FR

    FDA Adverse Event
    Injury ·BARD·Product code EYC·May 20, 2013

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·September 26, 2014

    SIGMA SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Other ·SIGMA LLC·Product code FRN·June 8, 2011

    EGIA 45 ARTICULATING MED/THICK SULU

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·December 9, 2015

    KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway

    FDA Enforcement
    Class II ·Terminated·King Systems Corp.·November 28, 2012

    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