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

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    LOSPA TOTAL KNEE REPLACEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FLEXIBLE TIP THERMOMETER, MODEL 011206

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AMISTEM H HA COATED STD STEM SIZE 2

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 17, 2021

    POWERPACK

    FDA Adverse Event
    Malfunction ·ICC-NEXERGY·Product code IYN·September 3, 2013

    HI-TORQUE WHISPER LS GUIDE WIRE

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code DQX·May 24, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 30, 2014

    PENTA 3MM LEAD, 60 CM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 14, 2011

    BD VACUTAINER® SERUM BLOOD COLLECTION TUBE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·September 18, 2019

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    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