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

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    True Function Adjustable Herbst Appliances

    FDA 510(k)
    FDA Class 2 ·Dental

    ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CLINICAL THERMOMETER/MODEL ZSDT-XXXX DIGITAL THERMOMETER AND ZSET-XXX INFRARED THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 17, 2024

    VASERLIPO SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code QPB·January 9, 2023

    CENTURY STERILIZER

    FDA Adverse Event
    STERIS MEXICO, S. DE R.L. DE C.V.·Product code FLE·June 14, 2013

    ACCU-CHEK ® PERFORMA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 21, 2011

    STOCKERT HEATER-COOLER SYSTEM 3T

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DWC·September 26, 2014

    6.5 HEALIX BR ANCHOR W/OCORD

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code MAI·May 8, 2018

    6.5 HEALIX BR ANCHOR W/OCORD

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code MAI·May 8, 2018

    1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Telephone # +1 201-831-5000 Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France Intended for cementless application in total or hemiarthroplasty procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·December 18, 2013

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024