BEUDAMED
    17 results · 42ms · Sources: EU EUDAMED, US FDA

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    SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 23, 2018

    6.5MM TI RECON SCREW WITH T25 STARDRIVE 105MM

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 23, 2018

    Leksell Stereotactic System

    FDA UDI
    Elekta Solutions AB·07340201502648·FIXATION SCREW 27,5 MM, TITANIUM

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257124628·15-20 MV FOR MEN CLSC CALF STD NAVY VI

    Myo/Wire II

    FDA UDI
    A & E MEDICAL CORPORATION·10841291101444·SS Suture, 5 per sleeve

    RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E

    FDA 510(k)
    FDA Class 2 ·Immunology

    ADVANTAGE WINDOWS CT/PET FUSION

    FDA 510(k)
    FDA Class 2 ·Radiology

    CADD

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FPA·March 23, 2022

    CADD MEDICATION CASSETTE

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FPA·July 14, 2022

    CADD

    FDA Adverse Event
    Malfunction ·NULL·Product code FPA·August 17, 2021

    CADD MEDICATION CASSETTES

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FPA·June 6, 2022

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·August 27, 2014

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE - 2

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC. (CININNATI)·Product code GDW·October 1, 2007

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·April 5, 2011

    Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 2019

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018