BEUDAMED
    19 results · 21ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    Ez3D-i / E3

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPIRALE DRUG DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ENDOSCOPIC SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·March 1, 2023

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    CAPSURE SP

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·October 10, 2014

    FREESTYLE FREEDOM LITE

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 11, 2008

    UNIVERSA FIRM URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·June 25, 2019

    UNIVERSA FIRM URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·June 25, 2019

    UNIVERSA FIRM URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·June 26, 2019

    UNIVERSA FIRM URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·December 31, 2019

    UNIVERSA FIRM URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·December 31, 2019

    Jackson-Pratt Silicone Flat Drain, 10mm, 3/4 Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·May 31, 2017

    MEDISLIM

    FDA Adverse Event
    Injury ·MEDICREATIONS, LLC·Product code GEX·April 27, 2020

    UNIVERSA FIRM URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FAD·June 14, 2019

    UNIVERSA FIRM URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·June 26, 2019

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·July 23, 2019

    UNIVERSA FIRM URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·August 27, 2019

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018