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

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    R2 Dermal Cooling System

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

    ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·June 11, 2013

    ACCU-CHEK AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 14, 2011

    MEDISENSE OPTIUM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 11, 2008

    LOGIC FEMORAL PS CEM LEFT SZ 5

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·December 15, 2023

    PUMP MMT-1880L MM770G BLE MG

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·January 16, 2023

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·December 12, 2022

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·February 4, 2025

    Jackson-Pratt Silicone Round Drain, 19FR. 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

    VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code 855 2630; IVD -- Ortho-Clinical Diagnostics, Pencoed, Bridgend CF35 5PZ, UK --- The VITROS Estradiol test is performed using the VITROS Estradiol Reagent Pack and Calibrators on VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Integrated Systems.

    FDA Enforcement
    Class II ·Terminated·ORTHO-CLINICAL DIAGNOSTICS·August 17, 2016