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

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    MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573

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

    2008T HEMODIALYSIS SYS., WITH CDX

    FDA Adverse Event
    Malfunction ·CONCORD MANUFACTURING·Product code KDI·June 26, 2018

    MULTITRACK ANGIOGRAPHIC CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRILOGY 200

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC·Product code CBK·August 19, 2020

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·December 9, 2018

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DYE·March 25, 2020

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·May 4, 2020

    AVALUS AORTIC TISSUE VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·June 23, 2020

    SINGLE USE ELECTROSURGICAL KNIFE

    FDA Adverse Event
    Injury ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·April 25, 2013

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    JUMAO HEALTHCARE EQUIPMENT·Product code IOR·September 16, 2014

    HEARTSTRING PROXIMAL SEAL, 4.5 MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC.·Product code DXC·April 19, 2011

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·October 26, 2021

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 19, 2022

    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018