BEUDAMED
    33 results · 26ms · Sources: EU EUDAMED, US FDA

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    Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112946·CORNEAL TREPHINE BLADE8.25MM

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112953·CORNEAL TREPHINE BLADE8.5MM

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112786·BARRON VACUUM PUNCH 8.25MM

    CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLES

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

    GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·February 18, 2005

    UNKNOWN ENDO GIA SULU

    FDA Adverse Event
    Injury ·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·April 2, 2021

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code LMG·May 25, 2022

    Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710200K Serial # >202169 and < 203249 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.

    FDA Enforcement
    Class I ·Terminated·B Braun Medical Inc·May 11, 2016

    SYNCHRON LX I725 CLINICAL SYSTEM

    FDA Adverse Event
    Injury ·BECKMAN COULTER, INC.·Product code MMI·August 5, 2011

    TENDRIL ST

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code NVN·January 13, 2014

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    FDA Adverse Event
    Malfunction ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FJI·June 28, 2013

    VALIANT NAVION

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·October 11, 2021

    CONTOUR 3D ANNULOPLASTY RING

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 6, 2021

    VALIANT STENT GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·April 7, 2021

    VALIANT CAPTIVIA UNK

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·April 7, 2021

    GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 2)

    FDA Adverse Event
    UNK·Product code MDS·September 29, 2021

    UNK - CONSTRUCTS: FNS

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HSB·November 4, 2022

    MEDTRONIC LEAD

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DXY·February 14, 2022