BEUDAMED
    18 results · 52ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    ZIMMON BILIARY STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·August 29, 2023

    ZIMMON PANCREATIC STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·August 29, 2023

    ZIMMON PANCREATIC STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·August 29, 2023

    (1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, REF 041210002A, 25/box, Sterile, Rx; (2) Argon Medical Devices Stopcocks, 1-Way w/Male Luer Lock, REF 041216000A, 25/box, Sterile, Rx; (3) Argon Medical Devices Stopcocks, Double 4-Way Stopcock w/Male Luer Lock, REF 041220001A, 25/box, Sterile, Rx; (4) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Rotating Male Luer Lock, REF 041240002A, Sterile, Rx; (5) Argon Medical Devices Stopcocks, North Carolina Baptist Hospital, Winston-Salem, NC, REF 042597300A, 25/box, Sterile, Rx; and (6) Argon Medical Devices 3 Way Stopcock w/Rotating Adapter (1050psi), REF 196590, 25/box, Sterile, Rx. The firm name on the labels is Argon Medical Devices, Inc., Athens, TX.

    FDA Enforcement
    Class II ·Terminated·Argon Medical Devices, Inc·November 13, 2019

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·January 24, 2019

    ZIMMON BILIARY STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·June 1, 2022

    ZIMMON BILIARY STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·May 31, 2022

    AXIOS STENT AND DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code PCU·September 28, 2016

    DAVINCI XI

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code NAY·March 6, 2025

    ZIMMON PANCREATIC STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 17, 2020

    GEENEN PANCREATIC STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·November 3, 2020

    TEXIUM CLOSED MALE LUER WITH FEMAILE CAP

    FDA Adverse Event
    Malfunction ·CAREFUSION NORTH CAROLINA·Product code FPA·July 6, 2020

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code FGE·September 14, 2018

    CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code KNS·October 25, 2022

    TRANSMITTER MMT-7841ZW GST5G OUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·July 20, 2022

    Prelude Short Sheath Introducer, Carolina Kidney and Endocrine - Declot tray, K12T-02693, Merit Medical Systems, Inc., South Jordan, Utah 84095. To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DYB·April 14, 2009

    (1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, REF 041210002A, 25/box, Sterile, Rx; (2) Argon Medical Devices Stopcocks, 1-Way w/Male Luer Lock, REF 041216000A, 25/box, Sterile, Rx; (3) Argon Medical Devices Stopcocks, Double 4-Way Stopcock w/Male Luer Lock, REF 041220001A, 25/box, Sterile, Rx; (4) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Rotating Male Luer Lock, REF 041240002A, Sterile, Rx; (5) Argon Medical Devices Stopcocks, North Carolina Baptist Hospital, Winston-Salem, NC, REF 042597300A, 25/box, Sterile, Rx; and (6) Argon Medical Devices 3 Way Stopcock w/Rotating Adapter (1050psi), REF 196590, 25/box, Sterile, Rx. The firm name on the labels is Argon Medical Devices, Inc., Athens, TX.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DRS·October 16, 2018

    One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.

    FDA Recall
    Terminated ·Lifescan Inc·Product code NBW·September 19, 2008