BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

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    SYMPHONY GRAFT DELIVERY SYSTEM (GDS)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Camber Spine Technologies Intermediary Fiber Optic Cable

    FDA UDI
    Lumitex, Inc.·00812432022983·

    CANNULATED PLUS SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BAYER RAPIDPOINT 400 SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MAGELLAN

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH, INC.·Product code FMI·September 6, 2023

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·March 20, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 2, 2011

    PATHFINDER

    FDA Adverse Event
    Malfunction ·ABBOTT SPINE·Product code HXX·March 12, 2008

    Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.

    FDA Enforcement
    Class II ·Ongoing·Preat Corp·June 25, 2025

    Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.

    FDA Recall
    Terminated ·Natus Medical Incorporated·Product code LBI·November 19, 2014

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022