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

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    MODIFICATION TO THE I.C.O.S SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040012451·Zirlux 16+ B3 95X22

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526780736·LEVAMED ACTIVE ANKLE SUP SLVR L I

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517275875·CoRoent Large MP Trial, 8x9x28mm 8°

    ECHOSEED/IODINE-125 SEEDS, MODEL 6733

    FDA 510(k)
    FDA Class 2 ·Radiology

    LASER 20

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

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MDB·August 23, 2024

    XPS® BUR GUARD - VISAO®

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code ERL·April 22, 2016

    GMK-SPHERE PATELLA RESURFACING SIZE 3

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 26, 2021

    XPS® BUR

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code EQJ·March 13, 2017

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·March 19, 2013

    SUPER TURBOVAC 90 WITH INTEGRATED CABLE

    FDA Adverse Event
    Other ·ARTHROCARE CORP.·Product code GEI·February 24, 2011

    SOLUSET VENTED 100 X 60

    FDA Adverse Event
    Malfunction ·HOSPIRA DE COSTA RICA LTD.·Product code FPA·March 11, 2008

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·October 18, 2017