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

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    Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111040245·PEET FCP ANG DBLE CVD 4 3/4"

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·July 21, 2025

    BRACCO INJEENERING TRANSFER SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MJA·April 10, 2025

    VSP SYSTEM

    FDA Adverse Event
    Injury ·3D SYSTEMS·Product code DZJ·December 18, 2020

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·October 7, 2008

    STELLARIS 25GA COMB VITRECTOMY PK W WF

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB, INC.·Product code HQC·June 25, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 5, 2011

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MJA·May 21, 2025

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·July 21, 2025

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·July 21, 2025

    AQUAPAK 340 SW, 340ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·February 18, 2015

    Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·June 19, 2013

    Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·April 27, 2016