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

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    TRIATHLON POSTERIORLY STABILIZED (PS) FEMORAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707066897·ELASTIC CHAIN KIT TRANSPARENT

    CARTO XP SYSTEM

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, LTD·Product code DQK·November 30, 2007

    CARTO XP EP NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)·Product code DQK·August 14, 2008

    HERACERAM

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM

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

    CARTO XP EP NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER LTD. (HAIFA, ISREAL)·Product code DQK·April 17, 2008

    XMAX MOTOR

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code ERL·March 7, 2013

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 25, 2011

    EASYTRAK 2

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS·Product code DTB·May 8, 2008

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·December 19, 2023

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·August 3, 2022

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·February 16, 2023

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·April 25, 2023

    SUPER MULTIVAC 50 IFS

    FDA Adverse Event
    Malfunction ·ARTHROCARE CORP.·Product code GEI·March 17, 2020

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

    FDA Enforcement
    Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021