BEUDAMED
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    DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074024813·BONE SCREW 7022740 20 DEG ILC 7.5X40 SS

    BD VENFLON PRO SAFETY SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·April 14, 2021

    TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CLEARFIL AP-X

    FDA 510(k)
    FDA Class 2 ·Dental

    EVOLUT FX DCS

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·February 24, 2025

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·March 27, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 17, 2011

    ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER - 45 MM STAPLE LINE 3.5 MM STAPLE LEG L

    FDA Adverse Event
    Death ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code GDW·March 25, 2008

    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

    Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided 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

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