BEUDAMED
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    QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TSRH® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00673978042329·CROSSLINK 810-302 5.5MM LP L .750

    Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ADHESIVE EXL-759

    FDA 510(k)
    FDA Class 2 ·Dental

    CUP: MPACT ACETABULAR SHELL Ø54 NO-HOLE

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·December 13, 2023

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·April 10, 2014

    VOYAGER NC CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·October 31, 2012

    ACCU-CHEK ® MOBILE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 20, 2010

    LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging

    FDA Recall
    Terminated ·Product code REK·January 31, 2020

    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