BEUDAMED
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    ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964072222·The ENDO CARRY-ON Procedure Kit contains all of...

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111017933·CATH TRAY 8 3/4"X3 1/4"X1 1/2"

    Sklar®

    FDA UDI
    SKLAR CORPORATION·30649111011331·CATH TRAY 83/4X31/4X11/2 PK-12

    Sklar®

    FDA UDI
    SKLAR CORPORATION·30649111078372·CATH TRAY 8.75X3.25X1.5 PK 6

    First Choice Partial Ulnar Head Implant

    FDA UDI
    Smith & Nephew, Inc.·00885556826560·FIRST CHOICE HEAD 19.0-STEM 5.5

    MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250

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

    GALAXY G3 XSFT 2MM X 2CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·January 25, 2021

    ACCELSTIM

    FDA Adverse Event
    Injury ·ORTHOFIX·Product code LOF·June 5, 2023

    BARD - PARKER

    FDA Adverse Event
    Malfunction ·ASPEN SURGICAL PRODUCTS, INC.·Product code GES·April 22, 2013

    NURSE CALL CABLE

    FDA Adverse Event
    Malfunction ·J. T. POSEY CO.·Product code KMI·September 15, 2014

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·May 18, 2011

    VASOPRESS DIGITAL MINI PUMP

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code JOW·January 6, 2020

    VASOPRESS DIGITAL MINI PUMP

    FDA Adverse Event
    Malfunction ·COMPRESSION THERAPY CONCEPTS, INC.·Product code JOW·February 18, 2020

    VASOPRESS DIGITAL MINI PUMP

    FDA Adverse Event
    Malfunction ·COMPRESSION THERAPY CONCEPTS, INC.·Product code JOW·September 17, 2019

    VASOPRESS DIGITAL MINI PUMP

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code JOW·November 19, 2019

    VASOPRESS DIGITAL MINI PUMP

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code JOW·November 19, 2019

    VASOPRESS DIGITAL MINI PUMP

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code JOW·December 10, 2019

    Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·November 27, 2013