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    Applied Tissue Technologies PWD™ Platform Wound Dressing

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

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528128909·2.4mm x 9mm Cannulated Lag Screw

    ZOLL IVTM THERMOGARD XP

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION·Product code NCX·September 20, 2023

    SOLAR LASER ABLATION SYSTEM, MODELS: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000, LG-2001, LK-001, PM-1083, TF-1083

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

    DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 14, 2025

    MIDWEST LOW SPEED ATTACHMENTS - CONTRA ANGLE SHEATH

    FDA Adverse Event
    Malfunction ·SIRONA DENTAL SYSTEMS GMBH·Product code EFB·April 20, 2023

    O3 PEDIATRIC SENSOR

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MUD·August 20, 2022

    O3 PEDIATRIC SENSOR

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MUD·August 19, 2022

    PROTECTA XT DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 21, 2013

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·July 11, 2011

    ACRYSOF TORIC

    FDA Adverse Event
    Other ·ALCON RESEARCH, LTD./HUNTINGTON·Product code MJP·September 12, 2008

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014