BEUDAMED
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    NON-STERILE & STERILE DISPOSABLE SURGICAL DRAPES

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

    NA

    FDA UDI
    Philips Medical Systems Hsg·00884838000018·HeartStart MRx monitor/defib

    LenSX Laser System

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER

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

    HEARTSTART MRX MONITOR/DEFIB

    FDA Adverse Event
    Malfunction ·PHILIPS NORTH AMERICA LLC·Product code MKJ·February 13, 2023

    HEARTSTART MRX MONITOR/DEFIB

    FDA Adverse Event
    Malfunction ·PHILIPS NORTH AMERICA LLC·Product code MKJ·October 27, 2022

    HEARTSTART MRX MONITOR/DEFIB

    FDA Adverse Event
    Malfunction ·PHILIPS NORTH AMERICA LLC·Product code MKJ·April 24, 2023

    ADVISA DR MRI SURESCAN

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·June 10, 2014

    SHUNT SENSOR SYS500

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·October 5, 2010

    LAMITRODE S8

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL NEUROMODULATION·Product code LGW·December 5, 2012

    HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·June 6, 2018

    AC power cords manufactured by Electri-Cord with tall bridge design. Used across all Philips product lines, as well as Respironics/Philips products, Dixtel owned products and Dixtal (formerly Novametrix or Respironics/Novametrix products. Philips HeartStart MRx Defibrillator/Monitor model number M3535A, ID number 861288. For use for the termination of ventricular tachycardia and ventricular fibrillation.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code MKJ·November 19, 2009

    HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code MKJ·May 3, 2018

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012