BEUDAMED
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    DeGen Medical Patient Specific Implant (PSI) System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IMALUX OCT PROBE GUIDE

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

    DA VINCI FIREFLY IMAGING SYSTEM

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

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code MAF·November 20, 2008

    ACTIVA RC

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·August 17, 2011

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 22, 2013

    Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239

    FDA Enforcement
    Class I ·Ongoing·Bard Peripheral Vascular Inc·March 12, 2025

    Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) 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; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

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