BEUDAMED
    34 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4

    FDA Enforcement
    Class II ·Ongoing·Medtronic, Inc.·December 10, 2025

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·August 30, 2023

    EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·August 30, 2023

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    Smaxel Fractional CO2 Laser, a Class IV medical laser system.

    FDA Enforcement
    Class II ·Ongoing·IDS LTD·January 15, 2025

    Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA500Q Neutrino VR Implantable Cardioverter Defibrillator: NxT VR ICD REF CDVRA600Q Neutrino DR Implantable Cardioverter Defibrillator: NxT DR ICD REF CDDRA600Q Entrant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA300Q Entrant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA300Q The primary function of ICDs and CRT-Ds are to treat life-threatening ventricular tachyarrhythmias via anti-tachycardia pacing (ATP), or cardioversion/defibrillation. Implantable Cardioverter Defibrillators (ICDs) can either be a dual chamber (also known as DR if rate responsive) device that is connected to a right atrial (RA) pacing lead and right ventricular defibrillation lead or single chamber ICD (also known as VR if rate responsive) with only a defibrillation lead in the right ventricle (RV). The ICD, more generally known as an implantable pulse generator (IPG), is typically implanted in a subcutaneous device pocket located in the pectoral region and is attached to the pacing/defibrillator leads that are implanted through the transvenous technique with the distal tips positioned in the RA (dual chamber) and RV. Cardiac Resynchronization Therapy Defibrillator (CRT-D) systems consist of a right atrial (RA) pacing lead, a right ventricular (RV) defibrillation lead, as well as a third lead placed in the coronary venous system overlying the left ventricle (LV) to improve ventricular resynchronization through biventricular pacing for treatment of heart failure. CRT-D devices, more generally known as an implantable pulse generator (IPG), are typically implanted in a subcutaneous device pocket located in the pectoral region and are attached to the pacing/defibrillator leads that are implanted through transvenous technique.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·September 27, 2023

    DeRoyal PACEMAKER ICD PACK, REF 89-10902.01

    FDA Enforcement
    Class II ·Ongoing·DeRoyal Industries Inc·December 21, 2022

    DeRoyal PACEMAKER ICD PACK, REF 89-10216.06

    FDA Enforcement
    Class II ·Ongoing·DeRoyal Industries Inc·December 21, 2022

    DeRoyal PACEMAKER ICD PACK, REF 89-10216.03

    FDA Enforcement
    Class II ·Ongoing·DeRoyal Industries Inc·December 21, 2022

    EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·November 9, 2022

    EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·November 9, 2022

    Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·March 25, 2020

    Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·March 25, 2020

    Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·November 13, 2024

    Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constrained hip prosthesis

    FDA Enforcement
    Class II ·Ongoing·Zimmer, Inc.·November 12, 2025

    Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 110031013; semi constrained hip prosthesis

    FDA Enforcement
    Class II ·Ongoing·Zimmer, Inc.·November 12, 2025

    COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicated for airway management by oral/nasal intubation of the trachea for anesthesia or other short-term procedures.

    FDA Enforcement
    Class II ·Ongoing·Covidien·April 5, 2023