BEUDAMED
    225 results · 14ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii × Status: Ongoing × Clear all

    CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·January 29, 2025

    CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·January 29, 2025

    CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·January 29, 2025

    Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA) when the Triathlon Knee System is selected for use. Catalog Number: 5521-B-200

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    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

    FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascular use.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·February 10, 2021

    HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 13, 2023

    CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Product Usage: The CMI device, Ivy Sports Medicine s collagen-based meniscus implant, is comprised primarily of bovine type I collagen (nominally 99%) derived from tendon and small quantities of glycosaminoglycans (GAGs: chondroitin sulfate and sodium hyaluronate). The device functions as a resorbable scaffold that is replaced by the patient s own tissue.The CMI device is designed to function as an absorbable template to facilitate host meniscus tissue regeneration in patients who have an irreparable meniscus tear or loss of meniscus tissue. The CMI meniscus tissue through the implant s absorption and replacement by patient s native tissue.

    FDA Enforcement
    Class II ·Ongoing·Stryker Corporation·March 21, 2018

    CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·May 12, 2021

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025

    HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 13, 2023

    HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 13, 2023

    HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·May 25, 2022

    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

    PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 13, 2023

    PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 13, 2023

    PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 13, 2023

    OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite

    FDA Enforcement
    Class II ·Ongoing·IMPULSE DYNAMICS (USA) INC·February 28, 2024

    PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 13, 2023