BEUDAMED
    51 results · 19ms · 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 FDA Recall × Status: Open, Classified × Clear all

    X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.

    FDA Recall
    Open, Classified ·NuVasive Inc·Product code MQP·November 10, 2022

    AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, intermediate cartons containing 100 syringes, shipping cases containing 400 syringes, Rx, Sterile.

    FDA Recall
    Open, Classified ·MRP, LLC dba Aquabiliti·Product code NGT·December 28, 2023

    Navik 3D v2, REF NAVIK3D, 3D Mapping System

    FDA Recall
    Open, Classified ·APN Health LLC·Product code DQK·November 7, 2023

    IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code OAD·November 28, 2018

    IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code OAD·November 28, 2018

    Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code OAD·November 28, 2018

    Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions/sites.

    FDA Recall
    Open, Classified ·Philips Medical Systems Technologies Ltd. Matam Building 8/2 Advanced Technology Center Haifa Israel·Product code LLZ·October 10, 2024

    Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbers BD710DF282CRH BD710DF282RRH BD710FJ282CRH BD710FJ282RRH

    FDA Recall
    Open, Classified ·Product code NLH·July 31, 2025

    Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation.

    FDA Recall
    Open, Classified ·Abbott·Product code OAE·June 9, 2022

    THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in conjunction with an RF generator, for cardiac ablation.

    FDA Recall
    Open, Classified ·Johnson & Johnson Surgical Vision, Inc.·Product code OAD·September 7, 2022

    Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designed to be used for the creation of endocardial lesions (focal and linear) during cardiac ablation procedures for the treatment of symptomatic Atrial Fibrillation (AF). The PVAC GOLD is also intended to be used for cardiac electrophysiological (EP) mapping of pulmonary vein potentials, delivery of diagnostic pacing stimuli and verifying electrical isolation of the pulmonary veins post-treatment.

    FDA Recall
    Open, Classified ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code OAE·March 4, 2019

    Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·December 3, 2025

    Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·December 3, 2025

    Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·December 3, 2025

    Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·December 3, 2025

    Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·December 3, 2025

    SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·December 3, 2025

    Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·December 3, 2025

    SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·December 3, 2025

    Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·December 3, 2025