BEUDAMED
    94 results · 13ms · 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: Terminated × Clear all

    Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683

    FDA Recall
    Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JJY·May 22, 2018

    Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682

    FDA Recall
    Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JJY·May 22, 2018

    3M ESPE Rely X Veneer Cement Refill Syringes, A3 Opaque/Yellow Opaque Shade, manufactured by 3M. ESPE is a radiopaque , color stable light-cured resin cement indicated for bonding veneers fabricated of porcelainor composite.

    FDA Recall
    Terminated ·3M Espe Dental Products·Product code EBF·February 12, 2007

    Functional Anaesthetic Discography (F.A.D.) Catheter System, Catalog #: D01A, Kyphon, Inc., Sunnyvale, Ca 94089

    FDA Recall
    Terminated ·Kyphon Inc·Product code BSP·April 25, 2006

    8 FR 40CC Rediguard IAB, IAB-S840C, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.

    FDA Recall
    Terminated ·Arrow International, Inc.·Product code DSP·February 2, 2009

    8 Fr 30cc FIBEROPTIX IAB, IAB-05830-LWS, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.

    FDA Recall
    Terminated ·Arrow International, Inc.·Product code DSP·February 2, 2009

    Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 40cc. Model: IAB-05840-U

    FDA Recall
    Terminated ·Arrow International, Inc., Division of Teleflex Medical Inc.·Product code DSP·October 11, 2010

    Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 30cc. Model: IAB-05830-U

    FDA Recall
    Terminated ·Arrow International, Inc., Division of Teleflex Medical Inc.·Product code DSP·October 11, 2010

    Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)

    FDA Recall
    Terminated ·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·January 30, 2015

    Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX). Integra Long Epidural Steroid Injection Needle (Catalogue #PITRW2050). Peel Pouch. The Integra Long Epidural Steroid Injection Needle is packaged in a labeled and sterilized sealed tyvek / plastic pouch. The sterilized pouches are subsequently packaged in a case of 10 that is labeled, sealed and distributed to customers. Pain management procedure trays contain Tuohy Epidural Injection Needles to administer steroid medication in the epidural space. The needles are also available as an individually packaged single use, sterile device, as was the case with the affected lot in question.

    FDA Recall
    Terminated ·Integra LifeSciences Corp. d.b.a. Integra Pain Management·Product code BSP·May 1, 2015

    Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

    FDA Recall
    Terminated ·Arrow International, Inc., Division of Teleflex Medical Inc.·Product code DSP·February 10, 2016

    AutoCAT 2 Series Intra-Aortic Balloon Pumps Catalog No: IAP-0400, IAP-0435, IAP-0500, and IAP-0535, Arrow International, Everett, MA 02149

    FDA Recall
    Terminated ·Arrow International Inc·Product code DSP·November 12, 2007

    The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection. Laser Loupes have been assigned product code 79 FSP and are classified as a Class I Medical Devices. Laser Loupes are available with four (4) different filters of different colors. Each colored filter is associated with specific laser frequency ranges. The device listing number for this product is E160359. The intended use of this device is to magnify the operatory field and provide laser eye protection.

    FDA Recall
    Terminated ·Kerr Corporation·Product code FSP·April 10, 2012

    CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code DSP·March 27, 2012

    Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.

    FDA Recall
    Terminated ·Datascope Corporation·Product code DSP·February 21, 2018

    CS 100 Intra-Aortic Balloon Pump

    FDA Recall
    Terminated ·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·June 16, 2017

    smiths medical portex Loss of Resistance Device, REF 100/398/000

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code BSP·December 8, 2020

    Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and IMU7F-20 Software Version: Not applicable Product Description: The Insightra Ultra IABP Catheter Kit is a 7 French catheter available with either a 40, 35, 30, 25, or 20 cc balloon. The catheter has two lumens and is designed to provide counterpulsation cardiac assist therapy. The outer lumen is a channel for helium used to inflate and deflate the balloon. The inner lumen is used for a guidewire and blood pressure measurement. It is packaged as a convenience kit with accessories (one-way valve, 50 cc syringe, guide wires, introducer needle, dilator, pressure tubing, Datascope & Arrow adaptors). The balloon inflation and deflation cycle is synchronized (using a commercially available control console) with the ECG or arterial pressure to provide counterpulsation synchronized with the heartbeat. It is intended to increase coronary perfusion, decrease the workload of the left ventricle and allow healing of the myocardium Component: No

    FDA Recall
    Terminated ·Insightra Medical Inc·Product code DSP·July 19, 2025

    8 Fr 40cc Narrow Flex IAB Catheter Kit with Generic Adapters Product Number: IAB-04840-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.

    FDA Recall
    Terminated ·Arrow International, Inc.·Product code DSP·February 2, 2009

    8 Fr 30cc Ultra 8 IAB, IAB-05830-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.

    FDA Recall
    Terminated ·Arrow International, Inc.·Product code DSP·February 2, 2009