BEUDAMED
    72 results · 15ms · 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

    EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; b) DISS/NEMA 5-15 115V 60 HZ, Model Number M1230847; c) NIST/BS 1363 230V 50/60 HZ, Model Number M1230849; d) NIST/BS 546 230V 50/60 HZ, Model Number M1230849; e) NIST/CEE 7/7 230V 50/60 HZ, Model Number M1230849;

    FDA Recall
    Open, Classified ·Datex-Ohmeda, Inc.·Product code BTI·December 29, 2023

    PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device automatically compresses a resuscitator bag to provide air to the lungs of a COVID-19 patient, eliminating the human error and fatigue that results from manual actuation. PREVENT is indicated for emergency resuscitation with appropriate patient monitoring on adult patients that require mechanical respiratory support.

    FDA Recall
    Open, Classified ·Precision Valve & Automation, Inc·Product code BTL·June 26, 2020

    Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infused with natural medical-grade honey Manuka (Leptospermum) honey is a medical-grade honey that is harvested from bees in New Zealand. Researchers have found that this species has unique components that make it ideal for wounds.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp. (NeuroSciences)·Product code FRO·August 5, 2025

    Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code OAE·October 10, 2024

    Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code OAE·October 10, 2024

    TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter

    FDA Recall
    Open, Classified ·Abbott·Product code OAE·September 10, 2025

    Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code OAE·October 10, 2024

    EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT200L, SterileEO, Rx Only, UDI: 00812499030013

    FDA Recall
    Open, Classified ·EPIX THERAPEUTICS, INC·Product code OAE·February 22, 2021

    Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.

    FDA Recall
    Open, Classified ·Abbott·Product code OAE·March 24, 2022

    EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT100S,SterileEO, Rx Only, UDI: 00812499030006

    FDA Recall
    Open, Classified ·EPIX THERAPEUTICS, INC·Product code OAE·February 22, 2021

    EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB400L, SterileEO, UDI: 00812499030303

    FDA Recall
    Open, Classified ·EPIX THERAPEUTICS, INC·Product code OAE·February 22, 2021

    Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.

    FDA Recall
    Open, Classified ·Abbott·Product code OAE·March 24, 2022

    TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter

    FDA Recall
    Open, Classified ·Abbott·Product code OAE·September 10, 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

    Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, Material Number M004CRBS400Z0

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code OAE·October 10, 2024

    TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter

    FDA Recall
    Open, Classified ·Abbott·Product code OAE·September 10, 2025

    TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter

    FDA Recall
    Open, Classified ·Abbott·Product code OAE·September 10, 2025

    EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF CEDT100S, SterileEO, UDI 00812499030198

    FDA Recall
    Open, Classified ·EPIX THERAPEUTICS, INC·Product code OAE·February 22, 2021

    TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter

    FDA Recall
    Open, Classified ·Abbott·Product code OAE·September 10, 2025

    Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code OAE·October 10, 2024