BEUDAMED
    56 results · 17ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Recall × Status: Open, Classified × Clear all

    MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)

    FDA Recall
    Open, Classified ·PATH Landsberger Str. 65 Germering Germany·Product code GWJ·November 6, 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

    Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160

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

    Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.

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