BEUDAMED
    16 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: Open, Classified × Clear all

    DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP

    FDA Recall
    Open, Classified ·DeRoyal Industries Inc·Product code ITQ·November 21, 2019

    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0.it.1+TKA 1.0.1.it.1+PKA3.0.2.it. Application Part Number: 700002190743-01

    FDA Recall
    Open, Classified ·Stryker Orthopaedics·Product code OLO·April 15, 2024

    Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (French language), DCF-E110SG-IT/1 (Italian language)

    FDA Recall
    Open, Classified ·Defibtech, LLC·Product code MKJ·March 18, 2025

    CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product REF Numbers: 701072780; 701048012

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTQ·November 14, 2023

    CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass Part Number: 701072780, (CARDIOHELP-I US); 701048012 (CARDIOHELP-I NON US)

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTQ·November 6, 2023

    Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software

    FDA Recall
    Open, Classified ·LivaNova Deutschland GmbH Lindberghstr. 25 Munich Germany·Product code DTQ·October 18, 2024

    Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;

    FDA Recall
    Open, Classified ·Maquet Cardiopulmonary Gmbh Kehler Str. 31 Rastatt Germany·Product code DTQ·January 9, 2026

    Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.

    FDA Recall
    Open, Classified ·Maquet Cardiopulmonary Ag Kehler Str. 31 Rastatt Germany·Product code DTQ·April 30, 2025

    Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product Code/REF Number: 701072780 (Cardiohelp-i)

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTQ·February 18, 2022

    smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060JP; c) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070; d) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070JP; e) AIRWAY NASOPHARYNGEAL 8.0MM, REF 100/210/080; f) AIRWAY NASOPHARYNGEAL 8.0MM, REF 100/210/080JP; g) AIRWAY NASOPHARYNGEAL 8.0MM, REF 100/210/080JS; h) AIRWAY NASOPHARYNGEAL 9.0MM, REF 100/210/090; i) AIRWAY NASOPHARYNGEAL 9.0MM, REF 100/210/090JP;

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code BTQ·July 18, 2024

    Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTQ·October 12, 2023

    CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTQ·October 10, 2023

    CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTQ·April 15, 2024

    Bubble Sensor (REF: 70105.5720)

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTQ·December 28, 2023

    Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTQ·November 13, 2023

    QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE Coating BEQ-HMO 71100-USA 701067880 Adult with filter, with BIOLINE Coating HMO 50100-USA 701067934 Small Adult without filter, with SOFTLINE Coating HMO 51100-USA 701067938 Small Adult with filter, with SOFTLINE Coating HMO 70100-USA 701067874 Adult without filter, with SOFTLINE Coating HMO 71100-USA 701067886 Adult with filter, with SOFTLINE Coating

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTQ·May 18, 2023