BEUDAMED
    49 results · 65ms · 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 ×

    TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).

    FDA Recall
    Terminated ·Laax, Inc.·Product code GDW·March 25, 2015

    TIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).

    FDA Recall
    Terminated ·Laax, Inc.·Product code GDW·March 25, 2015

    Accessory Adapter Part number 600525A0 Product Usage: designed for the mounting of MAQUET accessories with the dovetail guide interface immediately before, during and after surgical interventions as well as for examination and treatment.

    FDA Recall
    Terminated ·Maquet Medical Systems USA·Product code FQO·October 5, 2016

    Maquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH, Used to support the upper and lower extremities immediately before, during and after fracture surgery. The Extension Device (1180.19F0) is a table top module for use with the Maquet MAGNUS operating table system and it is attached to the base mounting point of the MAGNUS operating table.

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FQO·January 7, 2016

    Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version 1180.16 The carbon-fibre MAGNUS table top (1180-16XX) serves to support and position patients for surgical procedures (e.g. cardiovascular surgery) and interventional examination immediately before, during and after the surgical phase. The table top is radiotranslucent and enables intraoperative use of X-ray equipment.

    FDA Recall
    Terminated ·Maquet Medical Systems, Usa·Product code FQO·April 13, 2012

    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

    QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA 701070412 HMO 11000-USA 701070416

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

    QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMOD30000-USA 701070397 BEQ-HMOD30000-USA 701050330

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

    BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829

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

    Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled.

    FDA Recall
    Terminated ·Maquet Medical Systems USA·Product code DWC·July 14, 2021

    Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient.

    FDA Recall
    Terminated ·Maquet Medical Systems USA·Product code FSY·April 16, 2014

    QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA 701067820 HMO 71000-USA 701067823 BEQ-HMO 71000-USA 701067829

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

    Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445

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

    BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·July 22, 2022

    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 DTZ·May 18, 2023

    QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388

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

    QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 50000-USA 701067891 HMO 51000-USA 701067895

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

    Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445

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

    BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code KFM·January 8, 2024