42 results
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61ms
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Sources: EU EUDAMED, US FDA
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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 Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·March 9, 2016
Bubble Sensor (REF: 70105.5720)
FDA Enforcement
Class II
·Ongoing·Maquet Medical Systems USA·February 14, 2024
BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
FDA Enforcement
Class II
·Ongoing·Maquet Medical Systems USA·February 14, 2024
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
FDA Enforcement
Class II
·Ongoing·Maquet Medical Systems USA·November 15, 2023
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 Enforcement
Class II
·Ongoing·Maquet Medical Systems USA·April 13, 2022
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 Enforcement
Class II
·Terminated·Maquet Medical Systems USA·November 16, 2016
BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
FDA Enforcement
Class II
·Ongoing·Maquet Medical Systems USA·February 14, 2024
CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.
FDA Enforcement
Class I
·Ongoing·Maquet Medical Systems USA·December 13, 2023
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 Enforcement
Class II
·Terminated·Maquet Medical Systems, Usa·August 8, 2012
Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient.
FDA Enforcement
Class II
·Terminated·Maquet Medical Systems USA·June 18, 2014
MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany. Cardiopulmonary support system.
FDA Enforcement
Class II
·Terminated·Maquet Medical Systems USA·November 6, 2013
TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration System is designed to be used as the central operating unit in an operating room. The integration system has two main functions: Recording and distribution of images and videos and interaction with medical and non-medical devices.
FDA Enforcement
Class II
·Terminated·Maquet Medical Systems USA·January 28, 2015
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA 701070412 HMO 11000-USA 701070416
FDA Enforcement
Class II
·Ongoing·Maquet Medical Systems USA·June 7, 2023
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 10000-USA 701070412 HMO 11000-USA 701070416
FDA Enforcement
Class II
·Ongoing·Maquet Medical Systems USA·June 7, 2023
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 Enforcement
Class II
·Ongoing·Maquet Medical Systems USA·June 7, 2023
QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMOD30000-USA 701070397 BEQ-HMOD30000-USA 701050330
FDA Enforcement
Class II
·Ongoing·Maquet Medical Systems USA·June 7, 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 Enforcement
Class II
·Ongoing·Maquet Medical Systems USA·June 7, 2023
BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829
FDA Enforcement
Class II
·Ongoing·Maquet Medical Systems USA·June 7, 2023
QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HMO 50000-USA 701067905 HMO 50000-USA 701067891 HMO 51000-USA 701067895
FDA Enforcement
Class II
·Ongoing·Maquet Medical Systems USA·June 7, 2023
QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
FDA Enforcement
Class II
·Ongoing·Maquet Medical Systems USA·June 7, 2023