18 results · 54ms · 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

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

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

MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany. Cardiopulmonary support system.

FDA Recall
Terminated ·Maquet Medical Systems USA·Product code DTQ·September 12, 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 Recall
Terminated ·Maquet Medical Systems USA·Product code OUG·August 21, 2014

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

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

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 Enforcement
Class II ·Terminated·Maquet Medical Systems USA·August 4, 2021

HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.

FDA Recall
Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DTZ·November 20, 2020

HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.

FDA Recall
Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DTZ·November 20, 2020