ClearanceBrief
Company

Maquet Medical Systems USA

FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.

0510(k) clearances (0 in 12 months)
41recalls (0 in 12 months)
37recalls that name a 510(k)

Product codes

CodeDeviceRecords
DTZOxygenator, Cardiopulmonary Bypass22
DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass10
FQOTable, Operating-Room, Ac-Powered2
KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type2
DTNReservoir, Blood, Cardiopulmonary Bypass1
DTRHeat-Exchanger, Cardiopulmonary Bypass1
DWCController, Temperature, Cardiopulmonary Bypass1
FSYLight, Surgical, Ceiling Mounted1
OUGMedical Device Data System1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Sep 30, 2024Maquet Medical Systems USA
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 pe
Open, Classified
DTQK133598
May 16, 2024Maquet Medical Systems USA
CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
Open, Classified
DTQK133598
Feb 13, 2024Maquet Medical Systems USA
BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.
Open, Classified
DTZK112360
Feb 13, 2024Maquet Medical Systems USA
Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.
Open, Classified
DTZK112360
Feb 8, 2024Maquet Medical Systems USA
Bubble Sensor (REF: 70105.5720)
Open, Classified
DTQK133598
Feb 2, 2024Maquet Medical Systems USA
BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
Open, Classified
KFMK090515
Feb 2, 2024Maquet Medical Systems USA
BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
Open, Classified
KFMK080470
Dec 21, 2023Maquet Medical Systems USA
Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
Open, Classified
DTQK133598
Dec 14, 2023Maquet Medical Systems USA
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
Open, Classified
DTQK133598
Dec 7, 2023Maquet Medical Systems USA
CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.
Open, Classified
DTQK133598
Nov 9, 2023Maquet Medical Systems USA
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
Open, Classified
DTQK133598
May 30, 2023Maquet Medical Systems USA
QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOL
Open, Classified
DTZK102726
May 30, 2023Maquet Medical Systems USA
Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA
Open, Classified
DTZK102919
May 30, 2023Maquet Medical Systems USA
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA 701070412 HMO 11000-USA 701
Open, Classified
DTZK102464
May 30, 2023Maquet Medical Systems USA
QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA 701067820 HMO 71000-USA 7010678
Open, Classified
DTZK082117
May 30, 2023Maquet Medical Systems USA
QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMOD30000-USA 701070397 BEQ-HMOD30000-USA 701050330
Open, Classified
DTZK100278
May 30, 2023Maquet Medical Systems USA
QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HMO 50000-USA 701067905 HMO 50000-USA 701067891 HMO 51000-USA
Open, Classified
DTZK090689
May 30, 2023Maquet Medical Systems USA
QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000-USA 701067840 BEQ-HMOD70000-USA 701067859
Open, Classified
DTZK101153
May 30, 2023Maquet Medical Systems USA
QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
Open, Classified
DTZK103191
May 26, 2023Maquet Medical Systems USA
QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE Coating BE
Open, Classified
DTQK102726
May 26, 2023Maquet Medical Systems USA
Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445
Open, Classified
DTNK102919
May 26, 2023Maquet Medical Systems USA
QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
Open, Classified
DTRK103191
May 26, 2023Maquet Medical Systems USA
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 10000-USA 701070412 HMO 11000-USA 701070416
Open, Classified
DTZK102464
May 26, 2023Maquet Medical Systems USA
BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829
Open, Classified
DTZK090511
May 26, 2023Maquet Medical Systems USA
QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 70000-USA 701067820 HMO 71000-USA 701067823
Open, Classified
DTZK082117
May 26, 2023Maquet Medical Systems USA
QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 50000-USA 701067891 HMO 51000-USA 701067895
Open, Classified
DTZK090689
May 26, 2023Maquet Medical Systems USA
BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. 701067905
Open, Classified
DTZK150267
May 26, 2023Maquet Medical Systems USA
BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859
Open, Classified
DTZK101153
May 26, 2023Maquet Medical Systems USA
HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067840
Open, Classified
DTZK101153
Feb 28, 2023Maquet Medical Systems USA
BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078. Part of the CARDIOHELP System, a pre-connected set used for extr
Open, Classified
DTZK112360
Jul 22, 2022Maquet Medical Systems USA
BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
Open, Classified
DTZK112360
Jul 22, 2022Maquet Medical Systems USA
BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
Open, Classified
DTZK112360
Jul 22, 2022Maquet Medical Systems USA
BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
Open, Classified
DTZK112360
Jul 22, 2022Maquet Medical Systems USA
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.
Open, Classified
DTZK112360
Feb 18, 2022Maquet Medical Systems USA
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 a
Open, Classified
DTQK133598
Jul 14, 2021Maquet Medical Systems USA
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 pa
Terminated
DWCK031544
Oct 5, 2016Maquet Medical Systems USA
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
Terminated
FQONone listed
Jan 16, 2015Maquet Medical Systems USA
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 m
Terminated
OUGNone listed
Jun 6, 2014Maquet Medical Systems USA
Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient.
Terminated
FSYNone listed
Oct 25, 2013Maquet Medical Systems USA
MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany. Cardiopulmonary support system.
Terminated
DTQK102726
Jul 30, 2012Maquet Medical Systems, Usa
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
Terminated
FQONone listed
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