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
| Code | Device | Records |
|---|---|---|
| DTZ | Oxygenator, Cardiopulmonary Bypass | 22 |
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 10 |
| FQO | Table, Operating-Room, Ac-Powered | 2 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 2 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 1 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 1 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | 1 |
| FSY | Light, Surgical, Ceiling Mounted | 1 |
| OUG | Medical Device Data System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2024 | Maquet 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 |
DTQ | K133598 |
| May 16, 2024 | Maquet Medical Systems USA CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system. Open, Classified |
DTQ | K133598 |
| Feb 13, 2024 | Maquet 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 |
DTZ | K112360 |
| Feb 13, 2024 | Maquet 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 |
DTZ | K112360 |
| Feb 8, 2024 | Maquet Medical Systems USA Bubble Sensor (REF: 70105.5720) Open, Classified |
DTQ | K133598 |
| Feb 2, 2024 | Maquet 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 |
KFM | K090515 |
| Feb 2, 2024 | Maquet 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 |
KFM | K080470 |
| Dec 21, 2023 | Maquet Medical Systems USA Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802 Open, Classified |
DTQ | K133598 |
| Dec 14, 2023 | Maquet 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 |
DTQ | K133598 |
| Dec 7, 2023 | Maquet 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 |
DTQ | K133598 |
| Nov 9, 2023 | Maquet Medical Systems USA Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder) Open, Classified |
DTQ | K133598 |
| May 30, 2023 | Maquet 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 |
DTZ | K102726 |
| May 30, 2023 | Maquet Medical Systems USA Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass
Model Item No.
VKMO 10000-USA 701070441
VKMO 11000-USA Open, Classified |
DTZ | K102919 |
| May 30, 2023 | Maquet Medical Systems USA QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass
Model Item No.
HMO 10000-USA 701070412
HMO 11000-USA 701 Open, Classified |
DTZ | K102464 |
| May 30, 2023 | Maquet Medical Systems USA QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass
Model Item No.
HMO 70000-USA 701067820
HMO 71000-USA 7010678 Open, Classified |
DTZ | K082117 |
| May 30, 2023 | Maquet Medical Systems USA QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass
Model Item No.
BEQ-HMOD30000-USA 701070397
BEQ-HMOD30000-USA 701050330 Open, Classified |
DTZ | K100278 |
| May 30, 2023 | Maquet 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 |
DTZ | K090689 |
| May 30, 2023 | Maquet Medical Systems USA QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass
Model Item No.
HMOD 70000-USA 701067840
BEQ-HMOD70000-USA 701067859 Open, Classified |
DTZ | K101153 |
| May 30, 2023 | Maquet Medical Systems USA QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass
Model Item No.
HMO 30000-USA 701070384
HMO 31000-USA 701070388 Open, Classified |
DTZ | K103191 |
| May 26, 2023 | Maquet 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 |
DTQ | K102726 |
| May 26, 2023 | Maquet Medical Systems USA Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass
Model Item No.
VKMO 10000-USA 701070441
VKMO 11000-USA 701070445 Open, Classified |
DTN | K102919 |
| May 26, 2023 | Maquet Medical Systems USA QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass
Model Item No.
HMO 30000-USA 701070384
HMO 31000-USA 701070388 Open, Classified |
DTR | K103191 |
| May 26, 2023 | Maquet Medical Systems USA QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass
Model Item no.
HMO 10000-USA 701070412
HMO 11000-USA 701070416 Open, Classified |
DTZ | K102464 |
| May 26, 2023 | Maquet Medical Systems USA BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass
Item no. 701067829 Open, Classified |
DTZ | K090511 |
| May 26, 2023 | Maquet Medical Systems USA QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass
Model Item no.
HMO 70000-USA 701067820
HMO 71000-USA 701067823 Open, Classified |
DTZ | K082117 |
| May 26, 2023 | Maquet 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 |
DTZ | K090689 |
| May 26, 2023 | Maquet Medical Systems USA BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass
Item no. 701067905 Open, Classified |
DTZ | K150267 |
| May 26, 2023 | Maquet Medical Systems USA BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass
Item no. 701067859 Open, Classified |
DTZ | K101153 |
| May 26, 2023 | Maquet Medical Systems USA HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass
Item no. 701067840 Open, Classified |
DTZ | K101153 |
| Feb 28, 2023 | Maquet 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 |
DTZ | K112360 |
| Jul 22, 2022 | Maquet 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 |
DTZ | K112360 |
| Jul 22, 2022 | Maquet 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 |
DTZ | K112360 |
| Jul 22, 2022 | Maquet 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 |
DTZ | K112360 |
| Jul 22, 2022 | Maquet 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 |
DTZ | K112360 |
| Feb 18, 2022 | Maquet 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 |
DTQ | K133598 |
| Jul 14, 2021 | Maquet 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 |
DWC | K031544 |
| Oct 5, 2016 | Maquet 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 |
FQO | None listed |
| Jan 16, 2015 | Maquet 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 |
OUG | None listed |
| Jun 6, 2014 | Maquet Medical Systems USA Maquet PowerLED 700.
Product Usage; To provide illumination to the surgical area or the patient. Terminated |
FSY | None listed |
| Oct 25, 2013 | Maquet 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 |
DTQ | K102726 |
| Jul 30, 2012 | Maquet 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 |
FQO | None listed |