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Maquet Medical Systems USA

34 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal syste recall (Z-0595-2024)Maquet Medical Systems USA2024-09-30
CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system. recall (Z-1831-2024)Maquet Medical Systems USA2024-05-16
Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Use recall (Z-1076-2024)Maquet Medical Systems USA2024-02-13
BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the recall (Z-1077-2024)Maquet Medical Systems USA2024-02-13
Bubble Sensor (REF: 70105.5720) recall (Z-1053-2024)Maquet Medical Systems USA2024-02-08
BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For recall (Z-0977-2024)Maquet Medical Systems USA2024-02-02
BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For recall (Z-0978-2024)Maquet Medical Systems USA2024-02-02
Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i Sys recall (Z-0605-2024)Maquet Medical Systems USA2023-12-21
CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal sys recall (Z-0555-2024)Maquet Medical Systems USA2023-12-14
CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is recall (Z-0420-2024)Maquet Medical Systems USA2023-12-07
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 recall (Z-0290-2024)Maquet Medical Systems USA2023-11-09
QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 3000 recall (Z-1655-2023)Maquet Medical Systems USA2023-05-30
QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000- recall (Z-1656-2023)Maquet Medical Systems USA2023-05-30
QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HM recall (Z-1657-2023)Maquet Medical Systems USA2023-05-30
QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMO recall (Z-1658-2023)Maquet Medical Systems USA2023-05-30
QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-US recall (Z-1659-2023)Maquet Medical Systems USA2023-05-30
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 1000 recall (Z-1660-2023)Maquet Medical Systems USA2023-05-30
Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. V recall (Z-1661-2023)Maquet Medical Systems USA2023-05-30
QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-US recall (Z-1662-2023)Maquet Medical Systems USA2023-05-30
HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 70 recall (Z-1634-2023)Maquet Medical Systems USA2023-05-26
BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 70106 recall (Z-1635-2023)Maquet Medical Systems USA2023-05-26
BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. recall (Z-1636-2023)Maquet Medical Systems USA2023-05-26
QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 50 recall (Z-1637-2023)Maquet Medical Systems USA2023-05-26
QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 70000-US recall (Z-1638-2023)Maquet Medical Systems USA2023-05-26
BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. recall (Z-1639-2023)Maquet Medical Systems USA2023-05-26
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 1000 recall (Z-1640-2023)Maquet Medical Systems USA2023-05-26
QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 3000 recall (Z-1641-2023)Maquet Medical Systems USA2023-05-26
Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. V recall (Z-1642-2023)Maquet Medical Systems USA2023-05-26
QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-US recall (Z-1643-2023)Maquet Medical Systems USA2023-05-26
BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set recall (Z-1188-2023)Maquet Medical Systems USA2023-02-28
TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration Syst recall (Z-0993-2015)Maquet Medical Systems USA2015-01-16
Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the pa recall (Z-1730-2014)Maquet Medical Systems USA2014-06-06
MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: recall (Z-0082-2014)Maquet Medical Systems USA2013-10-25
Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version 1180.16 recall (Z-2108-2012)Maquet Medical Systems, Usa2012-07-30

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Every clearance here is in the API, with alerts when new ones post.