Company ยท DE
MAQUET Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2022. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
49recalls (1 in 12 months)
36recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 17 |
| FTD | Lamp, Surgical | 8 |
| FSY | Light, Surgical, Ceiling Mounted | 5 |
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 4 |
| DWE | Tubing, Pump, Cardiopulmonary Bypass | 3 |
| FLE | Sterilizer, Steam | 3 |
| FQO | Table, Operating-Room, Ac-Powered | 3 |
| FWZ | Operating Room Accessories Table Tray | 3 |
| BSZ | Gas-Machine, Anesthesia | 1 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | 1 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 |
| KXJ | Table, Radiologic | 1 |
| LFQ | Acid, Uric, Acid Reduction Of Ferric Ion | 1 |
| NCP | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 18, 2022 | K214120 | GSS610N21 Series Steam Sterilizer Maquet GmbH, DE | FLE |
| Mar 1, 2021 | K201927 | Getinge GSS610N Series Steam Sterilizer Maquet GmbH, DE | FLE |
| Jan 30, 2018 | K172159 | Getinge GSS67N Series Steam Sterilizer Maquet GmbH, DE | FLE |
| Mar 16, 2007 | K070442 | POWERLED SURGICAL LIGHT SYSTEM Maquet S.A. | FSY |
| Apr 26, 2004 | K030071 | SERVO GUARD, MODEL 64 81 290 EH88E Maquet, Inc. | CAH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2026 | Maquet SAS PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm)
Model Numbers: 1. ARD568474114A, 2. ARD567501286; Open, Classified |
FSY | K070442 |
| Aug 22, 2025 | MAQUET GMBH Corin Operating Tables
Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2;
All Software Versions. Open, Classified |
FQO | None listed |
| Jun 14, 2018 | Maquet SAS VOLISTA StandOP Surgical Light,
ARD568811961
VLT600DF AIM STP;
ARD568821961
VLT600DF AIM STP QL;
ARD568811911
VLT600SF AIM STP;
ARD568821911
VLT600SF AIM STP QL;
ARD568821910
VLT600SF STP QL;
ARD5688 Terminated |
FTD | K130513 |
| Apr 19, 2018 | Maquet SAS VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref. ARD568801560; Part numbers: 568811901, VLT600SF AIM STP; 568811911, VLT600SF AIM S Terminated |
FTD | K130513 |
| Dec 20, 2017 | Maquet Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 701066990.
Used in extracorporeal circulation during cardiopulmonary bypass procedures lasting 6 hours or less. Terminated |
DWE | K053025 |
| Jan 3, 2013 | Maquet Inc. Maquet Yuno Extension Table Device
Maquet GmbH & Co. KG
Kehler Strabe 31
Baden-Wuerttemberg
76437 Rastatt,Germany
Used to support the lower extremities immediately before during and after surgery. T Terminated |
FWZ | None listed |
| Aug 15, 2012 | Maquet Inc. Maquet Getinge Group Pediatric Arterial Cannula
Maquet Cardiopulmonary AG Kehler Strabe 31
76437 Rastatt Germany Phone +49 7222 932-0
Fax: +49 7222 932-1888
info.cp@maquet.com
www.maquet.com
Used to Terminated |
NCP | K023251 |
| Apr 3, 2012 | Maquet Inc. Servo-s ventilator system
Product Usage: Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency. Terminated |
CBK | K041223 |
| Apr 3, 2012 | Maquet Inc. Servo-i ventilator system
Product Usage: Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency. Terminated |
CBK | K041223 |
| Jan 11, 2012 | Maquet Inc. Magnus Hybrid operating table columns 1180.01A1 and 1180.01B1 Terminated |
LFQ | None listed |
| Dec 2, 2011 | Maquet Inc. Maquet PC Board PC1772 Spare Part
Device Part number 64 67 620
Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory in Terminated |
CBK | K041223 |
| Dec 2, 2011 | Maquet Inc. Maquet Servo-S ventilator system
Device Part number 66 40 440
Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory ins Terminated |
CBK | K041223 |
| Dec 2, 2011 | Maquet Inc. Maquet Servo-i ventilator system
Device Part number 64 87 800
Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory ins Terminated |
CBK | K041223 |
| Aug 29, 2011 | Maquet Inc. Maquet HL Console for Heart Lung Machine HL20
HL 20 4-pumps console base: P/N 917741
HL 20 5-pumps console base: P/N 917751
Intended for use as an extracorporeal circulation device for perfusion last Terminated |
DTQ | K943803 |
| Aug 22, 2011 | Maquet Inc. Maquet HL Console for Heart Lung Machine HL20:
HL 20 4-pumps console base: P/N 917741
HL 20 5-pumps console base: P/N 917751
The HL 20 is indicated for use as an extracorporeal circulation device for Terminated |
DTQ | K943803 |
| Jun 23, 2011 | Maquet Inc. Servo-s Ventilator Systems; Article number 66 40 440.
Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory insufficiency; these are only to Terminated |
CBK | None listed |
| Jun 23, 2011 | Maquet Inc. Servo-i Ventilator Systems; Article number 64 87 800
Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory insufficiency; these are only to Terminated |
CBK | None listed |
| May 23, 2011 | Maquet Inc. Maquet Magnus Carbon-fibre table top; Device Part Number 1180.16xx (x represents a digit from 0-5 and F-for the US market)
The carbon-fibre MAGNUS table top serves to support and position patients fo Terminated |
KXJ | None listed |
| Oct 6, 2010 | Maquet Inc. MAQUET HLM Tubing set with Bioline Coating (BEQ-TOP 21400 with 1/2 x 1/2 HG 0286 Connector; Device Part Number BEQ-TOP 21400 Terminated |
DWE | K080592 |
| Sep 12, 2010 | Maquet Inc. Maquet HLM Tubing Pack; Bioline Coating Terminated |
DWE | K053025 |
| Jan 5, 2010 | MAQUET Inc. Maquet Servo Ventilator SV900C/D/E (SV900)
Siemens-Elema AB, Solna, Sweden Terminated |
CBK | K871254 K884520 |
| Jan 5, 2010 | MAQUET Inc. Maquet Servo Ventilator 300/300A (SV300)
Siemens - Elema AB, Terminated |
CBK | K902859 K970839 |
| Dec 2, 2009 | Maquet Inc. Maquet Accessories, Connection Bracket. Catalogue # 1180.36A0.
An accessory component for the MAGNUS operating table system. Used to mount head positioning accessories. Terminated |
FWZ | None listed |
| Nov 12, 2009 | MAQUET Inc. XTEN LED DF cupola, P/N: 567815999.
Intended to provide visible illumination for the surgical field or for the examination of the patient. Terminated |
FSY | K040735 |
| Nov 12, 2009 | MAQUET Inc. XTEN LED Video DF cupola, P/N: 567801999.
Intended to provide visible illumination for the surgical field or for the examination of the patient. Terminated |
FSY | K040735 |
| Nov 12, 2009 | MAQUET Inc. XTEN DF cupola, P/N: 567800999.
Intended to provide visible illumination for the surgical field or for the examination of the patient. Terminated |
FSY | K040735 |
| Nov 12, 2009 | MAQUET Inc. HANAULUX 2004-2005 TV Spring Arm, P/N: 569002998.
Intended to provide visible illumination for the surgical field or for the examination of the patient. Terminated |
FTD | K895715 |
| Nov 12, 2009 | MAQUET Inc. HANAULUX 2005 IXL cupola, P/N: 56076869.
Intended to provide visible illumination for the surgical field or for the examination of the patient. Terminated |
FTD | K895715 |
| Nov 12, 2009 | MAQUET Inc. HANAULUX 2005 I cupola, P/N: 56076865.
Intended to provide visible illumination for the surgical field or for the examination of the patient. Terminated |
FTD | K895715 |
| Nov 12, 2009 | MAQUET Inc. HANAULUX 2004 IXL cupola, P/N: 56076868
Intended to provide visible illumination for the surgical field or for the examination of the patient. Terminated |
FTD | K895715 |
| May 12, 2009 | MAQUET Inc. Servo Ventilator 300 (Model SV300) and
Servo Ventilator 300 (Model SV300A).
The SV300 is intended for general and critical ventilatory care for use on adults, pediatric, infant and neonatal patients. Terminated |
CBK | K902859 K970839 |
| Apr 12, 2009 | MAQUET Inc. Alm Prismatic Surgical Light 5004 SF;
Maquet SA.
ALM PRISMATIC (PRC) Surgical Lights are used to provide visible illumination for the surgical field or for the examination of the patient. PRC is des Terminated |
FTD | K882613 |
| Apr 12, 2009 | MAQUET Inc. ALM Prismatic Surgical Light 9551 DF;
Maquet SA.
ALM PRISMATIC (PRC) Surgical Lights are used to provide visible illumination for the surgical field or for the examination of the patient. PRC is des Terminated |
FTD | K882613 |
| Feb 3, 2009 | MAQUET Inc. SERVO Ventilator 300A (SV300A);
Maquet Critical Care Ab, Solna, Sweden.
The device is intended for general and critical ventilatory care of adult, pediatric, infant and neonatal patients. The unit Terminated |
CBK | K970839 |
| Jan 15, 2009 | MAQUET Inc. Foot switch, Part Number 1009.81. Maquet GmbH & Co. KG, 76437 Rastatt, Germany.
The foot switches in the 1009.8 1 series are accessory components which can be connected to certain MAQUET operating t Terminated |
FWZ | None listed |
| Nov 5, 2008 | MAQUET Inc. Maquet Alphastar 1132.01AX/BX, 1132.02AX/BX, and 1132.03AX/BX Universal Operating Table Terminated |
FQO | None listed |
| Oct 16, 2008 | MAQUET Inc. Accessory Head Rest for Alphastar Operating Tables Terminated |
FQO | None listed |
| Sep 23, 2008 | MAQUET Inc. SERVO-s Ventilator System, Maquet Critical Care, Solna, Sweden. The product is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure Terminated |
CBK | K041223 |
| Sep 23, 2008 | MAQUET Inc. SERVO-i Ventilator System Maquet Critical Care, Solna, Sweden. The product is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure Terminated |
CBK | K041223 |
| Sep 7, 2007 | MAQUET Inc. Kion Anesthesia Workstation
Maquet Critical Care AB
SE-171-95 Solna, Sweden Terminated |
BSZ | None listed |
| Feb 10, 2007 | MAQUET Inc. Ventilator System Servo-i V3.1
Maquet Critical Care
PC1771 Terminated |
CBK | None listed |
| Jan 25, 2007 | MAQUET Inc. Ventilator System SERVO-i V3.1 PC1777
Maquet Critical Care Terminated |
CBK | K010925 |
| Jan 25, 2007 | MAQUET Inc. Jostra Heater Cooler Unit HCU30, system version 1.02-Low voltage machine Terminated |
DWC | K031544 |
| Nov 7, 2006 | MAQUET Inc. Jostra HL-20 Heart Lung Machine - guiding pins Terminated |
DTQ | K943803 |
| Nov 7, 2006 | MAQUET Inc. Jostra - HL-20 Heart Lung Integrated Perfusion System, Roller Pump Hand crank Terminated |
DTQ | K943803 |
| Aug 3, 2005 | Maquet Inc Polystan Coronary Cannula Balloon Tip. (Cardiopulmonary bypass vascular catheter). Terminated |
DWF | None listed |
| Jun 8, 2005 | Maquet Inc Servo-i Ventilator Terminated |
CBK | K040221 |
| Apr 14, 2005 | Maquet Inc KION Anesthesia System. Terminated |
BZR | K024213 |
| Mar 8, 2005 | Maquet Inc Servo-Ventilator, SV300/300A, Part numbers 6070391 and 6424704. The Safety Alert action targets customers with Unit Serial numbers 24578 and lower. Manuf. Maquet Critial Care AB, SE-171 95 Solna, S Terminated |
CBK | K902859 K970839 |