ClearanceBrief
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

CodeDeviceRecords
CBKVentilator, Continuous, Facility Use17
FTDLamp, Surgical8
FSYLight, Surgical, Ceiling Mounted5
DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass4
DWETubing, Pump, Cardiopulmonary Bypass3
FLESterilizer, Steam3
FQOTable, Operating-Room, Ac-Powered3
FWZOperating Room Accessories Table Tray3
BSZGas-Machine, Anesthesia1
BZRMixer, Breathing Gases, Anesthesia Inhalation1
CAHFilter, Bacterial, Breathing-Circuit1
DWCController, Temperature, Cardiopulmonary Bypass1
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass1
KXJTable, Radiologic1
LFQAcid, Uric, Acid Reduction Of Ferric Ion1
NCP1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
May 18, 2022K214120GSS610N21 Series Steam Sterilizer
Maquet GmbH, DE
FLE
Mar 1, 2021K201927Getinge GSS610N Series Steam Sterilizer
Maquet GmbH, DE
FLE
Jan 30, 2018K172159Getinge GSS67N Series Steam Sterilizer
Maquet GmbH, DE
FLE
Mar 16, 2007K070442POWERLED SURGICAL LIGHT SYSTEM
Maquet S.A.
FSY
Apr 26, 2004K030071SERVO GUARD, MODEL 64 81 290 EH88E
Maquet, Inc.
CAH

Latest recalls

DateFirm and productCodeLinked 510(k)
Sep 18, 2026Maquet SAS
PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286;
Open, Classified
FSYK070442
Aug 22, 2025MAQUET GMBH
Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions.
Open, Classified
FQONone listed
Jun 14, 2018Maquet 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
FTDK130513
Apr 19, 2018Maquet 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
FTDK130513
Dec 20, 2017Maquet
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
DWEK053025
Jan 3, 2013Maquet 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
FWZNone listed
Aug 15, 2012Maquet 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
NCPK023251
Apr 3, 2012Maquet 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
CBKK041223
Apr 3, 2012Maquet 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
CBKK041223
Jan 11, 2012Maquet Inc.
Magnus Hybrid operating table columns 1180.01A1 and 1180.01B1
Terminated
LFQNone listed
Dec 2, 2011Maquet 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
CBKK041223
Dec 2, 2011Maquet 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
CBKK041223
Dec 2, 2011Maquet 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
CBKK041223
Aug 29, 2011Maquet 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
DTQK943803
Aug 22, 2011Maquet 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
DTQK943803
Jun 23, 2011Maquet 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
CBKNone listed
Jun 23, 2011Maquet 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
CBKNone listed
May 23, 2011Maquet 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
KXJNone listed
Oct 6, 2010Maquet 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
DWEK080592
Sep 12, 2010Maquet Inc.
Maquet HLM Tubing Pack; Bioline Coating
Terminated
DWEK053025
Jan 5, 2010MAQUET Inc.
Maquet Servo Ventilator SV900C/D/E (SV900) Siemens-Elema AB, Solna, Sweden
Terminated
CBKK871254
K884520
Jan 5, 2010MAQUET Inc.
Maquet Servo Ventilator 300/300A (SV300) Siemens - Elema AB,
Terminated
CBKK902859
K970839
Dec 2, 2009Maquet Inc.
Maquet Accessories, Connection Bracket. Catalogue # 1180.36A0. An accessory component for the MAGNUS operating table system. Used to mount head positioning accessories.
Terminated
FWZNone listed
Nov 12, 2009MAQUET 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
FSYK040735
Nov 12, 2009MAQUET 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
FSYK040735
Nov 12, 2009MAQUET Inc.
XTEN DF cupola, P/N: 567800999. Intended to provide visible illumination for the surgical field or for the examination of the patient.
Terminated
FSYK040735
Nov 12, 2009MAQUET 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
FTDK895715
Nov 12, 2009MAQUET 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
FTDK895715
Nov 12, 2009MAQUET 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
FTDK895715
Nov 12, 2009MAQUET 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
FTDK895715
May 12, 2009MAQUET 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
CBKK902859
K970839
Apr 12, 2009MAQUET 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
FTDK882613
Apr 12, 2009MAQUET 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
FTDK882613
Feb 3, 2009MAQUET 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
CBKK970839
Jan 15, 2009MAQUET 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
FWZNone listed
Nov 5, 2008MAQUET Inc.
Maquet Alphastar 1132.01AX/BX, 1132.02AX/BX, and 1132.03AX/BX Universal Operating Table
Terminated
FQONone listed
Oct 16, 2008MAQUET Inc.
Accessory Head Rest for Alphastar Operating Tables
Terminated
FQONone listed
Sep 23, 2008MAQUET 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
CBKK041223
Sep 23, 2008MAQUET 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
CBKK041223
Sep 7, 2007MAQUET Inc.
Kion Anesthesia Workstation Maquet Critical Care AB SE-171-95 Solna, Sweden
Terminated
BSZNone listed
Feb 10, 2007MAQUET Inc.
Ventilator System Servo-i V3.1 Maquet Critical Care PC1771
Terminated
CBKNone listed
Jan 25, 2007MAQUET Inc.
Ventilator System SERVO-i V3.1 PC1777 Maquet Critical Care
Terminated
CBKK010925
Jan 25, 2007MAQUET Inc.
Jostra Heater Cooler Unit HCU30, system version 1.02-Low voltage machine
Terminated
DWCK031544
Nov 7, 2006MAQUET Inc.
Jostra HL-20 Heart Lung Machine - guiding pins
Terminated
DTQK943803
Nov 7, 2006MAQUET Inc.
Jostra - HL-20 Heart Lung Integrated Perfusion System, Roller Pump Hand crank
Terminated
DTQK943803
Aug 3, 2005Maquet Inc
Polystan Coronary Cannula Balloon Tip. (Cardiopulmonary bypass vascular catheter).
Terminated
DWFNone listed
Jun 8, 2005Maquet Inc
Servo-i Ventilator
Terminated
CBKK040221
Apr 14, 2005Maquet Inc
KION Anesthesia System.
Terminated
BZRK024213
Mar 8, 2005Maquet 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
CBKK902859
K970839
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