Maquet Cardiopulmonary G M B H

FDA Filings

This page includes the latest FDA filings for Maquet Cardiopulmonary G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number8010762
FEI Number3009649876
NameMAQUET CARDIOPULMONARY GmbH
Owner & OperatorMAQUET Cardiopulmonary GmbH
Contact AddressNEUE ROTTENBURGER STRASSE 37
HECHINGEN DE-BW Baden-Wurttemberg 72379 DE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressNeue Rottenburger Strasse 37
Hechingen Baden-Wurttemberg, 72379 DE
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198



Registration Number3014766792
FEI Number3014766792
NameMaquet Cardiopulmonary GmbH
Owner & OperatorGetinge AB
Contact AddressLindholmspiren 7
Gothenburg SE-O Vastra Gotalands lan [SE-14] SE-417 56 SE
Official Correspondent
  • Dennis Genito
  • 46-10-3359015-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressGrabenstr. 25
Bodelshausen Baden-Wurttemberg, 72411 DE
Establishment TypeComplaint File Establishment per 21 CFR 820.198



Registration Number3009507273
FEI Number3009507273
NameMAQUET CARDIOPULMONARY GmbH
Owner & OperatorMAQUET Cardiopulmonary GmbH
Contact AddressNEUE ROTTENBURGER STRASSE 37
HECHINGEN DE-BW Baden-Wurttemberg 72379 DE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressKehler Strasse 31
Rastatt Baden-Wurttemberg, 76437 DE
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
Maquet Cardiopulmonary GmbH [Getinge AB]
Maquet Cardiopulmonary Accessory2018-09-06
MAQUET CARDIOPULMONARY GmbH
Connectors2016-10-28
MAQUET CARDIOPULMONARY GmbH
Connectors2016-10-28
MAQUET CARDIOPULMONARY GmbH
Connectors with Softline2016-10-28
MAQUET CARDIOPULMONARY GmbH
Connectors with Softline2016-10-28
MAQUET CARDIOPULMONARY GmbH
Connectors with Bioline2016-10-28
MAQUET CARDIOPULMONARY GmbH
Connectors with Bioline2016-10-28
MAQUET CARDIOPULMONARY GmbH
Plegiox Cardioplegia Heat Exchanger2015-11-10
MAQUET CARDIOPULMONARY GmbH
Plegiox Cardioplegia Heat Exchanger with SOFTLINE Coating2015-11-10
MAQUET CARDIOPULMONARY GmbH
HLS-Set Advanced 7.0 and 5.0 (with BIOLINE Coating)2015-11-10
MAQUET CARDIOPULMONARY GmbH
HIT-Set Advanced 7.0 and 5.0 (SOFTLINE Coating)2015-11-10
MAQUET CARDIOPULMONARY GmbH
Plegiox Cardioplegia Heat Exchanger2015-11-10
MAQUET CARDIOPULMONARY GmbH
Plegiox Cardioplegia Heat Exchanger with SOFTLINE Coating2015-11-10
MAQUET CARDIOPULMONARY GmbH
HLS-Set Advanced 7.0 and 5.0 (with BIOLINE Coating)2015-11-10
MAQUET CARDIOPULMONARY GmbH
HIT-Set Advanced 7.0 and 5.0 (SOFTLINE Coating)2015-11-10
MAQUET CARDIOPULMONARY GmbH
Plegiox Cardioplegia Heat Exchanger2015-11-10
MAQUET CARDIOPULMONARY GmbH
Plegiox Cardioplegia Heat Exchanger with SOFTLINE Coating2015-11-10
MAQUET CARDIOPULMONARY GmbH
HLS-Set Advanced 7.0 and 5.0 (with BIOLINE Coating)2015-11-10
MAQUET CARDIOPULMONARY GmbH
HIT-Set Advanced 7.0 and 5.0 (SOFTLINE Coating)2015-11-10
MAQUET CARDIOPULMONARY GmbH
Plegiox Cardioplegia Heat Exchanger2015-11-10
MAQUET CARDIOPULMONARY GmbH
Plegiox Cardioplegia Heat Exchanger with SOFTLINE Coating2015-11-10
MAQUET CARDIOPULMONARY GmbH
HLS-Set Advanced 7.0 and 5.0 (with BIOLINE Coating)2015-11-10
MAQUET CARDIOPULMONARY GmbH
HIT-Set Advanced 7.0 and 5.0 (SOFTLINE Coating)2015-11-10
MAQUET CARDIOPULMONARY GmbH
Pediatric Arterial Cannulae2015-11-10
MAQUET CARDIOPULMONARY GmbH
QUADROX-iD Adult w and w/o Bioline2015-08-25
MAQUET CARDIOPULMONARY GmbH
QUADROX-i Small Adult with integrated Filter w and w/o Bioline2015-08-25
MAQUET CARDIOPULMONARY GmbH
QUADROX-i Small Adult w and w/o Bioline2015-08-25
MAQUET CARDIOPULMONARY GmbH
QUADROX-i Adult with integrated Filter w and w/o Bioline2015-08-25
MAQUET CARDIOPULMONARY GmbH
QUADROX-i Adult w and w/o Bioline2015-08-25
MAQUET CARDIOPULMONARY GmbH
Antegrade Cardioplegia Cannulae (N-type)2014-11-26
MAQUET CARDIOPULMONARY GmbH
CARDIOHELP-i and multiple accessories2014-07-28
MAQUET CARDIOPULMONARY GmbH
CARDIOHELP-i and multiple accessories2014-07-28
MAQUET CARDIOPULMONARY GmbH
uncoated and SOFTLINE coated2014-07-21
MAQUET CARDIOPULMONARY GmbH
Neonatal, Pediatric Venous Hardshell Cardiotomy Reservoir2014-07-21
MAQUET CARDIOPULMONARY GmbH
uncoated and SOFTLINE coated2014-07-21
MAQUET CARDIOPULMONARY GmbH
Neonatal, Pediatric Venous Hardshell Cardiotomy Reservoir2014-07-21
MAQUET CARDIOPULMONARY GmbH
QUADROX-iR Adult and Small Adult Oxygenators with Holding Clamp2014-01-15
MAQUET CARDIOPULMONARY GmbH
QUADROX-iR Adult and Small Adult Oxygenators with Holding Clamp2014-01-15
MAQUET CARDIOPULMONARY GmbH
QUADROX-iR Adult and Small Adult Oxygenators with Holding Clamp2014-01-15
MAQUET CARDIOPULMONARY GmbH
QUADROX-iR Adult and Small Adult Oxygenators with Holding Clamp2014-01-15
MAQUET CARDIOPULMONARY GmbH
QUADROX-iD Diffusion Membrane Oxygenators with Holding Clamp.2014-01-15
MAQUET CARDIOPULMONARY GmbH
QUADROX-i Microporous Membrane Oxygenators with Holding Clamp;2014-01-15
MAQUET CARDIOPULMONARY GmbH
QUADROX-iD Diffusion Membrane Oxygenators with Holding Clamp.2014-01-15
MAQUET CARDIOPULMONARY GmbH
QUADROX-i Microporous Membrane Oxygenators with Holding Clamp;2014-01-15
MAQUET CARDIOPULMONARY GmbH
QUADROX-iD Diffusion Membrane Oxygenators with Holding Clamp.2014-01-15
MAQUET CARDIOPULMONARY GmbH
QUADROX-i Microporous Membrane Oxygenators with Holding Clamp;2014-01-15
MAQUET CARDIOPULMONARY GmbH
Venous Hardshell Cardiotomy Reservoir with SOFTLINE Coating BO-VHK 71000 (vacuum sealed version)2013-11-20
MAQUET CARDIOPULMONARY GmbH
Venous Hardshell Cardiotomy Reservoir VHK 71000 (vacuum sealed version)2013-11-20
MAQUET CARDIOPULMONARY GmbH
Venous Hardshell Cardiotomy Reservoir VHK 700002013-11-20
MAQUET CARDIOPULMONARY GmbH
Accessories2013-11-20
MAQUET CARDIOPULMONARY GmbH
Venous Hardshell Cardiotomy Reservoir with SOFTLINE Coating BO-VHK 71000 (vacuum sealed version)2013-11-20
MAQUET CARDIOPULMONARY GmbH
Venous Hardshell Cardiotomy Reservoir VHK 71000 (vacuum sealed version)2013-11-20
MAQUET CARDIOPULMONARY GmbH
Venous Hardshell Cardiotomy Reservoir VHK 700002013-11-20
MAQUET CARDIOPULMONARY GmbH
Accessories2013-11-20
MAQUET CARDIOPULMONARY GmbH
Venous Hardshell Cardiotomy Reservoir with SOFTLINE Coating BO-VHK 71000 (vacuum sealed version)2013-11-20
MAQUET CARDIOPULMONARY GmbH
Venous Hardshell Cardiotomy Reservoir VHK 71000 (vacuum sealed version)2013-11-20
MAQUET CARDIOPULMONARY GmbH
Venous Hardshell Cardiotomy Reservoir VHK 700002013-11-20
MAQUET CARDIOPULMONARY GmbH
Accessories2013-11-20
MAQUET CARDIOPULMONARY GmbH
Arterial HLS-Cannula, 13 Fr. non-coated, with BIOLINE and with SOFTLINE Coating2013-08-01
MAQUET CARDIOPULMONARY GmbH
Hemoconcentrators BC 60 plus, BC 140 plus2013-07-02
MAQUET CARDIOPULMONARY GmbH
Elite-i Dual Lumen Catheters2013-06-10
MAQUET CARDIOPULMONARY GmbH
Venous Return Catheters, Two-Stage2012-09-20
MAQUET CARDIOPULMONARY GmbH
Venous Return Catheters, Two-Stage2012-09-20
MAQUET CARDIOPULMONARY GmbH
Venous Return Catheters2012-09-20
MAQUET CARDIOPULMONARY GmbH
Pediatric Arterial Cannulae2012-09-20
MAQUET CARDIOPULMONARY GmbH
Avalon Elite Vascular Access Kit2012-06-14
MAQUET CARDIOPULMONARY GmbH
Avalon Elite Bi-Caval Dual Lumen Catheter2012-06-14
MAQUET CARDIOPULMONARY GmbH
QUADROX-iR Small Adult w and w/o integ. art. filter, SOFTLIN2011-04-11
MAQUET CARDIOPULMONARY GmbH
QUADROX-iR Small Adult w and w/o integ. art. filter, SOFTLIN2011-04-11
MAQUET CARDIOPULMONARY GmbH
QUADROX-iR Small Adult w and w/o integ. art. filter, BIOLINE2011-04-11
MAQUET CARDIOPULMONARY GmbH
QUADROX-iR Small Adult w and w/o integ. art. filter, BIOLINE2011-04-11
MAQUET CARDIOPULMONARY GmbH
QUADROX-iR Adult w and w/o integ. art. filter, SOFTLINE2011-04-11
MAQUET CARDIOPULMONARY GmbH
QUADROX-iR Adult w and w/o integ. art. filter, SOFTLINE2011-04-11
MAQUET CARDIOPULMONARY GmbH
QUADROX-iR Adult w and w/o integ. art. filter, BIOLINE2011-04-11
MAQUET CARDIOPULMONARY GmbH
QUADROX-iR Adult w and w/o integ. art. filter, BIOLINE2011-04-11
MAQUET CARDIOPULMONARY GmbH
HLS-Set Advanced 7.0 and 5.0 (with BIOLINE Coating);2011-04-11
MAQUET CARDIOPULMONARY GmbH
HLS-Set Advanced 7.0 and 5.0 (with BIOLINE Coating);2011-04-11
MAQUET CARDIOPULMONARY GmbH
HIT-Set Advanced 7.0 and 5.0 (with SOFTLINE Coating);2011-04-11
MAQUET CARDIOPULMONARY GmbH
HIT-Set Advanced 7.0 and 5.0 (with SOFTLINE Coating);2011-04-11
MAQUET CARDIOPULMONARY GmbH
Cardiohelp-i and multiple accessories;2011-04-11
MAQUET CARDIOPULMONARY GmbH
Cardiohelp-i and multiple accessories;2011-04-11
MAQUET CARDIOPULMONARY GmbH
Cardiohelp multiple holders;2011-04-11
MAQUET CARDIOPULMONARY GmbH
Cardiohelp multiple holders;2011-04-11
MAQUET CARDIOPULMONARY GmbH
Cardiohelp Emergency Drive.2011-04-11
MAQUET CARDIOPULMONARY GmbH
Cardiohelp Emergency Drive.2011-04-11
MAQUET CARDIOPULMONARY GmbH
with and without integrated Arterial Filter2011-03-19
MAQUET CARDIOPULMONARY GmbH
with SOFTLINE and with BIOLINE Coating2011-03-19
MAQUET CARDIOPULMONARY GmbH
QUADROX-i Pediatric Microporous Membrane Oxygenator2011-03-19
MAQUET CARDIOPULMONARY GmbH
with and without integrated Arterial Filter2011-03-19
MAQUET CARDIOPULMONARY GmbH
with SOFTLINE and with BIOLINE Coating2011-03-19
MAQUET CARDIOPULMONARY GmbH
QUADROX-i Pediatric Microporous Membrane Oxygenator2011-03-19
MAQUET CARDIOPULMONARY GmbH
with and without integrated Arterial Filter2011-03-19
MAQUET CARDIOPULMONARY GmbH
with SOFTLINE and with BIOLINE Coating2011-03-19
MAQUET CARDIOPULMONARY GmbH
QUADROX-i Pediatric Microporous Membrane Oxygenator2011-03-19
MAQUET CARDIOPULMONARY GmbH
uncoated and SOFTLINE coated2011-03-19
MAQUET CARDIOPULMONARY GmbH
Neonatal, Pediatric Venous Hardshell Cardiotomy Reservoir2011-03-19
MAQUET CARDIOPULMONARY GmbH
uncoated and SOFTLINE coated2011-03-19
MAQUET CARDIOPULMONARY GmbH
Neonatal, Pediatric Venous Hardshell Cardiotomy Reservoir2011-03-19
MAQUET CARDIOPULMONARY GmbH
uncoated and SOFTLINE coated2011-03-19
MAQUET CARDIOPULMONARY GmbH
Neonatal, Pediatric Venous Hardshell Cardiotomy Reservoir2011-03-19
MAQUET CARDIOPULMONARY GmbH
Percutaneous Insertion Kit2011-03-19
MAQUET CARDIOPULMONARY GmbH
HLS-Cannulae non-coated, with SOFTLINE and BIOLINE Coating2011-03-19
MAQUET CARDIOPULMONARY GmbH
with and without integrated Arterial Filter2011-03-19
MAQUET CARDIOPULMONARY GmbH
with SOFTLINE and with BIOLINE Coating2011-03-19
MAQUET CARDIOPULMONARY GmbH
QUADROX-i Neonatal Microporous Membrane Oxygenator2011-03-19
MAQUET CARDIOPULMONARY GmbH
with and without integrated Arterial Filter2011-03-19
MAQUET CARDIOPULMONARY GmbH
with SOFTLINE and with BIOLINE Coating2011-03-19
MAQUET CARDIOPULMONARY GmbH
QUADROX-i Neonatal Microporous Membrane Oxygenator2011-03-19
MAQUET CARDIOPULMONARY GmbH
with and without integrated Arterial Filter2011-03-19
MAQUET CARDIOPULMONARY GmbH
with SOFTLINE and with BIOLINE Coating2011-03-19
MAQUET CARDIOPULMONARY GmbH
QUADROX-i Neonatal Microporous Membrane Oxygenator2011-03-19
MAQUET CARDIOPULMONARY GmbH
QUADROX-iD Adult Diffusion Membrane Oxygenator with SOFTLINE Coating or with BIOLINE Coating2011-01-21
MAQUET CARDIOPULMONARY GmbH
QUADROX-iD Adult Diffusion Membrane Oxygenator with SOFTLINE Coating or with BIOLINE Coating2011-01-21
MAQUET CARDIOPULMONARY GmbH
QUADROX-iD Pediatric Diffusion Membrane Oxygenator with BIOLINE Coating2010-05-05
MAQUET CARDIOPULMONARY GmbH
PLEGIOX Cardioplegia Heat Exchanger with SOFTLINE Coating2010-02-02
MAQUET CARDIOPULMONARY GmbH
Venous Softbag Reservoir Softline2010-01-07
MAQUET CARDIOPULMONARY GmbH
Venous Hardshell Reservoir Softline2010-01-07
MAQUET CARDIOPULMONARY GmbH
Customized Tubing Packs with SOFTLINE Coating2010-01-07
MAQUET CARDIOPULMONARY GmbH
Connectors with SOFTLINE Coating2010-01-07
MAQUET CARDIOPULMONARY GmbH
QUART Arterial Filter Softline2010-01-07
MAQUET CARDIOPULMONARY GmbH
RotaFlow Centrifugal Pump Softline2010-01-07
MAQUET CARDIOPULMONARY GmbH
QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Arterial Filter with BIOLINE Coating2009-12-22
MAQUET CARDIOPULMONARY GmbH
QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Arterial Filter with BIOLINE Coating2009-12-22
MAQUET CARDIOPULMONARY GmbH
QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Arterial Filter with BIOLINE Coating2009-12-22
MAQUET CARDIOPULMONARY GmbH
QUADROX-i Small Adult Microporous Membrane Oxygenator with or without Arterial Filter with SOFTLINE Coating with or with2009-12-22
MAQUET CARDIOPULMONARY GmbH
QUADROX-i Adult Microporous Membrane Oxygenator with and without Arterial Filter with BIOLINE Coating2009-06-26
MAQUET CARDIOPULMONARY GmbH
Blood Monitoring Unit BMU 402009-04-27
MAQUET CARDIOPULMONARY GmbH
Blood Monitoring Unit BMU 402009-04-27
MAQUET CARDIOPULMONARY GmbH
BMU sensor2009-04-27
MAQUET CARDIOPULMONARY GmbH
BMU sensor2009-04-27
MAQUET CARDIOPULMONARY GmbH
BMU cell2009-04-27
MAQUET CARDIOPULMONARY GmbH
BMU cell2009-04-27
MAQUET CARDIOPULMONARY GmbH
QUADROX-i Adult Microporous Membrane Oxygenator with or without integrated Arterial Filter with SOFTLINE Coating with or2009-02-24
MAQUET CARDIOPULMONARY GmbH
QUART Arterial Filter with BIOLINE Coating2008-12-04
MAQUET CARDIOPULMONARY GmbH
Venous Bubble Trap with and without BIOLINE Coating2008-12-04
MAQUET CARDIOPULMONARY GmbH
Customized Tubing Packs with BIOLINE Coating2008-12-04
MAQUET CARDIOPULMONARY GmbH
Connectors with BIOLINE Coating2008-12-04
MAQUET CARDIOPULMONARY GmbH
Customized Tubing Packs with BIOLINE Coating2008-12-04
MAQUET CARDIOPULMONARY GmbH
Connectors with BIOLINE Coating2008-12-04
MAQUET CARDIOPULMONARY GmbH
Customized Tubing Packs with BIOLINE Coating2008-12-04
MAQUET CARDIOPULMONARY GmbH
Connectors with BIOLINE Coating2008-12-04
MAQUET CARDIOPULMONARY GmbH
RotaFlow Centrifugal Pump with BIOLINE Coating2008-12-04
MAQUET CARDIOPULMONARY GmbH
Plegiox Cardioplegia Heat Exchanger2008-04-07
MAQUET CARDIOPULMONARY GmbH
Venous Softbag Reservoirs2008-01-09
MAQUET CARDIOPULMONARY GmbH
HL-20 Twin Pump2007-12-10
MAQUET CARDIOPULMONARY GmbH
Vent Catheters2007-12-10
MAQUET CARDIOPULMONARY GmbH
Vent Catheters2007-12-10
MAQUET CARDIOPULMONARY GmbH
Suction Devices2007-12-10
MAQUET CARDIOPULMONARY GmbH
Single Stage Venous Return Catheter2007-12-10
MAQUET CARDIOPULMONARY GmbH
Antegrade Cardioplegia Cannulae2007-12-10
MAQUET CARDIOPULMONARY GmbH
Retrograde Cardioplegia Cannula2007-12-10
MAQUET CARDIOPULMONARY GmbH
Dual Stage Venous Return Cannulae2007-12-10
MAQUET CARDIOPULMONARY GmbH
Dual Stage Venous Return Cannulae2007-12-10
MAQUET CARDIOPULMONARY GmbH
Arterial Perfusion Cannulae2007-12-10
MAQUET CARDIOPULMONARY GmbH
Arterial Perfusion Cannulae2007-12-10
MAQUET CARDIOPULMONARY GmbH
ELS Cannula2007-12-10
MAQUET CARDIOPULMONARY GmbH
RotaFlow Centrifugal Pump2007-12-07
MAQUET CARDIOPULMONARY GmbH
RotaFlow Centrifugal Pump2007-12-07
MAQUET CARDIOPULMONARY GmbH
RotaFlow Centrifugal Pump System2007-12-07
MAQUET CARDIOPULMONARY GmbH
RotaFlow Centrifugal Pump System2007-12-07
MAQUET CARDIOPULMONARY GmbH
Quart Arterial Filter2007-12-07
MAQUET CARDIOPULMONARY GmbH
Heater Cooler Unit, Model HCU 302007-06-27
MAQUET CARDIOPULMONARY GmbH
Heater Cooler Unit, Model HCU 302007-06-27
MAQUET CARDIOPULMONARY GmbH
Customized Tubing Packs2005-12-14
MAQUET CARDIOPULMONARY GmbH
Connectors2005-12-14
MAQUET CARDIOPULMONARY GmbH
VAVD CONTROLLER2004-10-19
MAQUET CARDIOPULMONARY GmbH
VAVD CONTROLLER2004-10-19
MAQUET CARDIOPULMONARY GmbH
Tubing Set for VAVD Controller2004-10-19
MAQUET CARDIOPULMONARY GmbH
Tubing Set for VAVD Controller2004-10-19
MAQUET CARDIOPULMONARY GmbH
Sprinter Cart (XL)2001-09-18
MAQUET CARDIOPULMONARY GmbH
Sprinter Cart (XL)2001-09-18
MAQUET CARDIOPULMONARY GmbH
Holders, multiple2001-09-18
MAQUET CARDIOPULMONARY GmbH
Holders, multiple2001-09-18
MAQUET CARDIOPULMONARY GmbH
HL-20 Integrated Perfusion System1995-05-16
MAQUET CARDIOPULMONARY GmbH
HL-20 Integrated Perfusion System1995-05-16

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020042243926Rotterdam,Netherlands -> New York/Newark Area, Newark, New JerseyMEDICAL PRODUCTSHS: 9018311012 PKG
2020010646535Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyMEDICAL PRODUCTS8 PAL
2019090620008Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyMEDICAL PRODUCTSHS-CODE:901831107 PAL
2019082834378Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyMEDICAL PRODUCTSHS-CODE:901831107 PAL
2019082260648Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyMEDICAL PRODUCTSHS-CODE:901831107 PAL

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