ClearanceBrief
Company

Maquet Cardiovascular Us Sales, Llc

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)
64recalls (0 in 12 months)
48recalls that name a 510(k)

Product codes

CodeDeviceRecords
FTDLamp, Surgical13
DTZOxygenator, Cardiopulmonary Bypass11
DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass5
FQOTable, Operating-Room, Ac-Powered5
MECDisinfector, Medical Devices5
BSZGas-Machine, Anesthesia4
KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type4
DWCController, Temperature, Cardiopulmonary Bypass2
FWZOperating Room Accessories Table Tray2
LGXTable, Examination, Medical, Powered2
BTICompressor, Air, Portable1
CBKVentilator, Continuous, Facility Use1
CBNApparatus, Gas-Scavenging1
DREDilator, Vessel, For Percutaneous Catheterization1
DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass1
DTRHeat-Exchanger, Cardiopulmonary Bypass1
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass1
FGYCannula, Injection1
FSYLight, Surgical, Ceiling Mounted1
KRIAccessory Equipment, Cardiopulmonary Bypass1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Nov 20, 2020Maquet Cardiovascular Us Sales, Llc
HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorpore
Terminated
DTZK112360
Nov 20, 2020Maquet Cardiovascular Us Sales, Llc
HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extraco
Terminated
DTZK112360
Sep 30, 2020Maquet Cardiovascular Us Sales, Llc
Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which req
Terminated
DRYK090147
Sep 24, 2020Maquet Cardiovascular Us Sales, Llc
Yuno II Mobile Operating Table - Product Usage: support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Part 143302F0 (US
Terminated
FQONone listed
Sep 24, 2020Maquet Cardiovascular Us Sales, Llc
Yuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Part 14
Terminated
FQONone listed
Aug 7, 2020Maquet Cardiovascular Us Sales, Llc
Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that uses a method other than revolving rollers to pump the blood
Terminated
KFMK991864
Jun 18, 2020Maquet Cardiovascular Us Sales, Llc
Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: 701047495 - Product Usage: The Holder HKHZ 19 is an accessory to QUADROX i and QUADROX iD Neonatal
Terminated
KRINone listed
Feb 20, 2020Maquet Cardiovascular Us Sales, Llc
Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
Terminated
DREK081940
Feb 18, 2020Maquet Cardiovascular Us Sales, Llc
Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203
Terminated
MECNone listed
Jan 16, 2020Maquet Cardiovascular Us Sales, Llc
Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or h
Terminated
MECNone listed
Jan 16, 2020Maquet Cardiovascular Us Sales, Llc
Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or h
Terminated
MECNone listed
Dec 3, 2019Maquet Cardiovascular Us Sales, Llc
Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
Terminated
KFMK991864
Jul 11, 2019Maquet Cardiovascular Us Sales, Llc
Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794
Terminated
DTZK112360
Jun 21, 2019Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF
Terminated
FTDK130513
Jun 21, 2019Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF
Terminated
FTDK130513
Jun 21, 2019Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF
Terminated
FTDK130513
Jun 21, 2019Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: VST60SF
Terminated
FTDK130513
Jun 21, 2019Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM
Terminated
FTDK130513
Jun 21, 2019Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: VST66SF AIM
Terminated
FTDK130513
Jun 21, 2019Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM
Terminated
FTDK130513
Jun 21, 2019Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM
Terminated
FTDK130513
Jun 21, 2019Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP
Terminated
FTDK130513
Jun 21, 2019Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP
Terminated
FTDK130513
Jun 21, 2019Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP
Terminated
FTDK130513
Jun 21, 2019Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP
Terminated
FTDK130513
Jun 21, 2019Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP
Terminated
FTDK130513
Jun 4, 2019Maquet Cardiovascular Us Sales, Llc
GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 (4) Part 720001F0 (5) Part 710001B2 (6) Part 710001B0 (7) Part 710001F0 Product Usage: The Meera Mob
Terminated
LGXNone listed
May 20, 2019Maquet Cardiovascular Us Sales, Llc
Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 Product Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories w
Terminated
MECNone listed
May 20, 2019Maquet Cardiovascular Us Sales, Llc
Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product Usage: Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laborat
Terminated
MECNone listed
Mar 28, 2019Maquet Cardiovascular Us Sales, Llc
Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails.
Terminated
DTQK102726
Nov 28, 2018Maquet Cardiovascular Us Sales, Llc
QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055207 The membrane oxygenator QUADROXi Neonatal is intended for use in ext
Terminated
DTZK102464
K141432
Nov 28, 2018Maquet Cardiovascular Us Sales, Llc
QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The membrane oxygenator QUADROXi Neonatal is intended for use in
Terminated
DTZK102464
K141432
Sep 27, 2016Maquet Cardiovascular Us Sales, Llc
Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extra corporeal circulation and for b
Terminated
DWCK031544
Aug 12, 2016Maquet Cardiovascular Us Sales, Llc
The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests on a Maquet operating room table immediately before, during and after surgical i
Terminated
FQONone listed
Mar 3, 2016Maquet Cardiovascular Us Sales, Llc
Maquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH, Used to support the upper and lower extremities immediately before, during and after fracture surgery. The Extension Device
Terminated
FQONone listed
Feb 23, 2016Maquet Cardiovascular Us Sales, Llc
Custom Tubing Packs Custom tubing pack for oxygenators
Terminated
KFMK080592
Feb 23, 2016Maquet Cardiovascular Us Sales, Llc
Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator
Terminated
KFMK080470
Feb 23, 2016Maquet Cardiovascular Us Sales, Llc
HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator
Terminated
DTQK102726
Feb 23, 2016Maquet Cardiovascular Us Sales, Llc
QUADROX-i oxygenators Custom tubing packs for the oxygenator
Terminated
DTZK082117
K090689 +4
Feb 22, 2016Maquet Cardiovascular Us Sales, Llc
Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to
Terminated
BSZK133958
Jan 5, 2016Maquet Cardiovascular Us Sales, Llc
Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product Usage: The Heater Cooler Unit (HCU) 30 is intended to circulate water through heat exchange circuits to warm or coo
Terminated
DWCK031544
Nov 9, 2015Maquet Cardiovascular Us Sales, Llc
Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer: Maquet GmbH, Germany The MAQUET Adjustable Positioning Elements are designed for the placement and positioning
Terminated
FWZNone listed
Nov 9, 2015Maquet Cardiovascular Us Sales, Llc
Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacturer: Maquet GmbH, Germany. Patient positioners. The MAQUET Adjustable Positioning Elements are designed for the placement an
Terminated
FWZNone listed
Jul 17, 2015Maquet Cardiovascular Us Sales, Llc
Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co.
Terminated
FQONone listed
Jul 15, 2015Maquet Cardiovascular Us Sales, Llc
The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847 FLOW-i Anesthesia System: Is indicated for administering inhalation anesthesia while controlling the entire
Terminated
BSZK133958
Jul 7, 2015Maquet Cardiovascular Us Sales, Llc
The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling surgical light systems
Terminated
FSYK040735
K070442 +1
Jun 8, 2015Maquet Cardiovascular Us Sales, Llc
FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.
Terminated
BSZK133958
May 28, 2015Maquet Cardiovascular Us Sales, Llc
HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product Usage: HLS/HIT Set Advanced: The CARDIO HELP System in configuration with the HLS/HIT Set Advanced is intended to be used wi
Terminated
DTQK102726
May 28, 2015Maquet Cardiovascular Us Sales, Llc
Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in
Terminated
DTZK132829
Feb 27, 2015Maquet Cardiovascular Us Sales, Llc
Servo-I ventilator system CO2 analyzer. Part number 65 23 588.
Terminated
CBNK123149

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