ClearanceBrief
Company

Getinge Usa Sales Inc

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)
48recalls (0 in 12 months)
25recalls that name a 510(k)

Product codes

CodeDeviceRecords
BSZGas-Machine, Anesthesia14
FQOTable, Operating-Room, Ac-Powered13
FSYLight, Surgical, Ceiling Mounted10
FTDLamp, Surgical6
MECDisinfector, Medical Devices3
CBKVentilator, Continuous, Facility Use2

Latest 510(k) clearances

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

Latest recalls

DateFirm and productCodeLinked 510(k)
Feb 7, 2025Getinge Usa Sales Inc
Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during anesthesia.
Open, Classified
BSZK191027
Nov 14, 2024Getinge Usa Sales Inc
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item N
Open, Classified
FQONone listed
Nov 14, 2024Getinge Usa Sales Inc
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item N
Open, Classified
FQONone listed
Nov 14, 2024Getinge Usa Sales Inc
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item N
Open, Classified
FQONone listed
Nov 14, 2024Getinge Usa Sales Inc
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item N
Open, Classified
FQONone listed
Nov 14, 2024Getinge Usa Sales Inc
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item N
Open, Classified
FQONone listed
Nov 14, 2024Getinge Usa Sales Inc
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item N
Open, Classified
FQONone listed
Nov 14, 2024Getinge Usa Sales Inc
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item N
Open, Classified
FQONone listed
Nov 14, 2024Getinge Usa Sales Inc
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment, Item
Open, Classified
FQONone listed
Jul 5, 2024Getinge Usa Sales Inc
ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5
Open, Classified
FQONone listed
Jul 5, 2024Getinge Usa Sales Inc
ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5
Open, Classified
FQONone listed
Jul 5, 2024Getinge Usa Sales Inc
ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4
Open, Classified
FQONone listed
May 31, 2024Getinge Usa Sales Inc
Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of: Flow-i C20, Flow-i C30,Flow-i C40, Flow-c, Flow-e.
Open, Classified
BSZK191027
Feb 6, 2024Getinge Usa Sales Inc
Flow-e Anesthesia System, model 6887900
Open, Classified
BSZK133958
Feb 6, 2024Getinge Usa Sales Inc
Flow-c Anesthesia System, model 6887700
Open, Classified
BSZK133958
Feb 6, 2024Getinge Usa Sales Inc
Flow-i C40 Anesthesia System, model 6677400
Open, Classified
BSZK133958
Feb 6, 2024Getinge Usa Sales Inc
Flow-i C30 Anesthesia System, model 6677300
Open, Classified
BSZK133958
Feb 6, 2024Getinge Usa Sales Inc
Flow-i C20 Anesthesia System, model 6677200
Open, Classified
BSZK133958
Jan 19, 2024Getinge Usa Sales Inc
Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems. No Model Numbers.
Open, Classified
FSYNone listed
Jan 19, 2024Getinge Usa Sales Inc
Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numbers BLUE 30 - ARD569015111A, BLUE 30 - ARD569015111C, BLUE 30 - ARD569015131C, BLUE 30 - ARD569025111C, BLUE 30 - ARD569025
Open, Classified
FSYK954169
K970886
Jan 19, 2024Getinge Usa Sales Inc
Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C, G8G8FS DF - ARD568121131C
Open, Classified
FSYNone listed
Jan 19, 2024Getinge Usa Sales Inc
Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 - ARD567703001C, 4001 S/DF - ARD567211211C, 4001 SAD/DF - ARD56
Open, Classified
FSYK932451
Jan 19, 2024Getinge Usa Sales Inc
Maquet Prismalix OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 - ARD567703001C, 4001 S/DF - ARD567211211C, 4001 SAD/DF - ARD567221211
Open, Classified
FSYK982063
Jan 19, 2024Getinge Usa Sales Inc
Maquet XTen OR Light Systems, Model Numbers and Catalog Numbers 3001 HMD14 - ARD567732001C, X TEN DUO - ARD568221510C, X TEN DUO - ARD568221561C, X10AXL DF - ARD568211010C, X10AXL SF - ARD568231010C,
Open, Classified
FSYK040735
Jan 19, 2024Getinge Usa Sales Inc
Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H3 BC - HM567811111C
Open, Classified
FSYNone listed
Jan 19, 2024Getinge Usa Sales Inc
Maquet Axcel / Axcel + OR Light Systems, Model Numbers and Catalog Numbers AXL 5001 - ARD567501961C, AXL 5001S - ARD567505961C, AXL 5002 - ARD567501962C, AXL 5002S - ARD567505962C, AXL 5501 - ARD56750
Open, Classified
FSYK030906
Jan 19, 2024Getinge Usa Sales Inc
Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers EPS MB1 - ARDINT059002A, EPS MB1 - ARDINT059002C, EPS MB1 TR - ARDINT059000A, EPS MB1 TR - ARDINT059000C, EPS M
Open, Classified
FSYK070442
Jan 19, 2024Getinge Usa Sales Inc
Maquet Orchide OR Light Systems, Model Numbers and Catalog Numbers OHDII FHD QL VP01 - ARD568803935, OHDII FHD QL AIR03 U - ARD568803952, OHDII FHD QL AIR03 E - ARD568803967, OHDII FHD QL AIR04 E/U -
Open, Classified
FTDNone listed
Jan 19, 2024Getinge Usa Sales Inc
Maquet Equipment OR Light Systems, Model Numbers and Catalog Numbers BRAINLAB CAMERA - ARDEQT269000A, BRAINLAB CAMERA - ARDEQT269000C, BRAINLAB CAMERA - ARDEQT269001A, BRAINLAB CAMERA - ARDEQT269001C,
Open, Classified
FTDNone listed
Jan 19, 2024Getinge Usa Sales Inc
Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF - ARDPWT309001A, ROL PWDII50SF - ARDPWT309002A, ROL PWDII50SF - ARDPWT309009A, ROL PWDII50SF - ARDPWT309010A, ROL PWDII7
Open, Classified
FTDNone listed
Jan 19, 2024Getinge Usa Sales Inc
Maquet Lucea - Lucea10/40, Lucea50/100 OR Light Systems, Model Numbers and Catalog Numbers LCA 10 - ARD2LCA00040C, LCA 10 - ARDLCA109000C, LCA 10 - ARDLCA109002C, LCA 10 - ARDLCA109006C, LCA 10 - ARDL
Open, Classified
FTDK113679
Jan 19, 2024Getinge Usa Sales Inc
Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model Numbers and Catalog Numbers ROL B FOR VLT400SF STP - ARDROL309001A, ROL B FOR VLT400SF STP - ARDROL309001C, RO
Open, Classified
FTDK130513
Jan 19, 2024Getinge Usa Sales Inc
Maquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF - ARDPWT629100A, PWDII555DF - ARDPWT629101A, PWDII555SF - ARDPWT629102A, PWDII755DF - ARDPWT629103A, PWDII755SF - ARDPWT629
Open, Classified
FTDNone listed
Oct 4, 2023Getinge Usa Sales Inc
Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2
Open, Classified
FQONone listed
Jan 26, 2023Getinge Usa Sales Inc
Getinge Flow-e Anesthesia System, Part No. 6887900
Open, Classified
BSZK191027
Jan 26, 2023Getinge Usa Sales Inc
Getinge Flow-c Anesthesia System, Part No. 6887700
Open, Classified
BSZK191027
Jan 26, 2023Getinge Usa Sales Inc
Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
Open, Classified
BSZK191027
Dec 7, 2022Getinge Usa Sales Inc
Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
Open, Classified
BSZK191027
Nov 15, 2022Getinge Usa Sales Inc
Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN
Open, Classified
FQONone listed
Jul 21, 2022Getinge Usa Sales Inc
Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric and adult patients. Model Number: 6882000 (equipped with 688199
Open, Classified
CBKK192604
Jul 20, 2022Getinge Usa Sales Inc
Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air: Part Number 688200
Open, Classified
CBKK192604
K201874
Jun 30, 2022Getinge Usa Sales Inc
VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961 VLT600DF AIM STP ARDVST229000A VST60SF AIM ARDVST229001A VST60DF AIM
Open, Classified
FSYK130513
Jun 23, 2022Getinge Usa Sales Inc
Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887900
Terminated
BSZK191027
Jun 23, 2022Getinge Usa Sales Inc
Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700
Terminated
BSZK191027
Apr 13, 2022Getinge Usa Sales Inc
Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, Model: CM320 WUWD
Open, Classified
MECNone listed
Apr 13, 2022Getinge Usa Sales Inc
Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, etc. Model: CM320 WU
Open, Classified
MECNone listed
Apr 1, 2022Getinge Usa Sales Inc
Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.
Open, Classified
MECNone listed
Dec 9, 2021Getinge Usa Sales Inc
Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI: Flow-c Anesthesia System 6887700 07325710009765 Flow-e Anesthesia System 6887900 0
Open, Classified
BSZK191027
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