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
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2025 | Getinge 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 |
BSZ | K191027 |
| Nov 14, 2024 | Getinge 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 |
FQO | None listed |
| Nov 14, 2024 | Getinge 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 |
FQO | None listed |
| Nov 14, 2024 | Getinge 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 |
FQO | None listed |
| Nov 14, 2024 | Getinge 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 |
FQO | None listed |
| Nov 14, 2024 | Getinge 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 |
FQO | None listed |
| Nov 14, 2024 | Getinge 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 |
FQO | None listed |
| Nov 14, 2024 | Getinge 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 |
FQO | None listed |
| Nov 14, 2024 | Getinge 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 |
FQO | None listed |
| Jul 5, 2024 | Getinge Usa Sales Inc ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5 Open, Classified |
FQO | None listed |
| Jul 5, 2024 | Getinge Usa Sales Inc ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5 Open, Classified |
FQO | None listed |
| Jul 5, 2024 | Getinge Usa Sales Inc ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4 Open, Classified |
FQO | None listed |
| May 31, 2024 | Getinge 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 |
BSZ | K191027 |
| Feb 6, 2024 | Getinge Usa Sales Inc Flow-e Anesthesia System, model 6887900 Open, Classified |
BSZ | K133958 |
| Feb 6, 2024 | Getinge Usa Sales Inc Flow-c Anesthesia System, model 6887700 Open, Classified |
BSZ | K133958 |
| Feb 6, 2024 | Getinge Usa Sales Inc Flow-i C40 Anesthesia System, model 6677400 Open, Classified |
BSZ | K133958 |
| Feb 6, 2024 | Getinge Usa Sales Inc Flow-i C30 Anesthesia System, model 6677300 Open, Classified |
BSZ | K133958 |
| Feb 6, 2024 | Getinge Usa Sales Inc Flow-i C20 Anesthesia System, model 6677200 Open, Classified |
BSZ | K133958 |
| Jan 19, 2024 | Getinge 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 |
FSY | None listed |
| Jan 19, 2024 | Getinge 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 |
FSY | K954169 K970886 |
| Jan 19, 2024 | Getinge 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 |
FSY | None listed |
| Jan 19, 2024 | Getinge 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 |
FSY | K932451 |
| Jan 19, 2024 | Getinge 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 |
FSY | K982063 |
| Jan 19, 2024 | Getinge 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 |
FSY | K040735 |
| Jan 19, 2024 | Getinge Usa Sales Inc Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H3 BC - HM567811111C Open, Classified |
FSY | None listed |
| Jan 19, 2024 | Getinge 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 |
FSY | K030906 |
| Jan 19, 2024 | Getinge 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 |
FSY | K070442 |
| Jan 19, 2024 | Getinge 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 |
FTD | None listed |
| Jan 19, 2024 | Getinge 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 |
FTD | None listed |
| Jan 19, 2024 | Getinge 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 |
FTD | None listed |
| Jan 19, 2024 | Getinge 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 |
FTD | K113679 |
| Jan 19, 2024 | Getinge 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 |
FTD | K130513 |
| Jan 19, 2024 | Getinge 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 |
FTD | None listed |
| Oct 4, 2023 | Getinge 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 |
FQO | None listed |
| Jan 26, 2023 | Getinge Usa Sales Inc Getinge Flow-e Anesthesia System, Part No. 6887900 Open, Classified |
BSZ | K191027 |
| Jan 26, 2023 | Getinge Usa Sales Inc Getinge Flow-c Anesthesia System, Part No. 6887700 Open, Classified |
BSZ | K191027 |
| Jan 26, 2023 | Getinge 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 |
BSZ | K191027 |
| Dec 7, 2022 | Getinge Usa Sales Inc Flow-c Anesthesia System (Product Code 6887700)
Flow-e Anesthesia System (Product Code 6887900) Open, Classified |
BSZ | K191027 |
| Nov 15, 2022 | Getinge Usa Sales Inc Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN Open, Classified |
FQO | None listed |
| Jul 21, 2022 | Getinge 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 |
CBK | K192604 |
| Jul 20, 2022 | Getinge 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 |
CBK | K192604 K201874 |
| Jun 30, 2022 | Getinge 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 |
FSY | K130513 |
| Jun 23, 2022 | Getinge 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 |
BSZ | K191027 |
| Jun 23, 2022 | Getinge 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 |
BSZ | K191027 |
| Apr 13, 2022 | Getinge 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 |
MEC | None listed |
| Apr 13, 2022 | Getinge 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 |
MEC | None listed |
| Apr 1, 2022 | Getinge Usa Sales Inc Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW. Open, Classified |
MEC | None listed |
| Dec 9, 2021 | Getinge 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 |
BSZ | K191027 |