Company ยท GB
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2014. Name variants (Inc, Corp, punctuation) are merged.
2510(k) clearances (0 in 12 months)
11recalls (2 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 29, 2026 | ARJOHUNTLEIGH POLSKA Sp. z.o.o. Carevo, Height-adjustable shower trolley, Model Number BAC1111-01 Open, Classified |
FSA | None listed |
| Apr 10, 2026 | ARJOHUNTLEIGH POLSKA Sp. z.o.o. Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US Open, Classified |
FSA | None listed |
| Dec 22, 2023 | ARJOHUNTLEIGH POLSKA Sp. z.o.o. Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules Open, Classified |
FNL | None listed |
| Dec 22, 2023 | ARJOHUNTLEIGH POLSKA Sp. z.o.o. Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules Open, Classified |
FNL | None listed |
| May 21, 2022 | ARJOHUNTLEIGH POLSKA Sp. z.o.o. Sara Plus Active Floor Lift Terminated |
FSA | None listed |
| Jun 10, 2021 | ARJOHUNTLEIGH POLSKA Sp. z.o.o. Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and IndiGo modules (retrofit kits) that can be installed on Citadel (model no. INDIDAA) Terminated |
FNL | None listed |
| Jul 21, 2020 | ARJOHUNTLEIGH POLSKA Sp. z.o.o. Bariatric Bed Frame System
The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment. Terminated |
FNL | None listed |
| Aug 22, 2019 | ARJOHUNTLEIGH POLSKA Sp. z.o.o. Concerto & Basic Shower Trolly, Model Numbers BAB1000-01 (UDI: (01)05055982788083), BAB1000CON6102 [(01)05056097364483], BAB1007-01 [(01)05055982796255], BAB1101-01 [(01)05055982787949], BAB1102-01 [ Terminated |
FSA | None listed |
| Oct 22, 2018 | ARJOHUNTLEIGH POLSKA Sp. z.o.o. ARJOHUNTLEIGH GETINGE GROUP
Flites
Passive Clip Sling - Product Usage: The Arjo Passive Clip Sling is a product intended for assisted transfer of patient/resident with limited ability to move. Designe Terminated |
FSA | None listed |
| Jun 29, 2016 | ARJOHUNTLEIGH POLSKA Sp. z.o.o. ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients. Terminated |
INQ | None listed |
| Sep 24, 2014 | ARJOHUNTLEIGH POLSKA Sp. z.o.o. Minstrel (with scale)
Product Usage: is a mobile passive hoist. It is intended for lifting and transporting adult residents on horizontal floors in hospitals, nursing homes or other health care facil Terminated |
FSA | None listed |