Qura S.R.L
ItalyFDA 510(k) applicant, unverified
- Devices
- 15
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
Catalogue
Search and filter all 15 devicesFDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 1
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2021
- 22 Mar 2021 Z-2277-2021 Class II Terminated Product labeled as sterile may not have been adequately sterilized. In addition, these devices were imported to the US distributor, but the devices are not 510(k) cleared in the US.
Frequently asked questions
How many devices does Qura S.R.L have in the registry?
The registry currently lists 15 devices for Qura S.R.L. Devices recorded under merged duplicate company entries are counted once.
Which registries list Qura S.R.L's devices?
Among its 15 most recently registered devices, Qura S.R.L has devices listed in FDA 510(k) (15 devices).
What risk classes do Qura S.R.L's devices fall under?
Among its 15 most recently registered devices, the classes recorded for Qura S.R.L's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Qura S.R.L?
FDA recall records list 1 recall initiated by Qura S.R.L, the most recent initiated on 2021-03-22. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Qura S.R.L in the registry?
The most recently registered devices listed for Qura S.R.L include Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS, Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U and Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor.