Sartorius, Inc.
GermanyFDA applicant, unverified
- Devices
- 1
- FDA recalls
- 11 ongoing
At a glance
Market reach
- United States
- FDA recalls
What Sartorius, Inc. makes
Sartorius, Inc. manufactures the INFUSART, a medical device designed for intravenous infusion therapy, ensuring precise delivery of fluids and medications to patients.
The INFUSART is classified as a Class II device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Infusart Ref K844227
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Sartorius, Inc., initiated on 2022-03-11. By recorded status: 1 ongoing. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 1
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2022
- 11 Mar 2022 Z-0946-2022 Class II Ongoing The Virus Counter is an automated laboratory instrument that enables rapid quantification of intact viruses in solution. This instrument is not a medical device. The virus quantification is used in process development and manufacturing of various biotechnology products such as vaccines, gene therapy and personalized immunotherapy. Device is a Class 1 laser flow cytometer.
Frequently asked questions
How many devices does Sartorius, Inc. have in the registry?
The registry currently lists 1 device for Sartorius, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sartorius, Inc.'s devices?
Among its 1 most recently registered device, Sartorius, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Sartorius, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Sartorius, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Sartorius, Inc.?
FDA recall records list 1 recall initiated by Sartorius, Inc., the most recent initiated on 11 Mar 2022. 1 of them is recorded as ongoing. 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 Sartorius, Inc. in the registry?
The most recently registered devices listed for Sartorius, Inc. include INFUSART.