Intera Oncology
United Statesfrom the FDA registration address FDA FEI 3015537318
- Devices
- 14
- Registrations
- FDA
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
Catalogue
Search and filter all 14 devicesCompany details
- FDA FEI number
- 3015537318
- Address
- 180 Wells Avenue, Newton, MA, 02459
FDA recalls
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
- 10 Jul 2022 Z-1522-2022 Class I Terminated Higher than expected flow rate.
Frequently asked questions
How many devices does Intera Oncology have in the registry?
The registry currently lists 14 devices for Intera Oncology. Devices recorded under merged duplicate company entries are counted once.
Which registries list Intera Oncology's devices?
Among its 14 most recently registered devices, Intera Oncology has devices listed in FDA 510(k) (2 devices), FDA PMA (2 devices) and FDA GUDID (10 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Intera Oncology's devices fall under?
Among its 14 most recently registered devices, the classes recorded for Intera Oncology's devices are Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Intera Oncology?
FDA recall records list 1 recall initiated by Intera Oncology, the most recent initiated on 10 Jul 2022. 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 Intera Oncology in the registry?
The most recently registered devices listed for Intera Oncology include INTERA AP-07004, INTERA IP-37957, INTERA AP-04011 and INTERA AP-04032-5.