3B Medical Inc
United Statesfrom the FDA registration address FDA establishment FEI 3042507287
- Devices
- 47
- Registrations
- FDA
- FDA recalls
- 33 ongoing
Catalogue
Search and filter all 47 devicesCompany details
- FDA FEI number
- 3042507287
- Address
- 1054 Gateway Park Dr, W Jefferson, OH, 43162
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 1
- 2024 1
- 2025 0
- 2026 1
2026
- 4 Feb 2026 Z-1815-2026 Class II Ongoing Devices which did not meet internal quality specifications were inadvertently distributed.
2024
- 27 Nov 2024 Z-0828-2025 Class II Ongoing The devices were inadvertently shipped after their expiration date.
2023
- 15 Jun 2023 Z-2740-2026 Class II Ongoing Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
Frequently asked questions
How many devices does 3B MEDICAL INC have in the registry?
The registry currently lists 47 devices for 3B MEDICAL INC. Devices recorded under merged duplicate company entries are counted once.
Which registries list 3B MEDICAL INC's devices?
Among its 47 most recently registered devices, 3B MEDICAL INC has devices listed in FDA 510(k) (10 devices) and FDA GUDID (37 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do 3B MEDICAL INC's devices fall under?
Among its 47 most recently registered devices, the classes recorded for 3B MEDICAL INC's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for 3B MEDICAL INC?
FDA recall records list 3 recalls initiated by 3B MEDICAL INC, the most recent initiated on 4 Feb 2026. 3 of them are 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 3B MEDICAL INC in the registry?
The most recently registered devices listed for 3B MEDICAL INC include iCodeConnect 3.0, 3B Medical, Inc. ELA6030, 3B Medical, Inc. CIR5550 and 3B Medical, Inc.'s Cirrus 5 CIR1005.