Berkeley Advanced Biomaterials
United Statesfrom the FDA registration address FDA establishment FEI 3014298539
Berkeley Advanced Biomaterials is a medical device manufacturer, with 395 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and Unclassified) and 1 FDA recall as of 13 Nov 2026.
- Devices
- 395
- Registrations
- FDA
- FDA recalls
- 11 ongoing
Registry facts
- Registries
- FDA GUDID 380
- FDA 510(k) 15
- Device classes
- FDA Class II 394
- FDA Unclassified 1
- FDA recalls
- Identifiers
- FDA FEI 3014298539
What Berkeley Advanced Biomaterials makes
Berkeley Advanced Biomaterials manufactures synthetic and composite bone matrix implants, including non-antimicrobial and cadaveric-donor/synthetic mineral bone grafts. Their portfolio also includes orthopaedic cement spacer moulds and convenience kits for surgical applications, such as putty formulations and mouldable matrices for bone reconstruction.
All listed devices fall under FDA Class II regulation and are recorded in the FDA’s Unique Device Identification (UDI) system. The company operates from the United States.
Catalogue
Search and filter all 395 devicesShowing 1-50 of 395
Company details
- FDA FEI number
- 3014298539
- Address
- 2800 Seventh Street, Berkeley, CA, 94710
FDA recalls
FDA recall records list 1 recall initiated by Berkeley Advanced Biomaterials, initiated on 2025-09-02. By recorded status: 1 ongoing. The reasons filed fall into these groups: labeling or instructions for use and packaging. 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 0
- 2023 0
- 2024 0
- 2025 1
- 2026 0
2025
- 2 Sep 2025 Z-0540-2026 Class II Ongoing Due to incorrect product label (Incorrect product name identified on outer packaging).
Frequently asked questions
How many devices does Berkeley Advanced Biomaterials have in the registry?
The registry currently lists 395 devices for Berkeley Advanced Biomaterials. Devices recorded under merged duplicate company entries are counted once.
Which registries list Berkeley Advanced Biomaterials's devices?
Among its 50 most recently registered devices, Berkeley Advanced Biomaterials has devices listed in FDA 510(k) (1 device) and FDA GUDID (49 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Berkeley Advanced Biomaterials's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Berkeley Advanced Biomaterials's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Berkeley Advanced Biomaterials?
FDA recall records list 1 recall initiated by Berkeley Advanced Biomaterials, the most recent initiated on 2 Sep 2025. 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 Berkeley Advanced Biomaterials in the registry?
The most recently registered devices listed for Berkeley Advanced Biomaterials include B-GENIN Strip BG5-50X5-06, B-GENIN Strip BG4-50X5-05, B-GENIN Strip BG6-50X5-07 and B-GENIN Strip BG4-100X5-10.