Is this your brand? Sign in to claim ownership.
Sign in to claim this brandBerkeley Advanced Biomaterials
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 2800 Seventh Street, Berkeley, CA, 94710
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3014298539
- DUNS Number
- —
Catalogue (346)
Page 4 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bi-Ostetic Foam Strip | BF2-50X10-05 | FDA UDI | Class II | Active |
| Bi-Ostetic Foam Strip | BF2-50X25-10 | FDA UDI | Class II | Active |
| Bi-Ostetic Granules | BiO-00GN | FDA UDI | Class II | Active |
| R-GENIN Putty | RG-00P | FDA UDI | Class II | Active |
| Cem-Ostetic Putty | CemO-03P | FDA UDI | Class II | Active |
| Bi-Ostetic Granules | BiO-03GN | FDA UDI | Class II | Active |
| Bi-Ostetic Bioactive Glass Foam | AA-05P | FDA UDI | Class II | Active |
| AlexiGlass Bioactive Glass Strip | AB-3506 | FDA UDI | Class II | Active |
| Cem-Ostetic Cylinder | CemO-DZ1030P | FDA UDI | Class II | Active |
| Bi-Ostetic Granules | BiO-02G-00X5 | FDA UDI | Class II | Active |
| BiSyntek Strip | ZS7-S125-5 | FDA UDI | Class II | Active |
| Bi-Ostetic Bioactive Glass Foam | AA-02P | FDA UDI | Class II | Active |
| Cem-Ostetic Putty | CemO-04P | FDA UDI | Class II | Active |
| K2M VENADO HA/TCP Cancellous Granules | 4815-T6060 | FDA UDI | Class II | Active |
| Cem-Ostetic Putty | CemO-20PG | FDA UDI | Class II | Active |
| PURbridge™ Active BioGlass Strip | PURbridge-100x20x5 | FDA UDI | Class II | Active |
| EvoGraft | EBF2-50X10-05 | FDA UDI | Class II | Active |
| OptiFuse Bi-Ostetic Foam Strip | OM2-50X10-05 | FDA UDI | Class II | Active |
| K2M VENADO HA/TCP Granules-Collagen Strip | 4815-T5011 | FDA UDI | Class II | Active |
| AlexiGlass Bioactive Glass Strip | AB-3505 | FDA UDI | Class II | Active |
| Cem-Ostetic Putty | CemO-02P | FDA UDI | Class II | Active |
| Bi-Ostetic Bioactive Glass Foam | AA1-6D40-01 | FDA UDI | Class II | Active |
| Cem-Ostetic Putty | CemO-10M | FDA UDI | Class II | Active |
| FBM-Osteo Foam Granules-Collagen Strip | FBO2-50X10-05 | FDA UDI | Class II | Active |
| STRATOFUSE HA/TCP Putty | BA44-000001 | FDA UDI | Class II | Active |
| Cem-Ostetic Putty | CemO-00P | FDA UDI | Class II | Active |
| EvoGraft | EBF2-50X10-02 | FDA UDI | Class II | Active |
| BiSyntek Strip | ZS7-S9022-10 | FDA UDI | Class II | Active |
| Bi-Ostetic Bioactive Glass Foam | AA1-5D40-01 | FDA UDI | Class II | Active |
| Bi-Ostetic Foam Strip | BF1-50X10-01 | FDA UDI | Class II | Active |
| Tribio® DP Cotton Wedge | C10 SWC07 | FDA UDI | Class II | Active |
| BiSyntek Strip | ZS7-2S52-8 | FDA UDI | Class II | Active |
| BiSyntek BA Glass Strip | ZS8-S125-12 | FDA UDI | Class II | Active |
| K2M VENADO HA/TCP Granules-Collagen Strip | 4815-T5022 | FDA UDI | Class II | Active |
| B-GENIN Putty | BG-10P | FDA UDI | Class II | Active |
| OsteoBoost, 10 cc | OB-10P | FDA UDI | Class II | Active |
| R-GENIN Putty | RG-01P | FDA UDI | Class II | Active |
| STRATOFUSE Strip | BA42-501005 | FDA UDI | Class II | Active |
| Cem-Ostetic Putty | CemO-05M | FDA UDI | Class II | Active |
| K2M VENADO HA/TCP Cancellous Granules | 4815-T0525 | FDA UDI | Class II | Active |
| Bi-Ostetic Foam Strip | BF1-90X22-10 | FDA UDI | Class II | Active |
| Bi-Ostetic Bioactive Glass Foam | AA2-50X10-02 | FDA UDI | Class II | Active |
| R-GENIN Strip | RGT-100X25-10 | FDA UDI | Class II | Active |
| R-GENIN Strip | RG2-50X20-08 | FDA UDI | Class II | Active |
| B-GENIN Putty | BG-05P | FDA UDI | Class II | Active |
| Tribio® DP Evans Wedge | C10 SWE10 | FDA UDI | Class II | Active |
| Bi-Ostetic Foam Strip | BF1-15X15-01 | FDA UDI | Class II | Active |
| Cem-Ostetic Putty | CemO-00M | FDA UDI | Class II | Active |
| Bi-Ostetic Granules | BiO-10GN | FDA UDI | Class II | Active |
| EvoGraft | EBF1-90X22-07 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 2, 2025 | Z-0540-2026 | — | open, classified | Due to incorrect product label (Incorrect product name identified on outer packaging). |