Berkeley Advanced Biomaterials, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 14
- Inspections
- 10
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0540-2026 | Class II | Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 | September 2, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K170917 | Bi-Ostetic Bioactive Glass Foam | October 30, 2017 |
| K113791 | B-GENIN, R-GENIN | March 15, 2012 |
| K091912 | B-GENIN AND R-GENIN | June 23, 2010 |
| K092046 | BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY | March 24, 2010 |
| K053213 | BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM | July 6, 2006 |
| K051914 | GENEROS 80, GENEROS 60 | November 3, 2005 |
| K051695 | MARROW PLUS (M+) | July 19, 2005 |
| K050666 | GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ | April 11, 2005 |
| K042636 | BIOPLUS | December 14, 2004 |
| K041889 | TRI-OSTETIC | August 19, 2004 |
| K040405 | CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY | March 5, 2004 |
| K030266 | CEM-OSTETIC BONE; CEMO-10G, CEMO-20G, CEMO-30G, CEMO-40G, CEMO-60G, CEM0-XXGC; CEMO-XYZ202005P, CEMO | February 20, 2003 |
| K023703 | BI-OSTETIC | January 30, 2003 |
| K022622 | CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P | January 9, 2003 |