Company ยท US
Berkeley Advanced Biomaterials, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2026. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (2 in 12 months)
1recalls (1 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 22, 2026 | K260920 | Accelagen Advanced Surgical Collagen Matrix, 1cc (CG-01AA); Accelagen Advanced Surgical Collagen Matrix, 2cc (CG-02AA); Berkeley Advanced Biomaterials | KGN |
| Aug 27, 2026 | K260711 | Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matr Berkeley Advanced Biomaterials | KGN |
| Oct 30, 2017 | K170917 | Bi-Ostetic Bioactive Glass Foam Berkeley Advanced Biomaterials | MQV |
| Mar 15, 2012 | K113791 | B-GENIN, R-GENIN Berkeley Advanced Biomaterials, Inc. | MQV |
| Jun 23, 2010 | K091912 | B-GENIN AND R-GENIN Berkeley Advanced Biomaterials, Inc. | MQV |
| Mar 24, 2010 | K092046 | BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY Berkeley Advanced Biomaterials, Inc. | MQV |
| Jul 6, 2006 | K053213 | BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM Berkeley Advanced Biomaterials, Inc. | MQV |
| Nov 3, 2005 | K051914 | GENEROS 80, GENEROS 60 Berkeley Advanced Biomaterials, Inc. | MQV |
| Jul 19, 2005 | K051695 | MARROW PLUS (M+) Berkeley Advanced Biomaterials, Inc. | MQV |
| Apr 11, 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 SERIES Berkeley Advanced Biomaterials, Inc. | MQV |
| Dec 14, 2004 | K042636 | BIOPLUS Berkeley Advanced Biomaterials, Inc. | MQV |
| Aug 19, 2004 | K041889 | TRI-OSTETIC Berkeley Advanced Biomaterials, Inc. | MQV |
| Mar 5, 2004 | K040405 | CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY Berkeley Advanced Biomaterials, Inc. | MQV |
| Feb 20, 2003 | K030266 | CEM-OSTETIC BONE; CEMO-10G, CEMO-20G, CEMO-30G, CEMO-40G, CEMO-60G, CEM0-XXGC; CEMO-XYZ202005P, CEMO-XYZ20210P, CEMO-XYZ Berkeley Advanced Biomaterials, Inc. | MQV |
| Jan 30, 2003 | K023703 | BI-OSTETIC Berkeley Advanced Biomaterials, Inc. | MQV |
| Jan 9, 2003 | K022622 | CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P Berkeley Advanced Biomaterials, Inc. | MQV |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2025 | Berkeley Advanced Biomaterials, LLC Tribio Implant 7.5mm x 40mm REF M80 SB008
UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630
Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, p Open, Classified |
MQV | K170917 |