Medical Device Manufacturer · US , San Leandro , CA

Berkeley Advanced Biomaterials, Inc. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 2003

13

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - Berkeley Advanced Biomaterials, Inc. Orthopedic ✕

13 devices

1-13 of 13

Cleared Mar 15, 2012

B-GENIN, R-GENIN

Orthopedic · 84d

Cleared Jun 23, 2010

B-GENIN AND R-GENIN

Orthopedic · 363d

Cleared Mar 24, 2010

BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY

Orthopedic · 261d

Cleared Jul 06, 2006

BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM

Orthopedic · 232d

Cleared Nov 03, 2005

GENEROS 80, GENEROS 60

Orthopedic · 112d

Cleared Jul 19, 2005

MARROW PLUS (M+)

Orthopedic · 26d

Cleared Apr 11, 2005

GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G,...

Orthopedic · 28d

Cleared Dec 14, 2004

Orthopedic · 78d

Cleared Aug 19, 2004

Orthopedic · 38d

Cleared Mar 05, 2004

CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY

Orthopedic · 17d

Cleared Feb 20, 2003

CEM-OSTETIC BONE

Orthopedic · 24d

Cleared Jan 30, 2003

Orthopedic · 87d

Cleared Jan 09, 2003

CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P

Orthopedic · 155d