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Berkeley Advanced Biomaterials, LLC

FDA Regulatory Profile

Berkeley Advanced Biomaterials, LLC has 1 FDA recall, 10 inspections, 16 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Berkeley Advanced Biomaterials, LLC" and its spelling variant "Berkeley Advanced Biomaterials".

Latest recall
Z-0540-2026 · Class II · Sep 2, 2025
Latest inspection
Nov 22, 2024 · VAI
Latest 510(k)
Oct 22, 2026

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls1Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances16Nov 8, 2026File dated Nov 2, 2026Current
Inspections10Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Berkeley Advanced Biomaterials, LLC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Berkeley Advanced Biomaterials, LLC: FDA inspections per year 2017: 0 inspections020172018: 0 inspections020182019: 2 inspections220192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 0 inspections020232024: 1 inspections120242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500010
202410000
202300000
202200000
202100000
202000000
201920000
201800000
201700000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent recalls

1 recall record on Sep 2, 2025.

NumberClassProductDate
Z-0540-2026Class IITribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630…Sep 2, 2025

Recent FDA inspections

10 inspections from Mar 17, 2009 to Nov 22, 2024.

DateSiteProductClassificationFEI
Nov 22, 2024Berkeley, CABiologicsVoluntary Action Indicated (VAI)3014298539
Sep 5, 2019Berkeley, CADevicesNo Action Indicated (NAI)3014298539
Aug 2, 2019Berkeley, CABiologicsNo Action Indicated (NAI)3014298539
Jun 28, 2016Berkeley, CABiologicsNo Action Indicated (NAI)3014298539
Apr 18, 2016Berkeley, CADevicesNo Action Indicated (NAI)3014298539
Jul 12, 2013Berkeley, CADevicesNo Action Indicated (NAI)3014298539
Apr 12, 2013Berkeley, CABiologicsNo Action Indicated (NAI)3014298539
Feb 17, 2011Berkeley, CADevicesNo Action Indicated (NAI)3014298539
Dec 17, 2010Berkeley, CABiologicsNo Action Indicated (NAI)3014298539
Mar 17, 2009Berkeley, CABiologicsNo Action Indicated (NAI)3014298539
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3014298539Berkeley, CA10Nov 22, 2024

Recent 510(k) clearances

16 510(k) clearances from Jan 9, 2003 to Oct 22, 2026.

K-NumberDeviceDate
K260920Accelagen Advanced Surgical Collagen Matrix, 1cc (CG-01AA); Accelagen Advanced Surgical Collagen…Oct 22, 2026
K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…Aug 27, 2026
K170917Bi-Ostetic Bioactive Glass FoamOct 30, 2017
K113791B-GENIN, R-GENINMar 15, 2012
K091912B-GENIN AND R-GENINJun 23, 2010
K092046BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTYMar 24, 2010
K053213BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAMJul 6, 2006
K051914GENEROS 80, GENEROS 60Nov 3, 2005
K051695MARROW PLUS (M+)Jul 19, 2005
K050666GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ…Apr 11, 2005
K042636BIOPLUSDec 14, 2004
K041889TRI-OSTETICAug 19, 2004
K040405CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YYMar 5, 2004
K030266CEM-OSTETIC BONE; CEMO-10G, CEMO-20G, CEMO-30G, CEMO-40G, CEMO-60G, CEM0-XXGC; CEMO-XYZ202005P…Feb 20, 2003
K023703BI-OSTETICJan 30, 2003
K022622CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30PJan 9, 2003

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FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.