Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Coors Biomedical Co. — Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

57 daysmedian FDA review time
100 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K863176ADDITIONAL CLINICAL USAGES FOR OSTEOGRAF/AR & AR+Coors Biomedical Co.1986-11-261000
K862324OSTEOGRAF/AR AND OSTEOGRAF/AR+Coors Biomedical Co.1986-08-15570
K862061OSTEOGRAF/AR+ PERMARIDGE HYDROXYLAPATITE, 18-40Coors Biomedical Co.1986-07-29600
K861084OSTEOGRAF/AR ALVEOLAR RID HYDROX, 18-40 MESHCoors Biomedical Co.1986-04-30400
K861083OSTEOGRAF/AR+(PLUS) ALVEOLAR RID HYDROX 18-40 MESHCoors Biomedical Co.1986-04-30400
K852742OSTEOGRAF AR ALVEOLAR RIDGE HYDROXYLAPATITE 18-40Coors Biomedical Co.1985-09-26910
K810822DENTAL PORCELAIN POWDERCoors Biomedical Co.1981-04-21280

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda