Coors Biomedical Co.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Coors Biomedical Co.” (first 1981, latest 1986), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 57 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYC | Bone Grafting Material, Synthetic | 6 | 6 |
| EIH | Powder, Porcelain | 1 | 1 |
Review panels
- Dental (7)
Most recent Coors Biomedical Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K863176 | ADDITIONAL CLINICAL USAGES FOR OSTEOGRAF/AR & AR+ | LYC | 1986-11-26 | 100 |
| K862324 | OSTEOGRAF/AR AND OSTEOGRAF/AR+ | LYC | 1986-08-15 | 57 |
| K862061 | OSTEOGRAF/AR+ PERMARIDGE HYDROXYLAPATITE, 18-40 | LYC | 1986-07-29 | 60 |
| K861084 | OSTEOGRAF/AR ALVEOLAR RID HYDROX, 18-40 MESH | LYC | 1986-04-30 | 40 |
| K861083 | OSTEOGRAF/AR+(PLUS) ALVEOLAR RID HYDROX 18-40 MESH | LYC | 1986-04-30 | 40 |
| K852742 | OSTEOGRAF AR ALVEOLAR RIDGE HYDROXYLAPATITE 18-40 | LYC | 1985-09-26 | 91 |
| K810822 | DENTAL PORCELAIN POWDER | EIH | 1981-04-21 | 28 |
Recalls
openFDA lists no recalls under a recalling firm named Coors Biomedical Co..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Coors Biomedical Co.?
FDA lists 7 510(k) clearances under the applicant name “Coors Biomedical Co.” (first 1981, latest 1986), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Coors Biomedical Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Coors Biomedical Co. is 57 days.
Which FDA product codes appear under Coors Biomedical Co.?
The most frequent FDA product codes under this applicant name are LYC (Bone Grafting Material, Synthetic, 6); EIH (Powder, Porcelain, 1).
Next steps
- See all 7 Coors Biomedical Co. clearances with predicates and recalls
- Run predicate analysis for product code LYC, Coors Biomedical Co.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.