Ed. Geistlich Soehne AG Fuer Chemische Industrie: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Ed. Geistlich Soehne AG Fuer Chemische Industrie” (first 2003, latest 2010), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 160 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 |
|---|---|---|---|
| NPL | Barrier, Animal Source, Intraoral | 5 | 5 |
| NPM | Bone Grafting Material, Animal Source | 1 | 1 |
Review panels
- Dental (6)
Most recent Ed. Geistlich Soehne AG Fuer Chemische Industrie 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K092428 | BIO-OSS COLLAGEN | NPM | 2010-03-18 | 223 |
| K073711 | MUCOGRAFT COLLAGEN MATRIX | NPL | 2008-05-30 | 151 |
| K061244 | MUCOGRAFT | NPL | 2006-06-06 | 34 |
| K050446 | BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE | NPL | 2005-08-09 | 168 |
| K042197 | BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION | NPL | 2004-11-15 | 94 |
| K012423 | MUCOGRAFT | NPL | 2003-01-24 | 543 |
Recalls
openFDA lists no recalls under a recalling firm named Ed. Geistlich Soehne AG Fuer Chemische Industrie.
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 Ed. Geistlich Soehne AG Fuer Chemische Industrie?
FDA lists 6 510(k) clearances under the applicant name “Ed. Geistlich Soehne AG Fuer Chemische Industrie” (first 2003, latest 2010), 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 Ed. Geistlich Soehne AG Fuer Chemische Industrie?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ed. Geistlich Soehne AG Fuer Chemische Industrie is 160 days.
Which FDA product codes appear under Ed. Geistlich Soehne AG Fuer Chemische Industrie?
The most frequent FDA product codes under this applicant name are NPL (Barrier, Animal Source, Intraoral, 5); NPM (Bone Grafting Material, Animal Source, 1).
Next steps
- See all 6 Ed. Geistlich Soehne AG Fuer Chemische Industrie clearances with predicates and recalls
- Run predicate analysis for product code NPL, Ed. Geistlich Soehne AG Fuer Chemische Industrie'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.