Geistlich-Pharma: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Geistlich-Pharma” (first 1983, latest 2004), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 173 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 | 11 | 11 |
| FRO | Dressing, Wound, Drug | 2 | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
| NPK | Barrier, Synthetic, Intraoral | 1 | 1 |
| NPM | Bone Grafting Material, Animal Source | 1 | 1 |
Review panels
- Dental (13)
- General and Plastic Surgery (2)
- Radiology (1)
Most recent Geistlich-Pharma 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033815 | BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN | NPM | 2004-01-15 | 37 |
| K014289 | ORTHOSS RESORBABLE BONE VOID FILLER | LYC | 2002-03-28 | 90 |
| K970569 | BIO-BLOCKS | LYC | 2000-08-14 | 1294 |
| K974399 | BIO-OSS COLLAGEN | LYC | 1998-09-16 | 299 |
| K970321 | BIO-OSS ANORGANIC BOVINE BONE | LYC | 1998-09-15 | 595 |
| K972817 | RESOR-PIN RESORBABLE MEMBRANE PIN | LYC | 1998-07-24 | 360 |
| K960724 | BIO-GIDE RESORBABLE BILAYER MEMBRANE | NPK | 1997-06-11 | 475 |
| K952619 | BIO-OSS CERAMIC | LYC | 1995-08-28 | 83 |
| K952618 | BIO-OSS | LYC | 1995-08-28 | 83 |
| K952617 | BIO-OSS | LYC | 1995-08-07 | 62 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Geistlich-Pharma.
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 Geistlich-Pharma?
FDA lists 16 510(k) clearances under the applicant name “Geistlich-Pharma” (first 1983, latest 2004), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Geistlich-Pharma?
The median time from FDA receipt to decision across 510(k)s cleared under the name Geistlich-Pharma is 173 days.
Which FDA product codes appear under Geistlich-Pharma?
The most frequent FDA product codes under this applicant name are LYC (Bone Grafting Material, Synthetic, 11); FRO (Dressing, Wound, Drug, 2); ITX (Transducer, Ultrasonic, Diagnostic, 1).
Next steps
- See all 16 Geistlich-Pharma clearances with predicates and recalls
- Run predicate analysis for product code LYC, Geistlich-Pharma'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.