Geistlich Pharma AG: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Geistlich Pharma AG” (first 2011, latest 2026), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 126 days. Since 2017 the median was 126 days, against 128 days for all cleared 510(k)s in the same product codes. 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 | 1 | 86 |
| 2013 | 1 | 148 |
| 2014 | 1 | 140 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 3 | 150 |
| 2018 | 1 | 30 |
| 2019 | 2 | 60 |
| 2020 | 0 | — |
| 2021 | 2 | 130 |
| 2022 | 2 | 203 |
| 2023 | 0 | — |
| 2024 | 2 | 133 |
| 2025 | 7 | 57 |
| 2026 | 3 | 118 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Geistlich Pharma AG took a median 126 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 128 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NPL | Barrier, Animal Source, Intraoral | 9 | 9 |
| NPM | Bone Grafting Material, Animal Source | 8 | 8 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 5 | 5 |
| MQV | Filler, Bone Void, Calcium Compound | 4 | 4 |
| FTM | Mesh, Surgical | 1 | 1 |
Review panels
- Dental (17)
- General and Plastic Surgery (6)
- Orthopedic (4)
Most recent Geistlich Pharma AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260364 | Device 300419 Strip | MQV | 2026-06-02 | 118 |
| K260532 | Derma-Gide | KGN | 2026-03-19 | 30 |
| K251323 | Device 104 Particulate | KGN | 2026-01-22 | 268 |
| K252253 | Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® | NPL | 2025-11-25 | 127 |
| K251062 | Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack | NPL | 2025-08-14 | 132 |
| K251556 | Device 300423 Granules | MQV | 2025-07-17 | 57 |
| K251786 | Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® | NPM | 2025-07-11 | 30 |
| K251613 | SwissGraft X | NPM | 2025-06-26 | 30 |
| K250833 | SwissMembrane X; SwissMembrane X Socket | NPL | 2025-04-15 | 27 |
| K242510 | Geistlich Bio-Flow® | NPM | 2025-03-07 | 196 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Geistlich Pharma AG.
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.
Device clinical trials
An industry sponsor named Geistlich Pharma AG is the lead sponsor of 6 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT03853356: Evidence For Fusion In Spine With Orthoss® (Active not recruiting, started 2019-01-18)
- NCT04260152: Evaluation of Geistlich Fibro-Gide® + CAF in Comparison to CTG + CAF for the Treatment of Recession Defects at 6 Months (Completed, started 2018-09-01)
- NCT02375750: Treatment of Peri-implantitis Lesions by Using Biomaterial (Completed, started 2014-09)
- NCT02356770: A Clinical Study to Investigate Collagen Matrix 10808 for Soft Tissue Volume Augmentation Around Single Implants (Completed, started 2012-02)
- NCT00902876: A Randomized Controlled Clinical Trial to Evaluate Safety and Effectiveness of CAF + Mucograft® Compared to CAF Alone in Patients With Gingival Recessions (Completed, started 2009-03)
Frequently asked questions
How many FDA 510(k) clearances are listed under Geistlich Pharma AG?
FDA lists 27 510(k) clearances under the applicant name “Geistlich Pharma AG” (first 2011, latest 2026), 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 AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Geistlich Pharma AG is 126 days. Since 2017: 126 days, versus 128 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Geistlich Pharma AG?
The most frequent FDA product codes under this applicant name are NPL (Barrier, Animal Source, Intraoral, 9); NPM (Bone Grafting Material, Animal Source, 8); KGN (Wound Dressing With Animal-Derived Material(S), 5).
Next steps
- See all 27 Geistlich Pharma AG clearances with predicates and recalls
- Run predicate analysis for product code NPL, Geistlich Pharma AG'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.