Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Geistlich Pharma AG — Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
126 daysmedian FDA review time
229 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260364 | Device 300419 Strip | Geistlich Pharma AG | 2026-06-02 | 118 | 0 |
| K260532 | Derma-Gide | Geistlich Pharma AG | 2026-03-19 | 30 | 0 |
| K251323 | Device 104 Particulate | Geistlich Pharma AG | 2026-01-22 | 268 | 0 |
| K252253 | Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich F | Geistlich Pharma AG | 2025-11-25 | 127 | 0 |
| K251062 | Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio | Geistlich Pharma AG | 2025-08-14 | 132 | 0 |
| K251556 | Device 300423 Granules | Geistlich Pharma AG | 2025-07-17 | 57 | 0 |
| K251786 | Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® | Geistlich Pharma AG | 2025-07-11 | 30 | 0 |
| K251613 | SwissGraft X | Geistlich Pharma AG | 2025-06-26 | 30 | 0 |
| K250833 | SwissMembrane X; SwissMembrane X Socket | Geistlich Pharma AG | 2025-04-15 | 27 | 0 |
| K242510 | Geistlich Bio-Flow® | Geistlich Pharma AG | 2025-03-07 | 196 | 0 |
| K241802 | Device 300397 Putty | Geistlich Pharma AG | 2024-11-08 | 140 | 0 |
| K240661 | Geistlich Bio-Oss® | Geistlich Pharma AG | 2024-07-12 | 126 | 0 |
| K213607 | Geistlich Wound Matrix PLUS | Geistlich Pharma AG | 2022-04-28 | 164 | 0 |
| K212463 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio- | Geistlich Pharma AG | 2022-04-05 | 242 | 0 |
| K203496 | Nexo-Gide Bilayer Collagen Membrane | Geistlich Pharma AG | 2021-07-14 | 229 | 0 |
| K210280 | Geistlich Mucograft®, Geistlich Mucograft® Seal | Geistlich Pharma AG | 2021-03-03 | 30 | 0 |
| K192042 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio- | Geistlich Pharma AG | 2019-08-29 | 29 | 0 |
| K190754 | Orthoss(R) | Geistlich Pharma AG | 2019-06-23 | 90 | 0 |
| K182838 | Geistlich Derma-Gide | Geistlich Pharma AG | 2018-11-08 | 30 | 0 |
| K171050 | Geistlich Fibro-Gide | Geistlich Pharma AG | 2017-11-09 | 216 | 0 |
| K171842 | Geistlich Wound Matrix | Geistlich Pharma AG | 2017-11-03 | 136 | 0 |
| K171643 | Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed | Geistlich Pharma AG | 2017-10-30 | 150 | 0 |
| K140518 | GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER | Geistlich Pharma AG | 2014-07-18 | 140 | 0 |
| K122894 | GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COM | Geistlich Pharma AG | 2013-02-15 | 148 | 0 |
| K120601 | GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLI | Geistlich Pharma AG | 2012-05-24 | 86 | 3 |
| K112572 | GEISTLICH COMBI-KIT COLLEGEN | Geistlich Pharma AG | 2011-12-28 | 113 | 0 |
| K112575 | GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO | Geistlich Pharma AG | 2011-12-27 | 112 | 0 |
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