Dornier Surgical Products, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Dornier Surgical Products, Inc.” (first 1998, latest 2001), across 1 product code in 1 review panel. Median 510(k) review time under this name: 63 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 9 | 9 |
Review panels
Most recent Dornier Surgical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K003993 | DORNIER MEDILAS D SKINPULSE LASER SYSTEM (SKINPULSE) | GEX | 2001-03-26 | 90 |
| K000072 | DORNIER MEDILAS D SKINPULSE | GEX | 2000-06-12 | 154 |
| K001243 | DORNIER MEDILAS H | GEX | 2000-05-24 | 36 |
| K993146 | DORNIER SCANNER HANDPIECE | GEX | 1999-11-08 | 49 |
| K991183 | DORNIER LASERTRODE FIBER | GEX | 1999-06-09 | 62 |
| K984591 | DORNIER MEDILAS H/2 | GEX | 1999-03-26 | 88 |
| K982629 | DORNIER MEDILAS D | GEX | 1998-09-14 | 48 |
| K981438 | DORNIER MEDILAS E | GEX | 1998-07-20 | 90 |
| K981718 | DORNIER MEDILAS H | GEX | 1998-07-17 | 63 |
Recalls
openFDA lists no recalls under a recalling firm named Dornier Surgical Products, Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Dornier Medtech America, Inc. (46 510(k)s)
- Dornier (3 510(k)s)
- Dornier Medtech America Inc (Dmta) (1 510(k)s)
- Dornier Medtech Systems (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dornier Surgical Products, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Dornier Surgical Products, Inc.” (first 1998, latest 2001), across 1 product code 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 Dornier Surgical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dornier Surgical Products, Inc. is 63 days.
Which FDA product codes appear under Dornier Surgical Products, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 9).
Next steps
- See all 9 Dornier Surgical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Dornier Surgical Products, Inc.'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.