Medart Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Medart Corp.” (first 1999, latest 2001), across 1 product code in 1 review panel. Median 510(k) review time under this name: 88 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 | 5 | 5 |
Review panels
Most recent Medart Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K010885 | UNI-LASER 470 | GEX | 2001-06-07 | 76 |
| K000503 | MEDART 520 COOLING SYSTEM | GEX | 2000-05-15 | 90 |
| K993815 | UNI-LASER 430 | GEX | 2000-05-11 | 183 |
| K991659 | UNI-LASER 425P DIODE LASER SYSTEM & ACCESSORIES | GEX | 1999-07-29 | 76 |
| K991297 | UNI-LASER 450P CO2 LASER SYSTEM & ACCESSORIES | GEX | 1999-07-12 | 88 |
Recalls
openFDA lists no recalls under a recalling firm named Medart Corp..
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.
- Medart A/S (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medart Corp.?
FDA lists 5 510(k) clearances under the applicant name “Medart Corp.” (first 1999, 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 Medart Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medart Corp. is 88 days.
Which FDA product codes appear under Medart Corp.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 5).
Next steps
- See all 5 Medart Corp. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Medart Corp.'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.