Medx, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Medx, Inc.” (first 1987, latest 2008), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 46 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 |
|---|---|---|---|
| IYX | Camera, Scintillation (Gamma) | 4 | 4 |
| IKK | System, Isokinetic Testing And Evaluation | 3 | 3 |
| KPS | System, Tomography, Computed, Emission | 3 | 3 |
| IZH | System, X-Ray, Mammographic | 1 | 1 |
Review panels
- Radiology (8)
- Physical Medicine (3)
Most recent Medx, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082581 | C-QUEST | KPS | 2008-11-14 | 70 |
| K073456 | T-QUEST SYSTEM | IYX | 2007-12-20 | 10 |
| K041840 | MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM | KPS | 2004-08-20 | 43 |
| K012953 | GIOTTO IMAGE | IZH | 2001-11-30 | 87 |
| K993893 | MEDX INTECAM INTERFACE | KPS | 2000-02-10 | 86 |
| K911666 | MEDX MACHINE | IKK | 1991-07-03 | 82 |
| K896553 | MEDX CERVICAL EXTENSION TEST & REHAB MACHINE | IKK | 1990-01-02 | 46 |
| K895236 | MEDX REHABILITATION MACHINE | IKK | 1989-09-14 | 42 |
| K884661 | D-SCOPE III | IYX | 1989-04-12 | 156 |
| K872127 | D-SCOPE II AND D-SCOPE IIC | IYX | 1987-06-18 | 16 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medx, 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.
- Medx Electronics, Inc. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medx, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Medx, Inc.” (first 1987, latest 2008), across 4 product codes in 2 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 Medx, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medx, Inc. is 46 days.
Which FDA product codes appear under Medx, Inc.?
The most frequent FDA product codes under this applicant name are IYX (Camera, Scintillation (Gamma), 4); IKK (System, Isokinetic Testing And Evaluation, 3); KPS (System, Tomography, Computed, Emission, 3).
Next steps
- See all 11 Medx, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYX, Medx, 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.