Amdia Medical Products: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Amdia Medical Products” (first 1979, latest 1979), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 21 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 |
|---|---|---|---|
| DQD | Stethoscope, Electronic | 4 | 4 |
| GWZ | Percussor | 2 | 2 |
Review panels
- Cardiovascular (4)
- Neurology (2)
Most recent Amdia Medical Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K791338 | DUAL HEAD STETHOSCOPE | DQD | 1979-08-10 | 21 |
| K791335 | NURSESCOPE | DQD | 1979-08-10 | 21 |
| K791334 | MULTISCOPE | DQD | 1979-08-10 | 21 |
| K791333 | BOWLES STETHOSCOPE | DQD | 1979-08-10 | 21 |
| K791337 | TAYLOR NEUROLOGICAL HAMMER | GWZ | 1979-08-03 | 14 |
| K791336 | BUCKS NEUROLOGICAL HAMMER | GWZ | 1979-08-03 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Amdia Medical Products.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Amdia Medical Products?
FDA lists 6 510(k) clearances under the applicant name “Amdia Medical Products” (first 1979, latest 1979), across 2 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 Amdia Medical Products?
The median time from FDA receipt to decision across 510(k)s cleared under the name Amdia Medical Products is 21 days.
Which FDA product codes appear under Amdia Medical Products?
The most frequent FDA product codes under this applicant name are DQD (Stethoscope, Electronic, 4); GWZ (Percussor, 2).
Next steps
- See all 6 Amdia Medical Products clearances with predicates and recalls
- Run predicate analysis for product code DQD, Amdia Medical Products'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.