Medefield Pty. , Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Medefield Pty. , Ltd.” (first 1980, latest 1980), across 1 product code in 1 review panel. Median 510(k) review time under this name: 45 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 |
|---|---|---|---|
| KTA | Medium, Contrast, Radiologic | 6 | 6 |
Review panels
- Radiology (6)
Most recent Medefield Pty. , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K800843 | MEDEFIZZ A & MEDEFIZZ B | KTA | 1980-06-17 | 63 |
| K800840 | MEDEFOAM-2 | KTA | 1980-06-17 | 63 |
| K800844 | MEDEBAR XL | KTA | 1980-05-30 | 45 |
| K800842 | MEDEBAR XAC-90 | KTA | 1980-05-30 | 45 |
| K800841 | MEDEBAR M | KTA | 1980-05-30 | 45 |
| K800839 | MEDESCAN | KTA | 1980-05-30 | 45 |
Recalls
openFDA lists no recalls under a recalling firm named Medefield Pty. , Ltd..
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 Medefield Pty. , Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Medefield Pty. , Ltd.” (first 1980, latest 1980), 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 Medefield Pty. , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medefield Pty. , Ltd. is 45 days.
Which FDA product codes appear under Medefield Pty. , Ltd.?
The most frequent FDA product codes under this applicant name are KTA (Medium, Contrast, Radiologic, 6).
Next steps
- See all 6 Medefield Pty. , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KTA, Medefield Pty. , Ltd.'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.