Zomed Intl.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Zomed Intl.” (first 1995, latest 1996), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 70 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 6 | 6 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
Review panels
Most recent Zomed Intl. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964286 | ZOMED PASSIVE TEMPERATURE PROBE | FLL | 1996-11-19 | 22 |
| K962692 | ZOMED MODEL 30-6 MULTIELECTRODE ARRAY PROBE | GEI | 1996-09-19 | 70 |
| K960695 | MODEL 200C ELECTROSURGICAL PROBE | GEI | 1996-04-30 | 70 |
| K960694 | ZOMED 30F ELECTROSURGICAL PROBE | GEI | 1996-04-30 | 70 |
| K954965 | ZOMED MODEL 20 & 30 ELECTROSURGICAL PROBES | GEI | 1995-12-18 | 49 |
| K952072 | ZOMED MODEL 500 ELECTROSURGICAL GENERATOR MODEL 200 ELECTROSURGICAL PROBE | GEI | 1995-10-04 | 155 |
| K951659 | ZOMED MODEL 10 CAUTERY BIOPSY DEVICE | GEI | 1995-06-19 | 70 |
Recalls
openFDA lists no recalls under a recalling firm named Zomed Intl..
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 Zomed Intl.?
FDA lists 7 510(k) clearances under the applicant name “Zomed Intl.” (first 1995, latest 1996), 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 Zomed Intl.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zomed Intl. is 70 days.
Which FDA product codes appear under Zomed Intl.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 6); FLL (Continuous Measurement Thermometer, 1).
Next steps
- See all 7 Zomed Intl. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Zomed Intl.'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.