Omega-Med Intl., Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Omega-Med Intl., Inc.” (first 1981, latest 1984), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 27 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 |
|---|---|---|---|
| KDC | Instrument, Surgical, Disposable | 4 | 4 |
| DXC | Clamp, Vascular | 1 | 1 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Omega-Med Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K842603 | OMED DISPOS. INSTRUMENT GUARDS | — | 1984-09-05 | 62 |
| K832441 | SUTURE-AID BOOTIES | KDC | 1984-03-05 | 224 |
| K830484 | OMED IDENT-I-BAND | — | 1983-03-24 | 37 |
| K822284 | COMPLY NEUROMUSCULAR STIMULATOR | IPF | 1982-09-17 | 49 |
| K821334 | OMED FABRIC INSTRUMENT COVERS-RADIOPAQ | — | 1982-05-24 | 19 |
| K813499 | OMED DISPOSABLE BULLDOG | DXC | 1981-12-29 | 15 |
| K810883 | OMED SILICONE INSTRUMENT COVERS | KDC | 1981-04-23 | 22 |
| K810269 | OMED FABRIC INSTRUMENT COVERS | KDC | 1981-02-26 | 24 |
| K810260 | OMED SILICONE LOOPS | KDC | 1981-02-26 | 27 |
Recalls
openFDA lists no recalls under a recalling firm named Omega-Med Intl., 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Omega-Med Intl., Inc.?
FDA lists 9 510(k) clearances under the applicant name “Omega-Med Intl., Inc.” (first 1981, latest 1984), across 4 product codes in 3 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 Omega-Med Intl., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Omega-Med Intl., Inc. is 27 days.
Which FDA product codes appear under Omega-Med Intl., Inc.?
The most frequent FDA product codes under this applicant name are KDC (Instrument, Surgical, Disposable, 4); DXC (Clamp, Vascular, 1); IPF (Stimulator, Muscle, Powered, 1).
Next steps
- See all 9 Omega-Med Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code KDC, Omega-Med Intl., 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.