Ormed Mfg., Inc.: FDA clearances and approvals
Ormed Mfg., Inc. has 23 FDA 510(k) clearances (first 1983, latest 1994), across 7 product codes in 2 review panels. Median 510(k) review time: 27 days.
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 |
|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | 14 | 14 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 3 | 3 |
| KDC | Instrument, Surgical, Disposable | 2 | 2 |
| BXB | Exerciser, Powered | 1 | 1 |
| GDI | Dissector, Surgical, General & Plastic Surgery | 1 | 1 |
| KDD | Kit, Surgical Instrument, Disposable | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Ormed Mfg., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K931555 | ARTROMOT K2 CPM | BXB | 1994-01-31 | 307 |
| K882530 | TAPE STRUNG TONSIL SPONGE | EFQ | 1988-07-18 | 27 |
| K882529 | BUTCHER STRUNG TONSIL SPONGE | EFQ | 1988-07-18 | 27 |
| K882528 | CYLINDRICAL SPONGE | EFQ | 1988-07-18 | 27 |
| K882527 | GAUZE SPONGE | EFQ | 1988-07-18 | 27 |
| K880911 | BLUNT SPONGE | EFQ | 1988-03-17 | 14 |
| K880910 | ROUND STICK SPONGES | EFQ | 1988-03-17 | 14 |
| K880909 | TRACHEOTOMY SPONGES | EFQ | 1988-03-17 | 14 |
| K880907 | TRIANGLE SPONGE | EFQ | 1988-03-17 | 14 |
| K880854 | STRUNG ABSORBENT BALLS | EFQ | 1988-03-17 | 16 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ormed Mfg., Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Ormed Mfg., Inc. have?
Ormed Mfg., Inc. has 23 FDA 510(k) clearances (first 1983, latest 1994), across 7 product codes in 2 review panels.
How long does FDA take to clear Ormed Mfg., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Ormed Mfg., Inc.'s cleared 510(k)s is 27 days.
What devices does Ormed Mfg., Inc. make?
Its most frequent FDA product codes are EFQ (Gauze/Sponge, Internal, 14); GDY (Gauze/Sponge, Internal, X-Ray Detectable, 3); KDC (Instrument, Surgical, Disposable, 2).
Has Ormed Mfg., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Ormed Mfg., Inc. Related entities may recall under other names.
Next steps
- See all 23 Ormed Mfg., Inc. clearances with predicates and recalls
- Run predicate analysis for product code EFQ, Ormed Mfg., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.