Medtrade Products , Ltd.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Medtrade Products , Ltd.” (first 2000, latest 2023), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 188 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 | 2 | 228 |
| 2013 | 0 | — |
| 2014 | 1 | 334 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 257 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 260 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medtrade Products , Ltd. took a median 258 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 210 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | 13 | 13 |
| FRO | Dressing, Wound, Drug | 2 | 2 |
| MDA | Elastomer, Silicone, For Scar Management | 2 | 2 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 1 | 1 |
| KMF | Bandage, Liquid | 1 | 1 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 1 | 1 |
| NTC | Nursing Pad, Hydrogel | 1 | 1 |
Review panels
Most recent Medtrade Products , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230589 | Celox Rapid X-Ray Gauze | QSY | 2023-11-17 | 260 |
| K161274 | Bondiloxs Topical Hemostatic Granules | QSY | 2017-01-18 | 257 |
| K132333 | BONDILOXS TOPICAL HEMOSTATIC DRESSING | QSY | 2014-06-25 | 334 |
| K120930 | CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING | FRO | 2012-10-26 | 213 |
| K113560 | CELOX GAUZE PRO | QSY | 2012-08-01 | 244 |
| K110386 | CELOX RAPID GAUZE | QSY | 2011-05-10 | 89 |
| K102965 | CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI | QSY | 2010-12-08 | 64 |
| K093519 | MEDTRADE PRODUCTS CELOX VASCULAR TOPICAL HEMOSTATIC GRANULES ON SHEET | QSY | 2010-01-14 | 62 |
| K091795 | MEDTRADE PRODUCTS CELOX TRAUMA GAUZE | QSY | 2009-11-20 | 156 |
| K090780 | MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC PASTE | QSY | 2009-11-20 | 242 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medtrade Products , 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medtrade Products Limited (2 510(k)s)
- Medtrade Product, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medtrade Products , Ltd.?
FDA lists 21 510(k) clearances under the applicant name “Medtrade Products , Ltd.” (first 2000, latest 2023), across 7 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 Medtrade Products , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medtrade Products , Ltd. is 188 days.
Which FDA product codes appear under Medtrade Products , Ltd.?
The most frequent FDA product codes under this applicant name are QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics, 13); FRO (Dressing, Wound, Drug, 2); MDA (Elastomer, Silicone, For Scar Management, 2).
Next steps
- See all 21 Medtrade Products , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code QSY, Medtrade Products , 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.