Data / Medical devices / United States / Maiden Biosciences
Maiden Biosciences: FDA-registered device maker in Gaithersburg, MD, United States, 5 510(k) clearances
Maiden Biosciences is registered with the FDA (registration 3012973796) in Gaithersburg, MD, United States. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 16, 2024. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3012973796
- Address
- 101 Lakeforest Blvd. Suite 390, Gaithersburg, MD, United States, 20877
- Owner or operator
- Maiden Biosciences, Inc. (10052710)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- September 17, 2016
- Registered through
- 2026
- Brand names listed
- ECM3, ECM3 Ag, ECM3 Collagen Sheet Dressing
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Complaint file establishment | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 16, 2024 | K240809 | LUOFUCON® Silver Collagen Dressing | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| April 25, 2024 | K232796 | LUOFUCON® Collagen Particles (Collagen Wound Dressing) | KGN | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| September 20, 2022 | K213598 | LUOFUCON Collagen Wound Dressing | KGN | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| February 27, 2004 | K040211 | MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING | KGN | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| May 15, 2003 | K030921 | COLLAGEN TOPICAL WOUND DRESSING | KGN | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 16, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.