Data / Medical devices / United States / Advamedica Inc.
Advamedica Inc.: FDA-registered device maker in Cambridge, MA, United States, 4 510(k) clearances
Advamedica Inc. is registered with the FDA (registration 3017391151) in Cambridge, MA, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 24, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017391151
- Address
- Harvard Square 1 Mifflin place, Suite 400, Cambridge, MA, United States, 02138
- Owner or operator
- ADVAMEDICA INC. (10077783)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- June 9, 2021
- Registered through
- 2026
- Brand names listed
- AXIOSTAT PATCH, Ax-Surgi, Axiostat Gauze, Maxiocel Chitosan Wound Dressing
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | U | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Temporary, Internal Use Hemostatic | POD | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Complaint file establishment, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| August 24, 2023 | K212766 | Maxiocel Chitosan Wound Dressing | KGN | Substantially Equivalent | Advamedica, Inc. | accessdata.fda.gov |
| April 7, 2023 | K222909 | Axiostat Gauze | QSY | Substantially Equivalent | Advamedica, Inc. | accessdata.fda.gov |
| January 5, 2023 | K213198 | Ax-Surgi Surgical Hemostat | POD | Substantially Equivalent | Advamedica, Inc. | accessdata.fda.gov |
| April 15, 2021 | K202830 | Axiostat Patch | QSY | Substantially Equivalent | Advamedica, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Hemostatic Wound Dressing Without Thrombin Or Other Biologics
- All makers of Wound Dressing With Animal-Derived Material(S)
- All makers of Temporary, Internal Use Hemostatic
Updated August 24, 2023. 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.