Data / Medical devices / United States / Aevumed, Inc.
Aevumed, Inc.: FDA-registered device maker in Malvern, PA, United States, 5 510(k) clearances
Aevumed, Inc. is registered with the FDA (registration 3022393834) in Malvern, PA, United States. It lists 1 device type. The FDA files 5 510(k) clearances under its listings, the newest dated October 21, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022393834
- Address
- 109 Great Valley Pkwy, Malvern, PA, United States, 19355
- Owner or operator
- Aevumed, Inc. (10084968)
- Roles
- Manufacturer
- First device listed
- April 21, 2022
- Registered through
- 2026
- Brand names listed
- FASE Suture Anchor, PHANTOM Suture Anchor, PHANTOM-LP Suture Anchor, RAPID Suture Anchor
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | 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 |
|---|---|---|---|---|---|---|
| October 21, 2025 | K253040 | Aevumed FASE Suture Anchor | MBI | Substantially Equivalent | Aevumed, Inc. | accessdata.fda.gov |
| August 6, 2025 | K242895 | Aevumed PHANTOM Suture Anchors | MBI | Substantially Equivalent | Aevumed, Inc. | accessdata.fda.gov |
| March 17, 2023 | K223878 | Aevumed RAPID Suture Anchors | MBI | Substantially Equivalent | Aevumed, Inc. | accessdata.fda.gov |
| November 28, 2022 | K222363 | Aevumed PHANTOM-LP Suture Anchors | MBI | Substantially Equivalent | Aevumed, Inc. | accessdata.fda.gov |
| May 31, 2018 | K180464 | AEVUMED PHANTOM Suture Anchors | MBI | Substantially Equivalent | Aevumed, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 21, 2025. 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.