Aevumed, Inc.
Malvern, PA, US
AEVUMED, INC. appears in FDA device records in Malvern, PA. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Aevumed, Inc. between 2018 and 2026. The busiest year on record is 2025, with 2. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2025 | 2 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254306 | Aevumed FENIX Suture Anchor | MBI | Substantially Equivalent | |
| K260004 | Aevumed PROTEKT Suture Anchor | MBI | Substantially Equivalent | |
| K253040 | Aevumed FASE Suture Anchor | MBI | Substantially Equivalent | |
| K242895 | Aevumed PHANTOM Suture Anchors | MBI | Substantially Equivalent | |
| K223878 | Aevumed RAPID Suture Anchors | MBI | Substantially Equivalent | |
| K222363 | Aevumed PHANTOM™-LP Suture Anchors | MBI | Substantially Equivalent | |
| K180464 | AEVUMED PHANTOM Suture Anchors | MBI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3022393834 | 3022393834 | AEVUMED, INC. | 109 Great Valley Pkwy, Malvern, PA 19355 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain