Data / Medical devices / Valvulotome / United States
FDA-registered makers of Valvulotome in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Valvulotome (product code MGZ). 6 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Valvulotome
- Product code
- MGZ
- Country
- United States
Makers of Valvulotome in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Lemaitre Vascular, Inc. | Burlington, MA, United States | Manufacturer | 4 | October 30, 2019 | 0 | 2 | 0 | api.fda.gov |
| LeMaitre Vascular Inc. | Billerica, MA, United States | Manufacturer | 4 | October 30, 2019 | 0 | 0 | 0 | api.fda.gov |
| LimFlow Inc. | Irvine, CA, United States | Specification developer | 2 | March 18, 2026 | 0 | 1 | 0 | api.fda.gov |
| Aveera Medical | San Clemente, CA, United States | Complaint file establishment, Manufacturer | 1 | July 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 1 | June 21, 1991 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 1 | June 21, 1991 | 0 | 0 | 0 | api.fda.gov |
| Scanlan International, Inc. | Saint Paul, MN, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.