Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FranceLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Vygon and its 4 subsidiaries with 61 510(k) clearances and 34 device recalls. The most recent is a 510(k) clearance dated Feb 26, 2025: pilot TLS.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Vygon and its 4 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Feb 26, 2025 | pilot TLSK241587 · LJS | 510(k) clearances |
| Dec 19, 2024 | NutrifitK243361 · FPD | 510(k) clearances |
| Aug 29, 2022 | Leaderflex Mini and Leaderflex NanoK212370 · FOZ | 510(k) clearances |
| Sep 24, 2019 | 4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001Class II · Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline | Device recalls |
| Nov 2, 2018 | Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL CatheterK181208 · PND | 510(k) clearances |
| Feb 26, 2018 | Vygon PICCsK172899 · LJS | 510(k) clearances |
| Oct 3, 2017 | Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.Class II · The Iodine Prep Pads within the Vygon IV Start Convenience Kits, had stability samples that were not meeting iodine assa | Device recalls |
| Jul 24, 2017 | 3-Way Standardbore Stopcock. Product Code: AMS-100.Class II · Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyve | Device recalls |
| Jul 24, 2017 | 19Ga x 1 Huber Needle Set. Product Code: MBS-1910.Class II · Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyve | Device recalls |
| Jul 24, 2017 | CVC Tray Pediatrics. Product Code: AMS-9335CP-2.Class II · Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyve | Device recalls |
| Jul 24, 2017 | Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352MClass II · Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyve | Device recalls |
| Jul 24, 2017 | 20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034.Class II · Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyve | Device recalls |
| Feb 20, 2017 | AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.Class II · Incorrect priming volume printed on the device package. | Device recalls |
| Feb 9, 2016 | Nutrisafe 2- ENFit AdaptorK151237 · PIO | 510(k) clearances |
| Jul 30, 2014 | LEADERFLEXK141026 · FOZ | 510(k) clearances |
| Dec 18, 2012 | NUTRISAFE 2 FEEDING TUBEK121105 · FPD | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
