Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IsraelLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Natec Medical with 12 510(k) clearances. The most recent is a 510(k) clearance dated Dec 18, 2025: Amethyst HP PTA OTW 0.035 Catheter.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 18, 2025 | Amethyst HP PTA OTW 0.035 CatheterK251915 · LIT | 510(k) clearances |
| Dec 18, 2024 | Amethyst HP PTA OTW 0.035 CatheterK241040 · LIT | 510(k) clearances |
| Jun 29, 2022 | Ebony HP PTA OTW 0.035 CatheterK220410 · LIT | 510(k) clearances |
| Jul 9, 2021 | Tamarin Blue PTCA RX Dilatation CatheterK210012 · LOX | 510(k) clearances |
| Sep 3, 2015 | Ebony PTA .014 RX Pheripheral Dilatation CatheterK152230 · LIT | 510(k) clearances |
| Jun 28, 2015 | FILAO NC RX PTCA DILATATION CATHETERK141933 · LOX | 510(k) clearances |
| Jun 4, 2015 | Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire CatheterK143041 · LIT | 510(k) clearances |
| Mar 30, 2015 | Ebony PTA 0.035 Peripheral Dilatation CatheterK143036 · LIT | 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
