Medical device makerLabelled 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 14, 2026, FDA's public records list International Life Sciences with 4 510(k) clearances and 3 device recalls. The most recent is a 510(k) clearance dated Apr 9, 2026: Artelon Convenience Kits.
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.
| Apr 9, 2026 | Artelon Convenience KitsK260317 · QWJ | 510(k) clearances |
| Feb 6, 2026 | Artelon FlexBand Dynamic Matrix Ref: 31057Class II · Augmentation devices failed bacterial endotoxin testing. | Device recalls |
| Feb 6, 2026 | Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)Class II · Augmentation devices failed bacterial endotoxin testing. | Device recalls |
| Feb 6, 2026 | Artelon FlexBand Plus Ref: 41054 & 41057Class II · Augmentation devices failed bacterial endotoxin testing. | Device recalls |
| May 26, 2023 | FlexBand; FlexPatch; FlexBand PlusK230316 · OWW | 510(k) clearances |
| Sep 2, 2020 | ATL AnchorsK200503 · MBI | 510(k) clearances |
| Sep 27, 2019 | FlexBand PlusK192112 · FTL | 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
