Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled 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 13, 2026, FDA's public records list TYRX Inc. with 5 510(k) clearances and 3 device recalls. The most recent is a device recall dated Jun 29, 2016: TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of im….
| Date | Record | Source |
|---|---|---|
| Jun 29, 2016 | TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioveClass II · TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately v | Device recalls |
| Jun 29, 2016 | TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardiClass II · TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately v | Device recalls |
| Jun 29, 2016 | TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantableClass II · TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately v | Device recalls |
| Nov 17, 2015 | TYRX Neuro Antibacterial EnvelopeK152678 · FTL | 510(k) clearances |
| Nov 26, 2013 | AIGIS RX N (MEDIUM), AIGIS RX N (LARGE)K132699 · FTL | 510(k) clearances |
| Jul 10, 2013 | AIGIS RX N MEDIUM; AIGIS RX N LARGEK131007 · FTL | 510(k) clearances |
| May 20, 2013 | AIGIS RX R PM/ AIGIS RX R ICDK130943 · FTL | 510(k) clearances |
| Mar 26, 2010 | PIVIT A/B ST AND PIVIT A/B ST-RK093524 · 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
