TYRX Inc.
FDA Regulatory Profile
TYRX Inc. appears in FDA public data with 3 recalls, 5 510(k) clearances, 4 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2541-2016, Class II) was initiated on June 29, 2016. Its most recent 510(k) clearance was granted on November 17, 2015.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 5
- Inspections
- 4
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2541-2016 | Class II | TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of impla | June 29, 2016 |
| Z-2539-2016 | Class II | TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pace | June 29, 2016 |
| Z-2540-2016 | Class II | TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted p | June 29, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K152678 | TYRX Neuro Antibacterial Envelope | November 17, 2015 |
| K132699 | AIGIS RX N (MEDIUM), AIGIS RX N (LARGE) | November 26, 2013 |
| K131007 | AIGIS RX N MEDIUM; AIGIS RX N LARGE | July 10, 2013 |
| K130943 | AIGIS RX R PM/ AIGIS RX R ICD | May 20, 2013 |
| K093524 | PIVIT A/B ST AND PIVIT A/B ST-R | March 26, 2010 |