Company ยท US
Tyrx, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2015. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FTL | Mesh, Surgical, Polymeric | 8 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 17, 2015 | K152678 | TYRX Neuro Antibacterial Envelope Tyrx, Inc. | FTL |
| Nov 26, 2013 | K132699 | AIGIS RX N (MEDIUM), AIGIS RX N (LARGE) Tyrx, Inc. | FTL |
| Jul 10, 2013 | K131007 | AIGIS RX N MEDIUM; AIGIS RX N LARGE Tyrx, Inc. | FTL |
| May 20, 2013 | K130943 | AIGIS RX R PM/ AIGIS RX R ICD Tyrx, Inc. | FTL |
| Mar 26, 2010 | K093524 | PIVIT A/B ST AND PIVIT A/B ST-R Tyrx, Inc. | FTL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2016 | TYRX Inc. TRYX Neuro Absorbable Antibacterial Envelope
Product Usage:
Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD) Terminated |
FTL | K063091 |
| Jun 29, 2016 | TYRX Inc. TRYX Absorbable Antibacterial Envelope
Product Usage:
Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD) Terminated |
FTL | K063091 |
| Jun 29, 2016 | TYRX Inc. TRYX Antibacterial Envelope Rx Only
Product Usage:
Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD) Terminated |
FTL | K063091 |