Tyrx, Inc.
Monmouth Junction, NJ, US
Tyrx, Inc. appears in FDA device records in Monmouth Junction, NJ. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Tyrx, Inc. between 2010 and 2015. The busiest year on record is 2013, with 3. The most recent is 2015, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2013 | 3 |
| 2015 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K152678 | TYRX Neuro Antibacterial Envelope | FTL | Substantially Equivalent | |
| K132699 | AIGIS RX N (MEDIUM), AIGIS RX N (LARGE) | FTL | Substantially Equivalent | |
| K131007 | AIGIS RX N MEDIUM; AIGIS RX N LARGE | FTL | Substantially Equivalent | |
| K130943 | AIGIS RX R PM/ AIGIS RX R ICD | FTL | Substantially Equivalent | |
| K093524 | PIVIT A/B ST AND PIVIT A/B ST-R | FTL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
These records are listed because FDA’s enforcement report for the recall names this company, while the recall record itself carries the recalling firm under another name.
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2541-2016 | TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD) | TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated. | Class II | Terminated | |
| Z-2540-2016 | TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD) | TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated. | Class II | Terminated | |
| Z-2539-2016 | TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD) | TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain