510(k) Report

FDA applicant

Tyrx Pharma, Inc.

Monmouth Junction, NJ3 decisions2005–20083 recalls

FDA records 3 decisions for Tyrx Pharma, Inc. (Monmouth Junction, NJ) from 2005 to 2008: 3 510(k) clearances. All are in product code FTL (Mesh, Surgical, Polymeric). Its devices cite 8 predicates, 2 of them its own earlier devices. 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Tyrx Pharma, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

3in 2016

2016: 3
2007high 3 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Tyrx Pharma, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Tyrx”

FDA records each applicant name separately; these may or may not be the same firm.