510(k) Report

FDA applicant

Retrax

Wausau, WI2 decisions1990–19930 recalls

FDA records 2 decisions for Retrax (Wausau, WI) from 1990 to 1993: 2 510(k) clearances. Most are in product codes FHQ (Holder, Needle, Gastroenterologic) and FMF (Syringe, Piston). No recall is linked to its devices.

FDA’s records also spell it “Retrax, Inc.”.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Retrax since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Retrax’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Retrax”

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