510(k) Report

FDA applicant

Synectics-Dantec

Irving, TX19 decisions1985–19970 recalls

FDA records 19 decisions for Synectics-Dantec (Irving, TX) from 1985 to 1997: 19 510(k) clearances. Most are in product codes FFT (Electrode, Ph, Stomach) and FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic…). No recall is linked to its devices.

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 Synectics-Dantec’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Synectics-Dantec since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Synectics-Dantec”

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