510(k) Report

FDA applicant

Blue Torch Medical Technologies

Newton, MA2 decisions2003–20040 recalls

FDA records 2 decisions for Blue Torch Medical Technologies (Newton, MA) from 2003 to 2004: 2 510(k) clearances. All are in product code FGM (Probe And Director, Gastro-Urology). 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 Blue Torch Medical Technologies’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Blue Torch Medical Technologies since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Blue”

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