FDA applicant

Promex, Inc.

Indianapolis, IN18 decisions1994–200214 recalls

FDA records 18 decisions for Promex, Inc. (Indianapolis, IN) from 1994 to 2002: 18 510(k) clearances. Most are in product codes KNW (Instrument, Biopsy) and FCG (Biopsy Needle). 14 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Promex, Inc. since 2007.

Recalls per year

6in 2020

2007high 6 (2020) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Promex, 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 “Promex”

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

Promex Technologies, LLC 1

Promex, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Promex”