510(k) Report

FDA applicant

Medtech Instruments

Portland, OR2 decisions1989–19980 recalls

FDA records 2 decisions for Medtech Instruments (Portland, OR) from 1989 to 1998: 2 510(k) clearances. Most are in product codes HCS (Device, Temperature Measurement, Direct…) and ESW (Prosthesis, Esophageal). Its devices cite 2 predicates, 0 of them its own earlier devices. 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, neurology panel, where it files most

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

FDA decisions per year

No FDA decision for Medtech Instruments since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • HCSDevice, Temperature Measurement, Direct Contact, Powered1decision
  • ESWProsthesis, Esophageal1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K973584Medtronic Instent Esophacoil Esophageal Stent System and Esophacoil Extension SystemMedtech Instruments · 1998
  • K894772Thermalgraphic AnalyserMedtech Instruments · 1989

All 2 as Medtech Instruments →

Other applicant names beginning “Medtech”

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

Medtech Products, Inc. 14Medtech S.A 8Medtech Intl., Inc. 6Medtech S.A.S 4Medtech Industries, Inc. 4The Medtech Group, Inc. 2Medtech Systems, Inc. 1