510(k) Report

FDA applicant

Instrument AB Scanditronix

Walker, MI1 decision1982–19820 recalls

FDA records 1 decision for Instrument AB Scanditronix (Walker, MI) in 1982: 1 510(k) clearance. No recall is linked to its devices.

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

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

FDA decisions per year

No FDA decision for Instrument AB Scanditronix since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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What has FDA decided for it lately?

  • K827704MM-22 MicrotronInstrument AB Scanditronix · 1982

The one decision as Instrument AB Scanditronix →

Other applicant names beginning “Instrument”

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

Instrument Makar, Inc. 28Instrument Technology, Inc. 2Instrument Development Corp. 1