FDA applicant

Holter Recorders

Corona, CA1 decision1986–19860 recalls

FDA records 1 decision for Holter Recorders (Corona, CA) in 1986: 1 510(k) clearance. All are in product code DSH (Recorder, Magnetic Tape, Medical). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Holter Recorders since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Holter”

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

Holter-Hausner Intl. 42 Holter Data Services 1

Holter Recorders

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Holter”