FDA applicant

Healthdyne Technologies, Inc.

Marietta, GA9 decisions1994–19991 recall

FDA records 9 decisions for Healthdyne Technologies, Inc. (Marietta, GA) from 1994 to 1999: 9 510(k) clearances. Most are in product codes BZD (Ventilator, Non-Continuous (Respirator)) and BYJ (Unit, Liquid-Oxygen, Portable). Its devices cite 1 predicate, 1 of them its own earlier devices. 1 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Healthdyne Technologies, Inc. since 2007.

Recalls per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Healthdyne Technologies, 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 “Healthdyne”

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

Healthdyne, Inc. 35 Healthdyne Cardiovascular, Inc. 5

Healthdyne Technologies, 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 “Healthdyne”