FDA applicant

Holter-Hausner Intl.

Bridgeport, PA42 decisions1978–19886 recalls

FDA records 42 decisions for Holter-Hausner Intl. (Bridgeport, PA) from 1978 to 1988: 42 510(k) clearances. Most are in product codes JXG (Shunt, Central Nervous System And Components) and HXA (Prosthesis, Tendon, Passive). 6 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, neurology panel, where it files most

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

FDA decisions per year

No FDA decision for Holter-Hausner Intl. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Holter-Hausner Intl. 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-Hausner”

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

Holter Data Services 1 Holter Recorders 1

Holter-Hausner Intl.

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 “Holter-Hausner”