FDA applicant

Harold W. Berger Co.

Murrieta, CA1 decision1988–19880 recalls

FDA records 1 decision for Harold W. Berger Co. (Murrieta, CA) in 1988: 1 510(k) clearance. All are in product code HDY (Dilator, Cervical, Hygroscopic-Laminaria). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Harold W. Berger Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Harold W. Berger Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Harold W. Berger Co.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Harold”

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

Harold J. Kosasky, M.D. 1

Harold W. Berger Co.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Harold”