FDA applicant

Bergen Mfg.

New Port Richey, FL4 decisions1986–19970 recalls

FDA records 4 decisions for Bergen Mfg. (New Port Richey, FL) from 1986 to 1997: 4 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and HAM (Apparatus, Electrosurgical). Its devices cite 2 predicates, 2 of them its own earlier devices. 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Bergen Mfg. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bergen Mfg.’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 “Bergen”

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

Bergen Medical Products, Inc. 1

Bergen Mfg.

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?

Other applicant names beginning “Bergen”