FDA applicant

Jerome Medical

Mt Laurel, NJ9 decisions1982–20058 recalls

FDA records 9 decisions for Jerome Medical (Mt Laurel, NJ) from 1982 to 2005: 9 510(k) clearances. Most are in product codes JEC (Component, Traction, Invasive) and HAX (Tong, Skull For Traction). Its devices cite 1 predicate, 0 of them its own earlier devices. 8 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, orthopedic panel, where it files most

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

FDA decisions per year

No FDA decision for Jerome Medical since 2007.

Recalls per year

5in 2018

2007high 5 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

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

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Other applicant names beginning “Jerome”

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

The Jerome Group, Inc. 2 Jerome Instrument Corp. 1 Jerome M. Simon 1

Jerome Medical

Which product codes does it file in?

Whose devices does it build on?

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 “Jerome”