FDA applicant

Sterilmed Inc. (Johnson and Johnson)

Plymouth, MN1 decision2021–20210 recalls

FDA records 1 decision for Sterilmed Inc. (Johnson and Johnson) (Plymouth, MN) in 2021: 1 510(k) clearance. All are in product code MTD (Catheter, Intracardiac Mapping, High-Density…). Its devices cite 1 predicate, 0 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, cardiovascular panel, where it files most

How often FDA has decided Sterilmed Inc. (Johnson and Johnson)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Sterilmed Inc. (Johnson and Johnson) by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sterilmed Inc. (Johnson and Johnson)’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 “Sterilmed”

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

Sterilmed, Inc. 65

Sterilmed Inc. (Johnson and Johnson)

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Sterilmed”