FDA applicant

Auris Health, Inc., part of Johnson & Johnson MedTech

Santa Clara, CA1 decision2026–20260 recalls

FDA records 1 decision for Auris Health, Inc., part of Johnson & Johnson MedTech (Santa Clara, CA) in 2026: 1 De Novo grant. All are in product code SIR (Integrated Operating Table-Electromechanical…). 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 Auris Health, Inc., part of Johnson & Johnson MedTech’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

FIG. 1 — Auris Health, Inc., part of Johnson & Johnson MedTech by year, 2026–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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See the 510(k) Report

Other applicant names beginning “Auris”

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

Auris Health, Inc. 5 Auris Health, Inc., A Johnson and Johnson Family Company 2 Auris Surgical Robotics, Inc. 2

Auris Health, Inc., part of Johnson & Johnson MedTech

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Auris”