Auris Health, Inc., part of Johnson & Johnson MedTech: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Auris Health, Inc., part of Johnson & Johnson MedTech”, plus 1 De Novo decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Johnson & Johnson MedTech, based on public ownership records.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SIR | Integrated Operating Table-Electromechanical Surgical System | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN250068 | De Novo | Integrated Operating Table-Electromechanical Surgical System | 2026-07-21 |
Recalls
openFDA lists no recalls under a recalling firm named Auris Health, Inc., part of Johnson & Johnson MedTech.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Auris Health, Inc. (5 510(k)s)
- Auris Health, Inc., A Johnson and Johnson Family Company (2 510(k)s)
- Auris Surgical Robotics, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Auris Health, Inc., part of Johnson & Johnson MedTech?
FDA lists 0 510(k) clearances under the applicant name “Auris Health, Inc., part of Johnson & Johnson MedTech”, plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Auris Health, Inc., part of Johnson & Johnson MedTech?
The most frequent FDA product codes under this applicant name are SIR (Integrated Operating Table-Electromechanical Surgical System, 1).
Next steps
- See all 0 Auris Health, Inc., part of Johnson & Johnson MedTech clearances with predicates and recalls
- Run predicate analysis for product code SIR, Auris Health, Inc., part of Johnson & Johnson MedTech's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.