Sensimed AG: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Sensimed AG”, 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.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PLZ | Ocular Pattern Recorder | 1 | 0 |
Review panels
- Ophthalmic (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN140017 | De Novo | Ocular Pattern Recorder | 2016-03-04 |
Recalls
openFDA lists no recalls under a recalling firm named Sensimed AG.
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.
Device clinical trials
An industry sponsor named Sensimed AG is the lead sponsor of 18 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT04024293: Intraocular Pressure Measured by a Novel Sensing Contact Lens Versus Tonometry (Recruiting, started 2025-10-01)
- NCT03689088: Sensing Contact Lens-based Device for 24-hour Monitoring of Intraocular Pressure (Completed, started 2018-05-22)
- NCT01972997: SENSIMED Triggerfish Sensor Sizes (Completed, started 2013-07)
- NCT01938287: SENSIMED Triggerfish in Closed Eyes (Completed, started 2013-07)
- NCT01906502: 24-hour IOP Pattern With SENSIMED Triggerfish® in a Healthy Population (Completed, started 2013-07)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sensimed AG?
FDA lists 0 510(k) clearances under the applicant name “Sensimed AG”, 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 Sensimed AG?
The most frequent FDA product codes under this applicant name are PLZ (Ocular Pattern Recorder, 1).
Next steps
- See all 0 Sensimed AG clearances with predicates and recalls
- Run predicate analysis for product code PLZ, Sensimed AG'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.