Tangible Science, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Tangible Science, Inc.”, 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 |
|---|---|---|---|
| QMM | Hydrophilic Re-Coating Solution | 1 | 0 |
Review panels
- Ophthalmic (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN200002 | De Novo | Hydrophilic Re-Coating Solution | 2020-09-24 |
Recalls
openFDA lists no recalls under a recalling firm named Tangible Science, Inc..
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 Tangible Science, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03417505: Tangible Hydra-PEG: A Promising Solution for Scleral Lens Wearers With Dry Eye (Completed, started 2018-01-30)
- NCT03073148: Evaluation of Tangible Boost Replenishing System (Completed, started 2017-02-24)
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.
- Tangible Science, LLC (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tangible Science, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Tangible Science, Inc.”, 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 Tangible Science, Inc.?
The most frequent FDA product codes under this applicant name are QMM (Hydrophilic Re-Coating Solution, 1).
Next steps
- See all 0 Tangible Science, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QMM, Tangible Science, Inc.'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.