Claria Medical, Inc.: FDA filings under this applicant name

FDA lists 0 510(k) clearances under the applicant name “Claria Medical, 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

Review panels

• Obstetrics and Gynecology (1)

PMA and De Novo decisions

Recalls

openFDA lists no recalls under a recalling firm named Claria Medical, 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.

Frequently asked questions

How many FDA 510(k) clearances are listed under Claria Medical, Inc.?

FDA lists 0 510(k) clearances under the applicant name “Claria Medical, 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 Claria Medical, Inc.?

The most frequent FDA product codes under this applicant name are SIM (Gynecologic Power Morcellator And Containment System, 1).

Next steps

• See all 0 Claria Medical, Inc. clearances with predicates and recalls
• Run predicate analysis for product code SIM, Claria Medical, 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.

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