Neomend, Inc.: FDA clearances and approvals
Neomend, Inc. has 0 FDA 510(k) clearances, plus 2 PMA decisions, across 1 product code in 1 review panel. openFDA lists 1 product recall by a recalling firm named Neomend, Inc.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NBE | Sealant, Polymerizing | 2 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P150016 | PMA | TRIDYNE VASCULAR SEALANT | 2016-04-11 |
| P010047 | PMA | PROGEL PLEURAL AIR LEAK SEALANT | 2010-01-14 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2012-08-13.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Neomend, Inc. have?
Neomend, Inc. has 0 FDA 510(k) clearances, plus 2 PMA decisions, across 1 product code in 1 review panel.
What devices does Neomend, Inc. make?
Its most frequent FDA product codes are NBE (Sealant, Polymerizing, 2).
Has Neomend, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Neomend, Inc; the most recent began 2012-08-13. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 0 Neomend, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NBE, Neomend, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.