Data / Medical devices / United States / Neomend, Inc.
Neomend, Inc.: FDA-registered device maker in Irvine, CA, United States, 2 PMA approvals
Neomend, Inc. is registered with the FDA (registration 2953195) in Irvine, CA, United States. It lists 1 device type. The FDA files 2 PMA approvals under its listings, the newest dated April 11, 2016. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2953195
- FEI number
- 3001237235
- Address
- 60 Technology Dr, Irvine, CA, United States, 92618
- Owner or operator
- Neomend, Inc. (9030025)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- February 3, 2010
- Registered through
- 2027
- Brand names listed
- Progel, Tridyne
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sealant, Polymerizing | NBE | 3 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 11, 2016 | P150016 | TRIDYNE VASCULAR SEALANT | NBE | 27 | March 12, 2026 | accessdata.fda.gov |
| January 14, 2010 | P010047 | PROGEL PLEURAL AIR LEAK SEALANT | NBE | 67 | March 12, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 13, 2012 | 63156 | Class II | Terminated | Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product Usage: The Progel Pleural Air Leak Sealant is indicated for application to visceral pleura during an open thoracotomy after standard visceral pl | Product was distributed with an incorrect expiration date. Product was labeled with an expiration date of 2013-04 and should have been labeled with 2012-09. | accessdata.fda.gov |
Compare with other makers
Updated March 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.