Neomedix Corp.
San Juan Capistrano, CA, US
Neomedix Corp. appears in FDA device records in San Juan Capistrano, CA. FDA records list 4 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Neomedix Corp. between 2003 and 2006. The busiest year on record is 2004, with 2. The most recent is 2006, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2004 | 2 |
| 2006 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K061258 | TRABECTOME HIGH FREQUENCY GENERATOR/LP | GEI | Substantially Equivalent | |
| K040584 | NMX-1000 | GEI | Substantially Equivalent | |
| K040239 | SUPRAFLOW CONSOLE | BTA | Substantially Equivalent | |
| K024304 | MICROSURGICAL BIPOLAR HANDPIECE | GEI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0071-2008 | NeoMedix Trabectome I/A Console, Model Number 550014, surgical aspirator | Failure of irrigation flow: The pinch valve in a few pumps may not consistently open to allow irrigation flow. In over 450 surgeries, the firm confirmed one instance of a valve that did not open. The electrically activated pinch valve in the NeoMedix Trabectome I/A pump activates irrigation flow to the eye during Trabectome surgery. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain