Specialized Health Products, Inc.
Bountiful, UT, US
Specialized Health Products, Inc. appears in FDA device records in Bountiful, UT. 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 Specialized Health Products, Inc. between 1996 and 2005. The busiest year on record is 1996, with 1. The most recent is 2005, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 1997 | 1 |
| 2001 | 1 |
| 2005 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K050023 | SECURELOC; ADVANCINTRODUCER | DYB | Substantially Equivalent | |
| K013394 | LIFTLOC SAFETY INFUSION SET | FPA | Substantially Equivalent | |
| K964042 | EXTRESAFE PHLEBOTOMY | FMI | Substantially Equivalent | |
| K962149 | SAFETY CRADLE | FMI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0837-03 | SHPI LIftLoc Safety Infusion Sets | Pouch seals on Safety Infusion Sets may be defective, possibly compromising sterility. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain