Unilife Medical Solutions Limited
Sydney, Nsw, AU
Unilife Medical Solutions Limited appears in FDA device records in Sydney, Nsw, AU. FDA records list 3 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 3
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 3 510(k) clearances for Unilife Medical Solutions Limited between 2008 and 2010. The busiest year on record is 2010, with 2. The most recent is 2010, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2010 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K100998 | 1ML UNITRACT 27G X 1/2 TUBERCULIN SYRINGE, MODEL 132BY2-1 | MEG | Substantially Equivalent | |
| K093400 | 1ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/2 | FMF | Substantially Equivalent | |
| K080877 | 1ML UNITRACT INSULIN SYRINGE 27G*1/2 , 1ML UNITRACT SYRINGE 29G*1/2 | MEG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain