Biologic Therapies, Inc
Medical device manufacturer in Prior Lake, MN.
1510(k) clearances
0PMA approvals
3recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K141910 | Intraosseous Cannula System Bio-MAC¿ and Bio-COREKNW · Traditional | 05/04/2015SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1374-2015 Class II | Bio-CORE Cannula (Needle) SetDevices are misbranded - failure to properly classify and obtain FDA clearance prior distribution | 01/23/2015Terminated |
| Z-1373-2015 Class II | Bio-MAC Cannula (Needle) SetDevices are misbranded - failure to properly classify and obtain FDA clearance prior distribution | 01/23/2015Terminated |
| Z-1372-2015 Class II | Bio-PLASTY Cannula (Needle)Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution | 01/23/2015Terminated |