Sirtex Medical Inc.
Woburn, MA, US
SIRTEX MEDICAL INC. appears in FDA device records in Woburn, MA. FDA records list no 510(k) clearances, 24 PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012690638 | 3012690638 | SIRTEX MEDICAL INC. | 300 Unicorn Park Dr., 2nd Fl.,, Woburn, MA 01801 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1275-2021 | SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use. | There is a potential presence of particulate matter in the D-Vial. | Class II | Terminated | |
| Z-1162-2013 | Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors. | Incorrect expiration date | Class III | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain