Bwxt Medical Ltd.
OTTAWA Ontario, CA
BWXT MEDICAL LTD. appears in FDA device records in OTTAWA Ontario, CA. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Bwxt Medical Ltd. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- MDS Canada Inc. DBA MDS Nordionrecall
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 |
|---|---|---|---|---|---|
| 8022247 | 3001092088 | BWXT MEDICAL LTD. | 447 MARCH RD., OTTAWA Ontario K2K1X8 CA | 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-1325-2009 | TheraSphere Administration Set (Part Number K125914-034). TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable Hepatocellular carcinoma(HCC) who can have placement of appropriately positioned hepatic arterial catheters. The device is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion. | Instructions for the use of the pinch clamp that is an integral part of the TheraSphere Administration Set were not included with the distribution of the device. | Terminated | ||
| Z-1184-06 | Theratron Elite 100 Cobalt Radiotherapy | The source locking device may not fit properly through the smaller opening in the new field light shield which could prevent the source from being returned manually under emergency conditions. | Terminated | ||
| Z-1183-06 | Theratron Elite 80 Cobalt Radiotherapy | The source locking device may not fit properly through the smaller opening in the new field light shield which could prevent the source from being returned manually under emergency conditions. | Terminated | ||
| Z-1182-06 | Theratron Phoenix Cobalt Radiotherapy | The source locking device may not fit properly through the smaller opening in the new field light shield which could prevent the source from being returned manually under emergency conditions. | Terminated | ||
| Z-1181-06 | Theratron 1000E Cobalt Radiotherapy | The source locking device may not fit properly through the smaller opening in the new field light shield which could prevent the source from being returned manually under emergency conditions. | Terminated | ||
| Z-1180-06 | Theratron 1000 Cobalt Radiotherapy | The source locking device may not fit properly through the smaller opening in the new field light shield which could prevent the source from being returned manually under emergency conditions. | Terminated | ||
| Z-1179-06 | Theratron 780E Cobalt Radiotherapy | The source locking device may not fit properly through the smaller opening in the new field light shield which could prevent the source from being returned manually under emergency conditions. | Terminated | ||
| Z-1178-06 | Theratron 780C Cobalt Radiotherapy | The source locking device may not fit properly through the smaller opening in the new field light shield which could prevent the source from being returned manually under emergency conditions. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain