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Solyx™ SIS System
BOSTON SCIENTIFIC CORPORATION · Model M0068507000 · UDI-DI 08714729774044
PAH
Prescription
10
510(k) clearances
5,966
Adverse events (100 deaths)
1
Recalls
15
Facilities
Description
SIS System
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-10-26 | Astora | The lot number on the outer carton label did not match the lot number printed on the tray label or identification labels inside the box. The identification labels inside the box a |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.
