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ORISE™ Gel
BOSTON SCIENTIFIC CORPORATION · Model M00519200 · UDI-DI 08714729974567
PLL
Prescription
9
510(k) clearances
70
Adverse events
1
Recalls
13
Facilities
Description
Submucosal Lifting Agent
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-10-10 | Boston Scientific Corporation | ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORl |
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