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M-Flex®
DIVERSATEK HEALTHCARE, INC. · Model 1206-20 · UDI-DI 00816734020005
FAT
Prescription
8
510(k) clearances
36
Adverse events
2
Recalls
9
Facilities
Description
Blue Silicone Tungsten Maloney Esophageal Dilator, 20 French
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-05-11 | Stryker Endoscopy | The silicone sheath component of the product detaches from the catheter upon removal of the e-kit from the body. |
| 2009-08-20 | Stryker Endoscopy | The silicone sheath component of the product detaches from the catheter during removal of the e-kit from the body. |
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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.