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Flo-X
MINIMALLY INVASIVE DEVICES, INC. · Model FX10 · UDI-DI 00815128020652
OCT
Prescription
10
510(k) clearances
182
Adverse events
2
Recalls
61
Facilities
Description
The Defogging and Cleaning Solution is a single-use laparoscopic accessory device intended to facilitate intra-operative defogging and cleaning of the lens of a laparoscope during minimally invasive surgery while maintaining visualization of the surgical site.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-01-14 | Sunstar Americas, Inc. | Product lacks premarket clearance. |
| 2019-05-30 | Medline Industries, Inc. | The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties. |
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