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FloShield/Plus
MINIMALLY INVASIVE DEVICES, INC. · Model FSB-04-1045 · UDI-DI 00815128020591
10
510(k) clearances
182
Adverse events
2
Recalls
62
Facilities
Description
The FloShield/Plus System is a single-use, disposable 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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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.