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Glean
Bright Uro, Inc · Model GUS-1000-M · UDI-DI 00860009800601
8
510(k) clearances
9
Adverse events
1
Recalls
15
Facilities
Description
Glean Sensor with Male Insertion Tool 5 Pack
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2009-04-09 | Laborie Medical Technologies Cor | Laborie Medical Technologies reports that there was a mix up in the labeling and packaging of their Urodynamic Catheters. There were 8Fr catheters mixed inside the 6Fr catheter pac |
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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.