Visualase Neuro Accessories
FHC, INC. · Model 9736536-00931 · UDI-DI 00873263009314
7
510(k) clearances
37
Adverse events
3
Recalls
97
Facilities
Description
Visualase Neuro Accessories (1) Anchor Bolt (1) Stiffening Stylet (1) Anchor Bolt Removal Tool
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-04-01 | CLINICAL LASERTHERMIA SYSTEMS AB | single use devices labeled as sterile may not have been adequately sterilized |
| 2016-09-01 | Medtronic Navigation, Inc. | Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Stylets and Visualase Body Accessory Kit because when the Visualization Stylet is plac |
| 2016-09-01 | Medtronic Navigation, Inc. | Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Stylets and Visualase Body Accessory Kit because when the Visualization Stylet is plac |
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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.