FDA-Device2019-11-20Class II
EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
Monarch Medical Technologies
Hazard
Product was distributed prior to approval or clearance from FDA.
Sold states
SC, IL IN, CA
Affected count
6 units
Manufactured in
2137 South Blvd Ste 300, N/A, Charlotte, NC, United States
Products
EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0354-2020Don't want to check this manually?
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