FDA-Device2021-04-14Class II
At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903)
Tenderneeds Fertility LLC
Hazard
Device was distributed without a proper marketing authorization.
Sold states
World-wide distribution.
Affected count
Unknown
Manufactured in
10162 Bradford Rd, N/A, Greenville, IN, United States
Products
At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1356-2021Don't want to check this manually?
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