FDA-Device2021-04-14Class II
At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801)
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 Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1355-2021Don't want to check this manually?
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