Tenderneeds Fertility LLC
Greenville, IN, US
Tenderneeds Fertility LLC appears in FDA device records in Greenville, IN. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 19 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 19
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2183-2021 | 2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknown | Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021. | Class II | Open, Classified | |
| Z-2182-2021 | Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046 | Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021. | Class II | Open, Classified | |
| Z-2181-2021 | Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856 | Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021. | Class II | Open, Classified | |
| Z-2180-2021 | TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771 | Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021. | Class II | Open, Classified | |
| Z-2179-2021 | 2 X Sterile Human Home Artificial Insemination Semen Kit (Human), SKU 143298592960 | Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021. | Class II | Open, Classified | |
| Z-2178-2021 | Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW | Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021. | Class II | Open, Classified | |
| Z-2177-2021 | Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, SKU 636391205887 | Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021. | Class II | Open, Classified | |
| Z-2176-2021 | Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt | Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021. | Class II | Open, Classified | |
| Z-2175-2021 | Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001 | Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021. | Class II | Open, Classified | |
| Z-1364-2021 | Professional At Home Artificial Intrauterine Insemination Set (SKU 644042787811) | Device was distributed without a proper marketing authorization. | Class II | Open, Classified | |
| Z-1363-2021 | Pro Series Fertility Device (SKU 644042788139) | Device was distributed without a proper marketing authorization. | Class II | Open, Classified | |
| Z-1362-2021 | Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013) | Device was distributed without a proper marketing authorization. | Class II | Open, Classified | |
| Z-1361-2021 | Professional Artificial Intrauterine Insemination Kit (SKU 636391205986) | Device was distributed without a proper marketing authorization. | Class II | Open, Classified | |
| Z-1360-2021 | Premium At Home Pro Series Insemination Kit (SKU 644042787927) | Device was distributed without a proper marketing authorization. | Class II | Open, Classified | |
| Z-1359-2021 | Deluxe At Home Artificial Insemination Kit (SKU 636391205832) | Device was distributed without a proper marketing authorization. | Class II | Open, Classified | |
| Z-1358-2021 | Deluxe At Home Pro Series Insemination Kit (SKU 644042787958) | Device was distributed without a proper marketing authorization. | Class II | Open, Classified | |
| Z-1357-2021 | At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870) | Device was distributed without a proper marketing authorization. | Class II | Open, Classified | |
| Z-1356-2021 | At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903) | Device was distributed without a proper marketing authorization. | Class II | Open, Classified | |
| Z-1355-2021 | At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801) | Device was distributed without a proper marketing authorization. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain