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Intrauterine insemination cannula

Gynetics Medical Products NV · Model #4220 IUI Memo · UDI-DI 05425017502012

MQF Prescription
1
510(k) clearances
164
Adverse events
36
Recalls
38
Facilities

Description

Intra uterine Artificial Insemination

Recalls

DateFirmReason
2020-12-23Tenderneeds Fertility LLCDevice was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
2020-12-23Tenderneeds Fertility LLCDevice was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
2020-12-23Tenderneeds Fertility LLCDevice was distributed without a proper marketing authorization.
2020-12-23Tenderneeds Fertility LLCDevice was distributed without a proper marketing authorization.
2020-12-23Tenderneeds Fertility LLCDevice was distributed without a proper marketing authorization.
2020-12-23Tenderneeds Fertility LLCDevice was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
2020-12-23Tenderneeds Fertility LLCDevice was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
2020-12-23Tenderneeds Fertility LLCDevice was distributed without a proper marketing authorization.
2020-12-23Tenderneeds Fertility LLCDevice was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
2020-12-23Tenderneeds Fertility LLCDevice was distributed without a proper marketing authorization.

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Data 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.