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Towako

WILLIAM A. COOK AUSTRALIA PTY. LTD. · Model G18742 · UDI-DI 00827002187429

MQF Prescription
1
510(k) clearances
166
Adverse events
36
Recalls
38
Facilities

Description

Transmyometrial, Embryo Transfer Set

Recalls

DateFirmReason
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.
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.
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.

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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.