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EchoGen Spherical O

Origio A/S · Model TSET24SASOEG · UDI-DI 20888937972379

MQF Prescription
1
510(k) clearances
168
Adverse events
36
Recalls
38
Facilities

Description

Embryo transfer catheter, echogenic, spherical, with obturator

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.
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.
2020-12-23Tenderneeds Fertility LLCDevice was distributed without a proper marketing authorization.
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.