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Soft-Pass
COOK INCORPORATED · Model G19084 · UDI-DI 00827002190849
MQF
Prescription
10
510(k) clearances
164
Adverse events
36
Recalls
38
Facilities
Description
Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-12-23 | Tenderneeds Fertility LLC | Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021. |
| 2020-12-23 | Tenderneeds Fertility LLC | Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021. |
| 2020-12-23 | Tenderneeds Fertility LLC | Device was distributed without a proper marketing authorization. |
| 2020-12-23 | Tenderneeds Fertility LLC | Device was distributed without a proper marketing authorization. |
| 2020-12-23 | Tenderneeds Fertility LLC | Device was distributed without a proper marketing authorization. |
| 2020-12-23 | Tenderneeds Fertility LLC | Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021. |
| 2020-12-23 | Tenderneeds Fertility LLC | Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021. |
| 2020-12-23 | Tenderneeds Fertility LLC | Device was distributed without a proper marketing authorization. |
| 2020-12-23 | Tenderneeds Fertility LLC | Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021. |
| 2020-12-23 | Tenderneeds Fertility LLC | Device was distributed without a proper marketing authorization. |
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Get your free API keyRead the docsData 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.