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Catheter, Assisted Reproduction

FDA product code MQF · Class 2 · Obstetrics/Gynecology

319
Registered devices
168
Adverse events
36
Recalls
53
510(k) clearances

Devices with this code

Guardia — COOK INCORPORATEDMinvitro Embryo Transfer Catheter — Guangzhou Hehong Biotech Co., Ltd.Wallace — ICU MEDICAL, INC.MedGyn IUI catheter — MedGyn Products, Inc.Wallace — ICU MEDICAL, INC.ET CATHETER RYDEN — KITAZATO CORPORATIONWallace Trial Transfer Catheter — Coopersurgical, Inc.Kitazato IUI Catheter — KITAZATO CORPORATIONKitazato ET Catheter — KITAZATO CORPORATIONKitazato ET Catheter — KITAZATO CORPORATIONWallace — ICU MEDICAL, INC.Tefcat — COOK INCORPORATEDEvie — FERTILIGENT LTDFRYDMAN® ULTRASOFT — LABORATOIRE CCDEvie — FERTILIGENT LTDKitazato ET Catheter — KITAZATO CORPORATIONWallace Rigid Stylet for 18cm Catheter — Coopersurgical, Inc.Kitazato ET Catheter — KITAZATO CORPORATIONKitazato ET Catheter — KITAZATO CORPORATIONGuardia — COOK INCORPORATEDKitazato ET Catheter — KITAZATO CORPORATIONShepard — COOK INCORPORATEDKitazato IUI Catheter — KITAZATO CORPORATIONSoft embryo transfer catheter — Gynetics Medical Products NV

Recent 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.
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. 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.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.