FDA Device Intelligence
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Catheter, Assisted Reproduction

FDA product code MQF · Class 2 · Obstetrics/Gynecology

319
Registered devices
164
Adverse events
36
Recalls
53
510(k) clearances

Devices with this code

Kitazato ET Catheter — KITAZATO CORPORATIONSoft embryo transfer catheter — Gynetics Medical Products NVSoft-Trans — COOK INCORPORATEDKitazato IUI Catheter without Stainless Steel Center Core Type1-v2 — KITAZATO CORPORATIONVitaVitro — SHENZHEN VITAVITRO BIOTECH CO.,LTD.ULTRASOFT FRYDMAN ® SET ECHO WITH GUIDE — LABORATOIRE CCDSoft-Trans — COOK INCORPORATEDSydney IVF — COOK INCORPORATEDEmbryo transfer catheter — Gynetics Medical Products NVKitazato ET Catheter — KITAZATO CORPORATIONSoft-Pass — COOK INCORPORATEDWallace Embryo Replacement Catheter — Coopersurgical, Inc.Kitazato IUI Catheter — KITAZATO CORPORATIONWallace — ICU MEDICAL, INC.Kitazato ET Catheter — KITAZATO CORPORATIONECHOGYN® EMBRYOVIEW M MOCK 23 CM — LABORATOIRE CCDSoft-Pass — COOK INCORPORATEDGuardia — COOK INCORPORATEDKitazato ET Catheter Type2-v6 EC-PRO Supported — KITAZATO CORPORATIONSoft Obturator for Twinkle Pro Embryo Trans — ALLWIN MEDICAL DEVICES, INC.Guardia — COOK INCORPORATEDTefcat — COOK INCORPORATEDSoft-Pass — COOK INCORPORATEDKitazato ET Catheter — KITAZATO CORPORATION

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.
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.

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