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Labware, Assisted Reproduction

FDA product code MQK · Class 2 · Obstetrics/Gynecology

212
Registered devices
2
Adverse events
4
Recalls
50
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2022-04-01CooperSurgical, Inc.Products in this lot may have compromised barrier seals, introducing a risk to sterility.
2014-06-20ORIGIO, IncIdentification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration
2011-11-28ORIGIO HUMAGEN PIPETS INC.Cryopettes were rupturing during the warming process following vitrification.
2007-05-08Humagen Fertility Diagnostics, Inc.Pasteur pipettes for laboratory use were labeled as sterile but may have become contaminated.

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