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Data / Medical devices / Accessory, Assisted Reproduction

Accessory, Assisted Reproduction (MQG): 18 FDA-registered makers in 8 countries

18 establishments in 8 countries are registered with the FDA to make Accessory, Assisted Reproduction (product code MQG, Class 2, 21 CFR 884.6120). 15 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 47 510(k) clearances under this code, the latest on August 19, 2026, and lists 6 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
MQG
Device class
2
Regulation
884.6120
Medical specialty
Obstetrics/Gynecology

Makers by country

CountryMakers
United States7
China3
Australia2
United Kingdom2
Denmark1
Lithuania1
France1
Thailand1

Makers of Accessory, Assisted Reproduction

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Coopersurgical, Inc.Trumbull, CT, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer5August 19, 2026020api.fda.gov
Vitrolife A/SViby J Midtjylland, DenmarkManufacturer, Specification developer5May 11, 2018000api.fda.gov
William A. Cook Australia Pty, Ltd.EIGHT MILE PLAINS Queensland, AustraliaComplaint file establishment, Manufacturer4June 13, 2017000api.fda.gov
GENEA BIOMEDX Pty Ltd.Sydney New South Wales, AustraliaSpecification developer3June 7, 2018000api.fda.gov
Thermo Fisher Scientific (asheville) LLCMarietta, OH, United StatesComplaint file establishment, Manufacturer3May 15, 2002000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer2October 27, 1999020api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer2February 1, 1999000api.fda.gov
Esco Medical Technologies, UABRamuciai Kauno Apskritis, LithuaniaManufacturer2April 22, 2016000api.fda.gov
Cook IncorporatedEllettsville, IN, United StatesComplaint file establishment, Manufacturer1February 1, 1999000api.fda.gov
Cryo Bio SystemSaint Ouen sur Iton Orne, FranceManufacturer1November 17, 2000000api.fda.gov
Hua Yue Medical Technology Co., Ltd.Guangzhou Guangdong, ChinaManufacturer1May 22, 2025000api.fda.gov
LifeGlobal Group, LLCTrumbull, CT, United StatesSpecification developer1September 15, 2000000api.fda.gov
Rocket Medical PlcWASHINGTON Sunderland, United KingdomManufacturer, Repackager or relabeler1February 29, 2000000api.fda.gov
Research Instruments LtdFalmouth Cornwall, United KingdomContract manufacturer, Manufacturer1July 18, 2016000api.fda.gov
Wuhan Huchuang Union Technology Co., Ltd.Wuhan Hubei, ChinaExporter to the US, Manufacturer1May 7, 2024000api.fda.gov
Advanced Instrumentations, Inc.Miami, FL, United StatesSpecification developer0000api.fda.gov
Plexus (Thailand) Co., Ltd.Amphur Bang Pakong Chachoengsao, ThailandContract manufacturer0000api.fda.gov
Saint-Gobain Life Sciences (Hangzhou) Co., LtdHangzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov

Updated August 19, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.