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Data / Medical devices / Injector, Contrast Medium, Automatic

Injector, Contrast Medium, Automatic (IZQ): 24 FDA-registered makers in 12 countries

24 establishments in 12 countries are registered with the FDA to make Injector, Contrast Medium, Automatic (product code IZQ, Class 2, 21 CFR 870.1650). 7 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 23 510(k) clearances under this code, the latest on August 3, 2026, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
IZQ
Device class
2
Regulation
870.1650
Medical specialty
Cardiovascular

Makers by country

CountryMakers
Germany6
United States6
Mexico2
Italy2
Switzerland1
Australia1
Costa Rica1
Morocco1
Ireland1
Tunisia1
Monaco1
China1

Makers of Injector, Contrast Medium, Automatic

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
Ulrich GMBH & Co. KGULM Baden-Wurttemberg, GermanyManufacturer7November 18, 2025000api.fda.gov
Acist Medical Systems, Inc.Eden Prairie, MN, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Specification developer4August 3, 2026000api.fda.gov
Bayer Medical Care Inc.Indianola, PA, United StatesComplaint file establishment, Manufacturer, Specification developer2November 5, 2024000api.fda.gov
Bracco Injeneering S.A.LAUSANNE Vaud, SwitzerlandManufacturer, Specification developer2April 13, 2007000api.fda.gov
Imaxeon Pty LtdRydalmere New South Wales, AustraliaSpecification developer2September 24, 2025000api.fda.gov
Liebel-Flarsheim Company LLCCincinnati, OH, United StatesManufacturer, Remanufacturer2January 14, 2016030api.fda.gov
Ulrich GMBH & Co. KGDornstadt Baden-Wurttemberg, GermanyManufacturer2November 18, 2025000api.fda.gov
Bytec Medizintechnik GMBHEschweiler North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Bayer Medical Care Inc.Pittsburgh, PA, United StatesContract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer0000api.fda.gov
Bayer Medical Care Inc.Saxonburg, PA, United StatesManufacturer0000api.fda.gov
Bayer Medical SRLBarreal de Heredia, Costa RicaContract manufacturer0000api.fda.gov
Border Assembly S de RL de CVTIJUANA Baja California, MexicoContract manufacturer0000api.fda.gov
Coeur, Inc.(a Wholly Owned Subsidiary Of Illinois Tool Works Inc.)Washington, NC, United StatesContract manufacturer0000api.fda.gov
EmotechnicCasablanca, MoroccoContract manufacturer0000api.fda.gov
Gerresheimer Regensburg GmbHWackersdorf Bavaria, GermanyContract manufacturer0000api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.APODACA Nuevo Leon, MexicoContract manufacturer0000api.fda.gov
Infumed GMBHFriedeburg Lower Saxony, GermanyContract manufacturer0000api.fda.gov
Lre Medical GMBHNOERDLINGEN Bavaria, GermanyContract manufacturer0000api.fda.gov
Medisize Ireland Ltd.LETTERKENNY Donegal, IrelandContract manufacturer0000api.fda.gov
PromedtechFouchena Tunis, TunisiaContract manufacturer0000api.fda.gov
Promepla S.A.MMONACO Monaco-Ville, MonacoContract manufacturer0000api.fda.gov
Sidam SRLMirandola Modena, ItalyContract manufacturer0000api.fda.gov
Sidam SRLMirandola Modena, ItalyContract manufacturer0000api.fda.gov
Vincent Medical (dong Guan) Manufacturing Co., Ltd.Dong Guan City Guangdong, ChinaContract manufacturer0000api.fda.gov

Updated August 3, 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.