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Abbott Mfg., Inc.

United StatesFDA applicant, unverified

Devices
14

What Abbott Mfg., Inc. makes

Abbott Manufacturing, Inc. produces infusion pumps, including enteral and intravenous models like the Flexiflo Six Enteral Nutrition Pump and Abbott Lifecycle Standard Tubing Infusion Pump, as well as primary IV sets with integrated backcheck valves. The company also manufactures diagnostic reagents and analyzers, such as the Abbott iMx UltraSensitive HTSH and Abbott Prism Analyzer, used for hormone and biochemical testing, including prolactin, folate, and gentamicin assays. Additional products include extension sets for medical devices and specialized tubing for CO₂ monitoring.

These devices are classified under Class I and Class II regulatory categories in the U.S. and are listed via FDA 510(k) clearance, demonstrating compliance with U.S. medical device regulations. The company operates under U.S. jurisdiction, adhering to domestic regulatory requirements for manufacturing and distribution.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue14

Newest first, rows 1-14 of 14

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  • Lifeshield Extension Set Ref K941214

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Imx Ultrasentitive Htsh Ref K902753

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Abbott Imx Prolactin(Modification) Ref K953656

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Ca Ref K981232

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Imx Folate Ref K943691

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Albp Ref K981457

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Axsym Gentamicin Ref K935376

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Abbott Lifecare Standard Tubing Infusion Pump Ref K965230

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Abbott Prism Analyzer Ref K940289

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Lifeshield Primary I.V. Set With Backcheck Valve Ref K971293

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • CO2 Ref K981231

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Flexiflo Six Enteral Nutrition Pump Ref K943733

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Abbott Axsym Prolactin(Modification) Ref K953657

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Flexiflo Quantum Enteral Pump Ref K944669

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-14 of 14

Frequently asked questions

How many devices does Abbott Mfg., Inc. have in the registry?

The registry currently lists 14 devices for Abbott Mfg., Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Abbott Mfg., Inc.'s devices?

Among its 14 most recently registered devices, Abbott Mfg., Inc. has devices listed in FDA 510(k) (14 devices).

What risk classes do Abbott Mfg., Inc.'s devices fall under?

Among its 14 most recently registered devices, the classes recorded for Abbott Mfg., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Abbott Mfg., Inc. in the registry?

The most recently registered devices listed for Abbott Mfg., Inc. include LIFESHIELD EXTENSION SET, IMX ULTRASENTITIVE HTSH, ABBOTT IMX PROLACTIN(MODIFICATION) and CA.

Generated automatically from registry data and not verified by a human reviewer.