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Mallinckrodt Critical Care

Country not established

Devices
92

What Mallinckrodt Critical Care makes

The company produces diagnostic reagents and monitoring devices, including glucose test kits (O-toluidine-based), radioimmunoassay (RIA) kits for thyroid hormones (T4) and C-peptide, and electrolyte test kits for sodium and potassium. It also manufactures medical-grade diluents, temperature monitoring tools like the Hi-Lo Temp Model 8700 patient monitor and myocardial temperature sensors, and specialized infusion kits for coronary procedures. Additional products include a foam nasal airway, bronchoscopy catheters, and thermocouple adaptors for temperature measurement.

The portfolio consists of Class I and Class II medical devices, with several products authorised via the FDA’s 510(k) pathway. These devices are listed under US regulatory requirements, and the company operates from the United States.

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

Catalogue92

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  • Inline Foam Nose Ref K840398

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

  • Ria-Quant Fpa Test Kit Ref K821151

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

  • Cholesterol Standards Ref K802823

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

  • Uncuffed Laser Resisteant Tracheal Tube(Tentative) Ref K862666

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

  • Uric Acid Test Kit Ref K770564

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

  • Spac Digoxin Kit Ref K760800

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

  • Combined Glucose And Bun Standards Ref K802825

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

  • Pediatric Double Swivel Connector Ref K812000

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

  • Angiographic Catheter (Cardiology & Radiology) Ref K861483

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

  • Luer Lock Adapter/Nut Ref K862653

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

  • Flucose U.V. Test Kit Ref K770844

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

  • Guiding Catheter Ref K873004

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

  • Disposable Manifold Set Ref K832657

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

  • Dri-Lyte Ref K780353

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

  • Spac Tm T3 Uptake Kit Ref K770033

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

  • Cardiovascular Spring Guide Wire Ref K834223

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

  • Hi-Lo Temp Esophageal Stethoscope Ref K811862

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

  • Combuned Calcium And Phosphorus Std. Ref K802824

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

  • Glucose Reagent (Hexohinase) Ref K771311

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

  • Spac T3 Ria Test Kit Ref K801125

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

  • Dispenser, Gas Xenon Ref K781107

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

  • Chloride Test Kit Ref K842011

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

  • Ferro-Quant Tm Fe 59 Test Kit Ref K800868

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

  • Lgt Tube Ref K852413

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

  • Foley-Temp Ref K831567

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

  • Uncuffed Reinforced Tracheal Tube Ref K841872

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

  • P.A.P. Ria Control Serum Pack Ref K790985

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

  • Tracheal Tube/Stethoscope Ref K842464

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

  • Lipase Test Kit Ref K792289

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

  • Percutaneous Angiographic Needles Ref K845037

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

  • Ria Quant B-Hcg Test Kit Ref K781578

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

  • Hi-Lo Temp Tympanic Temp. Sensor Ref K832635

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

  • Fem Cath (Urethral Catheter) Ref K761144

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

  • Lariat Catheter Ref K844598

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

  • Angiography Kit Ref K821976

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

  • Calcium Reagent Ref K771310

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

  • Spac T4 Ria Test Kit Ref K820725

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

  • Angiourography Kit Ref K822159

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

  • Magnesium Test Kit Ref K803088

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

  • Catheter, Arterial Embolectomy Ref K770714

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

  • Tracheal Tube W/Illuminating Locater Ref K830631

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

  • Cholesterol Reagent Ref K771313

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

Rows 51-92 of 92

Showing 51-92 of 92