BEUDAMED
    7 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN4130/L IN4130/T IN4230/JPH IN4230/K IN4330/CNK IN4330/K IN4352/K IN4430/K IN4530/CNK IN4530/K IN4530/T IN4802/K IN4802/T IN4852/K IN4901/A IN4902/A IN4903/A IN4904/A IN4905/A IN4906/A IN4907/A IN4908 IN4909 IN4910 IN4911/A IN4912 IN4913/A IN4914/A IN4915 IN4916/A IN4917/A IN4918/A IN4919/A

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·January 28, 2026

    GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems Information Technologies Inc·June 3, 2026

    GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems Information Technologies Inc·June 3, 2026

    CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Mishima K.K.·March 18, 2026

    DxC 700 AU, REF: B86444, B86446

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Mishima K.K.·March 18, 2026

    DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Mishima K.K.·August 7, 2024

    DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Mishima K.K.·August 28, 2024