BEUDAMED
    22 results · 26ms · Sources: EU EUDAMED, US FDA

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    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

    AUTO REF/KERATOMETER ARK-1s

    FDA Enforcement
    Class II ·Terminated·Nidek Inc.·April 18, 2018

    Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·July 9, 2014

    IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System and Si-e. Intuitive Surgical Endoscopic Instrument Control System.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·July 9, 2014

    Vision Troubleshooting Guide for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·July 9, 2014

    Stapler Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·July 9, 2014

    Connection QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·July 9, 2014

    Vessel Sealer QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·July 9, 2014

    Cautery QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·July 9, 2014

    Vessel Sealer Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·July 9, 2014

    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

    Natural Rubber Latex QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·July 9, 2014

    Endowrist Instrument and Accessory Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·July 9, 2014

    System Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·July 9, 2014

    Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·July 9, 2014

    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

    Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670

    FDA Enforcement
    Class II ·Completed·Beckman Coulter Mishima K.K.·June 11, 2025

    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