BEUDAMED
    17 results · 17ms · Sources: EU EUDAMED, US FDA

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

    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 Software: TKA 2.0.de.1+TKA 1.0.1.de.1+PKA3.0.2.de. Application Part Number: 700002190743-03

    FDA Enforcement
    Class II ·Ongoing·Stryker Orthopaedics·June 5, 2024

    Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (French language), DCF-E110SG-IT/1 (Italian language)

    FDA Enforcement
    Class II ·Ongoing·Defibtech, LLC·May 7, 2025

    KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000

    FDA Enforcement
    Class II ·Ongoing·Pro-Dex Inc·November 6, 2024

    KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.

    FDA Enforcement
    Class II ·Ongoing·Pro-Dex Inc·April 26, 2023

    KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver

    FDA Enforcement
    Class II ·Ongoing·Pro-Dex Inc·July 12, 2023

    Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723

    FDA Enforcement
    Class II ·Ongoing·Fisher & Paykel Healthcare, Ltd.·October 22, 2025

    Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;

    FDA Enforcement
    Class II ·Ongoing·Adept Medical Ltd·January 29, 2025

    Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;

    FDA Enforcement
    Class II ·Ongoing·Adept Medical Ltd·January 29, 2025

    PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities.

    FDA Enforcement
    Class II ·Ongoing·Fisher & Paykel Healthcare, Ltd.·October 2, 2024

    Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US

    FDA Enforcement
    Class II ·Ongoing·Fisher & Paykel Healthcare, Ltd.·May 22, 2024

    Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;

    FDA Enforcement
    Class II ·Ongoing·Adept Medical Ltd·January 29, 2025

    Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;

    FDA Enforcement
    Class II ·Ongoing·Adept Medical Ltd·January 29, 2025

    Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;

    FDA Enforcement
    Class II ·Ongoing·Adept Medical Ltd·January 29, 2025

    Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;

    FDA Enforcement
    Class II ·Ongoing·Adept Medical Ltd·January 29, 2025

    Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;

    FDA Enforcement
    Class II ·Ongoing·Adept Medical Ltd·January 29, 2025

    Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;

    FDA Enforcement
    Class II ·Ongoing·Adept Medical Ltd·January 29, 2025

    GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare GmbH·December 24, 2025