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

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    ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150

    FDA Enforcement
    Class I ·Completed·ResMed Ltd.·February 12, 2020

    ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150

    FDA Recall
    Completed ·Product code MNT·December 12, 2019

    Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive

    FDA Enforcement
    Class II ·Completed·Withings Sas·August 22, 2018

    Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive

    FDA Recall
    Completed ·Withings Sas 2 rue Maurice Hartmann Issy les Moulineaux France·Product code DXN·June 11, 2018

    SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024

    AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222

    FDA Enforcement
    Class II ·Completed·Applied Medical Technology Inc·January 15, 2025

    SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX

    FDA Recall
    Completed ·Townsend Design·Product code IQI·September 23, 2023

    greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003

    FDA Enforcement
    Class II ·Completed·Greiner Bio-One North America, Inc.·May 24, 2023

    A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution, and delivering the sample to the cartridge.

    FDA Enforcement
    Class II ·Completed·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·October 30, 2024

    ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

    FDA Enforcement
    Class II ·Completed·Implant Direct Sybron Manufacturing, LLC·January 15, 2020

    ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

    FDA Enforcement
    Class II ·Completed·Implant Direct Sybron Manufacturing, LLC·January 15, 2020

    greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003

    FDA Recall
    Completed ·Greiner Bio-One North America, Inc.·Product code JKA·March 31, 2023

    ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

    FDA Recall
    Completed ·Implant Direct Sybron Manufacturing, LLC·Product code NDP·November 28, 2018

    ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

    FDA Recall
    Completed ·Implant Direct Sybron Manufacturing, LLC·Product code NDP·November 28, 2018

    NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR readers

    FDA Enforcement
    Class II ·Completed·Landauer·September 20, 2023

    Reader, nanoDot adapter, EU Model Number VINLADA003; radiation monitoring dosimeter used with the microSTAR readers

    FDA Enforcement
    Class II ·Completed·Landauer·September 20, 2023

    QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitoring dosimeter used with the microSTAR readers

    FDA Enforcement
    Class II ·Completed·Landauer·September 20, 2023

    QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitoring dosimeter used with the microSTAR readers

    FDA Enforcement
    Class II ·Completed·Landauer·September 20, 2023

    nanoDot D2DNN , Model Numbers: a) 04293-000; b) 04293-KIT; radiation monitoring dosimeter used with the microSTAR readers

    FDA Enforcement
    Class II ·Completed·Landauer·September 20, 2023

    Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 03065-OTO; radiation monitoring dosimeter used with the microSTAR readers

    FDA Enforcement
    Class II ·Completed·Landauer·September 20, 2023