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

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

    NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF; PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1; PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, REF: NIM4CPB1RF; SOFTWARE NIM4SWU143 UPGRADE V1.4.3, REF: NIM4SWU143; SOFTWARE NIM4SWU154 UPGRADE V1.5.4, REF: NIM4SWU154; SOFTWARE NIM4SWU164 UPGRADE V1.6.4, REF: NIM4SWU164

    FDA Enforcement
    Class II ·Ongoing·Medtronic Xomed, Inc.·April 30, 2025

    NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2

    FDA Enforcement
    Class II ·Ongoing·Medtronic Xomed, Inc.·June 8, 2022

    NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2

    FDA Enforcement
    Class II ·Ongoing·Medtronic Xomed, Inc.·June 8, 2022

    GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·November 29, 2023

    GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·November 29, 2023

    NIM TRIVANTAGE EMG Endotracheal Tube

    FDA Enforcement
    Class II ·Ongoing·Medtronic Xomed, Inc.·March 16, 2022

    GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360009

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·November 29, 2023

    NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 8229708, 8.0MM ID; d) 8229736, 6MM ID 3PK; e) 8229737, 7MM ID 3 PK; f) 8229738, 8MM ID 3 PK

    FDA Enforcement
    Class II ·Ongoing·Medtronic Xomed, Inc.·January 17, 2024