BEUDAMED
    18 results · 16ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-2020/60

    FDA Enforcement
    Class II ·Ongoing·Linkbio Corp.·May 10, 2023

    LINK SLED Knee System: ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2020/40

    FDA Enforcement
    Class II ·Ongoing·Linkbio Corp.·May 10, 2023

    LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2020/52

    FDA Enforcement
    Class II ·Ongoing·Linkbio Corp.·May 10, 2023

    1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance humification of ventilator-dependent and non-ventilator dependent patients in critical care, home care and anesthesia.

    FDA Enforcement
    Class II ·Terminated·AB ULAX·October 14, 2020

    LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2020/46

    FDA Enforcement
    Class II ·Ongoing·Linkbio Corp.·May 10, 2023

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020

    Kit BD Max Enteric Parasite Panel EU; Catalog # 442960

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·August 28, 2019

    Sterile Custom Packs to be used in surgical procedures.

    FDA Enforcement
    Class II ·Terminated·American Contract Systems·June 10, 2020

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020

    LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402, BA2700, BT2000, BT2101, BT2103, BT2105, BT2106, BT2210, BT2201, BT2203, BT2205, BR2200, BP2200, BI2200, BR2000, BP2000, BI2999, BR2103, BP2103, BI2103, BR2101, BP2101, BI2101, BI2001, BDL2420

    FDA Enforcement
    Class II ·Terminated·Lymol Medical Corporation·October 6, 2021

    HEMO-7 Hemospray Endoscopic Hemostat

    FDA Enforcement
    Class II ·Terminated·Wilson-Cook Medical Inc.·April 29, 2020

    HEMO-10 Hemospray Endoscopic Hemostat

    FDA Enforcement
    Class II ·Terminated·Wilson-Cook Medical Inc.·April 29, 2020

    Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

    FDA Enforcement
    Class II ·Terminated·Avid Medical, Inc.·March 25, 2020

    CardioTek EP-TRACER Software V2.x.

    FDA Enforcement
    Class II ·Completed·CardioTek BV·June 29, 2022

    Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

    FDA Enforcement
    Class II ·Terminated·Avid Medical, Inc.·March 25, 2020

    Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral agents

    FDA Enforcement
    Class II ·Terminated·Hardy Diagnostics·December 30, 2020

    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 26, 2014

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023