BEUDAMED
    38 results · 9ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C, G8G8FS DF - ARD568121131C

    FDA Enforcement
    Class II ·Ongoing·Getinge Usa Sales Inc·January 24, 2024

    Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·February 3, 2021

    Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·February 3, 2021

    Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·February 3, 2021

    BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.

    FDA Enforcement
    Class II ·Terminated·Surgical Specialties Mexico S DE RL DE CV·October 19, 2016

    40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.

    FDA Enforcement
    Class II ·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018

    61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer, 2 Ext.

    FDA Enforcement
    Class II ·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018

    6" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer.

    FDA Enforcement
    Class II ·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018

    10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer.

    FDA Enforcement
    Class II ·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018

    10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer

    FDA Enforcement
    Class II ·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018

    DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifold, Check Valve, Rotating Luer, Filter Cap is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.

    FDA Enforcement
    Class II ·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018

    10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow, Green Rings), NanoClave (Light Blue Ring), Check Valve, Clamp, Rotating Luer.

    FDA Enforcement
    Class II ·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018

    30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.

    FDA Enforcement
    Class II ·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018

    11" Smallbore Ext Set w/NanoClave, 6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer.

    FDA Enforcement
    Class II ·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018

    20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system.

    FDA Enforcement
    Class II ·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018

    28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer.

    FDA Enforcement
    Class II ·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018

    165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.

    FDA Enforcement
    Class II ·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018

    Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear

    FDA Enforcement
    Class II ·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018

    43 cm (17") Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.

    FDA Enforcement
    Class II ·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018

    38 cm (15") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer.

    FDA Enforcement
    Class II ·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018