BEUDAMED
    550 results · 10ms · Sources: EU EUDAMED, US FDA

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

    Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video Ext, IP PTZ HD ErgoJust Video Extension, EuroJust ICU Cart Export For PTZ Video Ext. Video cart used for mobile medical record documentation.

    FDA Enforcement
    Class II ·Terminated·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·August 15, 2018

    Capnostream20 M ADULT ICU (CPM), CS08654RA

    FDA Enforcement
    Class II ·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018

    DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors

    FDA Enforcement
    Class II ·Terminated·DeRoyal Industries Inc·September 7, 2022

    ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·May 6, 2020

    Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·August 27, 2014

    CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·August 27, 2014

    Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·August 27, 2014

    NanoClave Stopcock, Part No. A1000, Item No. 011-AC100 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·January 15, 2014

    8" Ext Set w/NanoClave" Stopcock, Clamp, Rotating Luer, Part No. A1000, Item No. AC102 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·January 15, 2014

    10" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1071 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·January 15, 2014

    8" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1070 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·January 15, 2014

    5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Luer Slip, Item # B3303-T, Lot # 2791243. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·January 15, 2014

    5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B33101-T, Lot # 2791358. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·January 15, 2014

    5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B3304-T, Lot # 2791244. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·January 15, 2014

    7" (18 cm) Appx 0.26 ml, Smallbore Ext Set w/MicroClave¿ Clear, NThe ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.anoClave", Clamp, Luer Lock, Part No. A1000, Item No. K7089-001

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·January 15, 2014

    11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Part No. A1000, Item No. K7105-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·January 15, 2014

    7" (18 cm) Appx 0.24 ml, Smallbore Ext Set w/NanoClave", Clamp, Luer Lock, Part No. A1000, Item No. K7095-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·January 15, 2014

    5" (13 cm) Appx 0.23 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. Z3845 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·January 15, 2014

    6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector, Rotating Luer, Part No. A1000, Item No. K7084-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·January 15, 2014

    11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Part No. A1000, Item No. A1052 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·January 15, 2014