BEUDAMED
    205 results · 22ms · Sources: EU EUDAMED, US FDA

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    Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.

    FDA Recall
    Terminated ·Ormco/Sybronendo·Product code DZC·November 4, 2015

    EZ Breathe Medication Cup. For the delivery of liquid medications for respiratory usage.

    FDA Enforcement
    Class I ·Terminated·Nephron Pharmaceuticals Corp.·June 5, 2013

    Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number: IAB-05840-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·April 17, 2013

    Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·April 17, 2013

    Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·June 30, 2021

    Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·June 30, 2021

    EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.

    FDA Enforcement
    Class I ·Terminated·Nephron Pharmaceuticals Corp.·June 5, 2013

    Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·March 18, 2015

    AsthmaNefrin Starter Kit contains ten (10) AsthmaNefrin vials and one (1) EZ Breathe Atomizer. For the delivery of liquid medications for respiratory usage.

    FDA Enforcement
    Class I ·Terminated·Nephron Pharmaceuticals Corp.·June 5, 2013

    Alinity i Estradiol Reagent Kit, List Number 07P5020

    FDA Enforcement
    Class II ·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019

    Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121

    FDA Enforcement
    Class II ·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019

    Alinity i Progesterone Reagent Kit, List Number 08P3620

    FDA Enforcement
    Class II ·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019

    Alinity i Free T4 Reagent Kit, List Number 07P7030

    FDA Enforcement
    Class II ·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019

    RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

    FDA Enforcement
    Class I ·Terminated·Arrow International, Inc., Division of Teleflex Medical Inc.·March 16, 2016

    Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532

    FDA Enforcement
    Class II ·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019

    Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

    FDA Enforcement
    Class I ·Terminated·Arrow International, Inc., Division of Teleflex Medical Inc.·March 16, 2016

    Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

    FDA Enforcement
    Class I ·Terminated·Arrow International, Inc., Division of Teleflex Medical Inc.·March 16, 2016

    UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

    FDA Enforcement
    Class I ·Terminated·Arrow International, Inc., Division of Teleflex Medical Inc.·March 16, 2016

    UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

    FDA Enforcement
    Class I ·Terminated·Arrow International, Inc., Division of Teleflex Medical Inc.·March 16, 2016

    Alinity i TSH Reagent Kit, List Number 07P4830

    FDA Enforcement
    Class II ·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019