BEUDAMED
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    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. LOT Number 4330832. Product not distributed in US, UDI: 1 0840619 04197 4

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code DQE·January 2, 2020

    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41414-23

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code DQE·January 2, 2020

    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 50456-01

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code DQE·January 2, 2020

    Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197532

    FDA Recall
    Terminated ·Edwards Lifesciences, LLC·Product code DQE·July 9, 2021

    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41401-25.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code DQE·January 2, 2020

    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41401-23.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code DQE·January 2, 2020

    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41411-25

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code DQE·January 2, 2020

    Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181

    FDA Recall
    Terminated ·Edwards Lifesciences, LLC·Product code DQE·March 27, 2020

    Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197563

    FDA Recall
    Terminated ·Edwards Lifesciences, LLC·Product code DQE·July 9, 2021

    Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, Rx Only, Sterile EO, UDI: (01)00690103197495 *NOT DISTRIBUTED WITHIN THE US

    FDA Recall
    Terminated ·Edwards Lifesciences, LLC·Product code DQE·July 9, 2021

    Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197525 *NOT DISTRIBUTED WITHIN THE US

    FDA Recall
    Terminated ·Edwards Lifesciences, LLC·Product code DQE·July 9, 2021

    Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197556

    FDA Recall
    Terminated ·Edwards Lifesciences, LLC·Product code DQE·July 9, 2021

    Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3, Rx Only, Sterile EO, UDI: (01)00690103197501 *NOT DISTRIBUTED WITHIN THE US

    FDA Recall
    Terminated ·Edwards Lifesciences, LLC·Product code DQE·July 9, 2021

    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41406-23

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code DQE·January 2, 2020

    nordicBrainEX, software versions 2.21 through 2.3.10

    FDA Enforcement
    Class II ·Terminated·NordicNeuroLab AS·August 3, 2022

    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

    Proteus 235 Proton Therapy System for cancer treatment.

    FDA Enforcement
    Class II ·Terminated·Ion Beam Applications S.A.·November 5, 2014

    Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; part number 110-0234G1 (domestic) and 110-0234G3 (international) The Orthoralix 8500 DDE Panoramic Dental X-Ray System is used as an extraoral source of x-rays for imaging of the dento-maxillofacial area.

    FDA Recall
    Terminated ·Gendex Dental Systems·Product code EHD·December 21, 2010