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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Enforcement × Classification: Class Ii × Clear all

    25-LHP-928, HeNe Laser System, 25 mW

    FDA Enforcement
    Class II ·Ongoing·PACIFIC LASERTECH, LLC·September 18, 2024

    25-LHP-828, HeNe Laser System, 35 mW

    FDA Enforcement
    Class II ·Ongoing·PACIFIC LASERTECH, LLC·September 18, 2024

    N-LHP-928, HeNe Laser System, 35 mW

    FDA Enforcement
    Class II ·Ongoing·PACIFIC LASERTECH, LLC·September 18, 2024

    NaviNetics Skull Anchor Key and Drill Kit, REF NN1215

    FDA Enforcement
    Class II ·Ongoing·Navinetics Inc·April 10, 2024

    Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as a power supply alone.

    FDA Enforcement
    Class II ·Ongoing·Newport Corp·June 12, 2024

    ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.

    FDA Enforcement
    Class II ·Completed·Aesculap Implant Systems LLC·July 27, 2022

    2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 26, 2023

    AVANOS MIC-KEY SF Gastrostomy Feeding Tube

    FDA Enforcement
    Class II ·Terminated·Avanos Medical, Inc.·September 23, 2020

    ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

    FDA Enforcement
    Class II ·Terminated·Aesculap Implant Systems LLC·July 27, 2022

    Fresenius 2008T Series Hemodialysis System

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·January 25, 2017

    Fresenius 2008K Series : Hemodialysis System

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·January 25, 2017

    Fresenius 2008K2 Series : Hemodialysis System

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·January 25, 2017

    Fresenius 2008K@home Series : Hemodialysis System

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·January 25, 2017

    SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 26, 2023

    Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·February 7, 2018

    The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·October 2, 2024

    Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 10, 2026

    Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 10, 2026

    Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 10, 2026

    Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 10, 2026