BEUDAMED
    105 results · 14ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × 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

    UP & UP kids' power toothbrush

    FDA Enforcement
    Class II ·Terminated·Ranir Corporation·January 29, 2014

    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

    TopCare Clifford THE BIG RED DOG power toothbrush for kids!

    FDA Enforcement
    Class II ·Terminated·Ranir Corporation·January 29, 2014

    Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3 different sizes (sm, med, lg) that can be used in children ages 3-15 to address breathing and myofunctional disorders. Catalog Numbers:

    FDA Enforcement
    Class II ·Ongoing·Myofunctional Research Company USA·December 24, 2025

    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

    Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)

    FDA Enforcement
    Class II ·Completed·Basic Reset Inc.·November 20, 2019