BEUDAMED
    18 results · 18ms · Sources: EU EUDAMED, US FDA

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    BUN (UREASE) REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331136528·freeman areola marker, improved pattern, 42.0 m...

    Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;

    FDA Enforcement
    Class II ·Ongoing·Philips North America·August 6, 2025

    Achieva XR Product Numbers: (1) 781153, (2) 781253;

    FDA Enforcement
    Class II ·Ongoing·Philips North America·June 18, 2025

    Achieva XR Product Numbers: (1) 781153, (2) 781253;

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·May 29, 2025

    Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·June 30, 2025

    ZIRDENT CAD/CAM BLOCKS

    FDA 510(k)
    FDA Class 2 ·Dental

    Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·April 30, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 10, 2012

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·May 19, 2015

    Achieva XR. Model (REF) Numbers 781153, 781253.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·February 7, 2024

    Achieva XR. Model (REF) Numbers 781153, 781253.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNI·January 3, 2024

    Achieva XR 1.5T/3.0T , Model Number 781253. Nuclear Magnetic Resonance Imaging System

    FDA Recall
    Terminated ·Philips Medical Systems Nederlands Veenpluis 4-6 Best Netherlands·Product code LNH·December 21, 2018

    Achieva XR 1.5T/3.0T , Model Number 781253. Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Nederlands·March 6, 2019

    AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781253

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·May 3, 2024

    Achieva XR, Magnetic Resonance System.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 24, 2024

    AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781253

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024