BEUDAMED
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    QUANTAFLUOR FLUORESCENT TEST REAGENTS

    FDA 510(k)
    FDA Class 2 ·Immunology

    Bioplate®

    FDA UDI
    Bioplate, Inc.·M3848135920·Burr Hole Cover - Low-Profile - 18 mm (1), Self...

    Bioplate®

    FDA UDI
    Bioplate, Inc.·M384813592US0·Burr Hole Cover - Low-Profile - 18 mm (1), Self...

    ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer

    FDA 510(k)
    FDA Class 2 ·Hematology

    EXTREMITY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    32MM DIA COCR MOD HEAD +9MM NK

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·May 15, 2014

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·October 31, 2012

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·August 25, 2010

    Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 28, 2025

    Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·May 13, 2025

    Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;

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

    Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;

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

    Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026