BEUDAMED
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    MRopen EVO

    FDA 510(k)
    FDA Class 2 ·Radiology

    ECHO BI-METRIC MICROPLASTY HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304697980·

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690127154·AK3 PS Insert Trial Size 1, 16mm

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471129443·K-WIRE - DOUBLE TROCAR WITH GUIDE 1.1mm DIA x 1...

    AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MODIFICATION TO: RAMP INFLUENZA A/B ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TRIO CONNECTOR 3.5 MM HEX SOCKET FOR TORQUE WRENCH

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code HXC·October 6, 2008

    HT70 VENTILATOR

    FDA Adverse Event
    Malfunction ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·June 25, 2013

    ARMADA 14 PTA CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LIT·August 5, 2011

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

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

    Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

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

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

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

    Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

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