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    UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SIGMA

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295245636·SIGMA RP STABILIZED TIBIAL INSERT TRIAL 2 22.5mm

    De Soutter Medical

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

    DEMETRON A.2

    FDA 510(k)
    FDA Class 2 ·Dental

    Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3

    FDA 510(k)
    FDA Class 2 ·Radiology

    EXPORT ASPIRTAION CATHETER

    FDA Adverse Event
    Injury ·MEDTORNIC, INC·Product code DXE·February 15, 2013

    VANGUARD DCM SSK PS TIBIAL BEARING 10MM X 71/75MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·January 18, 2011

    PROXIMATE ILS STAPLER

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 29, 2014

    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