BEUDAMED
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    STAR RF Ablation System

    FDA 510(k)
    FDA Class 2 ·Neurology

    NITREX™

    FDA UDI
    EV3, INC·00763000185473·GW N251802 NITREX V04

    NITREX

    FDA UDI
    Covidien LP·00821684058237·Guidewire

    NITREX

    FDA UDI
    Covidien LP·10821684009106·Guidewire

    FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Resolution Clip

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RESOLUTION 360 CLIP

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code PKL·December 2, 2024

    BEBACK CROSSING CATHETER

    FDA Adverse Event
    Malfunction ·BENTLEY INNOMED GMBH·Product code PDU·December 23, 2025

    BEBACK CROSSING CATHETER

    FDA Adverse Event
    Malfunction ·BENTLEY INNOMED GMBH·Product code PDU·November 21, 2025

    BEBACK CROSSING CATHETER

    FDA Adverse Event
    Malfunction ·BENTLEY INNOMED GMBH·Product code PDU·April 30, 2025

    BEBACK CROSSING CATHETER

    FDA Adverse Event
    Malfunction ·BENTLEY INNOMED GMBH·Product code PDU·March 6, 2025

    TENDRIL SDX

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·November 14, 2014

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·August 31, 2011

    VERISYSE OR ARTISAN PHAKIC INTRAOCULAR LENS

    FDA Adverse Event
    Injury ·OPHTEC BV·Product code MTA·July 18, 2013

    Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

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

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, 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 Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, 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 Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

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