BEUDAMED
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    Q-Switched Nd:YAG Laser System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    UHEAD

    FDA UDI
    Stryker GmbH·00886385013527·Stem Trial; Std. Collar; Size 2

    SYNGO.VIA WEB VIEWER

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200

    FDA 510(k)
    FDA Unclassified ·Unknown

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·July 8, 2011

    ASR ACETABULAR CUPS 60

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·June 14, 2013

    SERVO-I

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·July 15, 2014

    ENDURANT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·October 16, 2014

    TALENT AAA STENT GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·October 16, 2014

    CUSTOM PACK CB1Q91R6 NTUH CCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO·Product code DWE·June 22, 2022

    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 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 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