BEUDAMED
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    Straumann Variobase for Crown AS

    FDA 510(k)
    FDA Class 2 ·Dental

    Ponto

    FDA UDI
    Oticon Medical AB·05712149013944·Ponto Soft band, cerise

    TELIO CS INLAY & TELIO CS ONLAY

    FDA 510(k)
    FDA Class 2 ·Dental

    ABBOTT ARCHITECT FREE T4

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MIO ADVANCE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code FPA·July 20, 2021

    OPTICROSS?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code OBJ·October 15, 2014

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·July 23, 2011

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 17, 2013

    ZOLL IVTM THERMOGARD XP

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION·Product code NCX·July 20, 2022

    ZOLL IVTM THERMOGARD XP

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION·Product code NCX·July 20, 2022

    SYNERGY

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 25, 2015

    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