BEUDAMED
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    Microlife Digital Infrared Ear Thermometer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Vanguard Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304673953·

    Vanguard Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304648036·

    PACP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SONIXTABLET ULTRASOUND SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    TABOTAMP SNOW ABS

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code LMG·October 30, 2019

    TABOTAMP SNOW ABS

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code LMG·October 30, 2019

    TABOTAMP SNOW ABS

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code LMG·October 30, 2019

    TABOTAMP SNOW ABS

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code LMG·October 30, 2019

    TABOTAMP SNOW ABS

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code LMG·October 30, 2019

    TABOTAMP SNOW ABS

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code LMG·October 30, 2019

    FUJIFILM DOUBLE BALLOON ENDOSCOPES EN-450T5/W

    FDA Adverse Event
    Death ·FUJIFILM CORPORATION·Product code FDA·January 26, 2024

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008

    M2A-MAGNUM MODULAR HEAD SIZE 46MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 22, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 8, 2011

    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