BEUDAMED
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    MODEL 520A NOVAMETRIX PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377069221·RELINE C Screw, 3.5x16mm FA

    Fixion Nailing System

    FDA UDI
    CARBOFIX ORTHOPEDICS LTD·07290109331126·Cortical screw for use with humeral nails

    WARMTOUCH COMPACT WARMING UNIT

    FDA Adverse Event
    Malfunction ·COVIDIEN/FORMERLY TYCO·Product code DWJ·December 23, 2010

    INVACARE ELEVATING SEAT OPTION ESS6

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    THERASOM-CAST

    FDA 510(k)
    FDA Class 2 ·Dental

    WARM TOUCH II COMPACT WARMING UNIT

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code DWJ·September 24, 2010

    CAPIOX HEMOCONCENTRATOR

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code KDI·March 3, 2016

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·November 24, 2010

    SELUTE PICOTIP

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 3, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 21, 2012

    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 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

    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