BEUDAMED
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    XGEO GR40CW

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257125212·20-30 MV FOR MEN CLSC CALF STD GREY V

    DreamWear Full

    FDA UDI
    Respironics, Inc.·00606959054448·DreamWear Full Mask, Small, with Medium Frame w...

    Fuji Cervical Plate System

    FDA UDI
    Altus Spine, LLC·B41711402351·35mm Level 2 Cervical Plate System - Fuji

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690199670·Modular Knee Stem Pilot 23mm x 150mm

    FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE

    FDA 510(k)
    FDA Class 2 ·Dental

    LICOX PMO BRAIN MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    Truliant

    FDA UDI
    Exactech, Inc.·10885862315014·Truliant CR Porous Femoral

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·June 26, 2019

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 3, 2023

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·October 24, 2022

    T:SLIM X2 INSULIN PUMP

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OYC·September 3, 2019

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 31, 2013

    UNICEL® DXC 600 PRO SYNCHRON ® CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·June 26, 2011

    GORE TAG THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES, INC·Product code MIH·August 29, 2008

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    Philips Respironics DreamWear Full Face Mask

    FDA Enforcement
    Class I ·Ongoing·Philips Respironics, Inc.·October 12, 2022

    TRULIANT KNEE COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·July 17, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    TRULIANT TIB IMP CRC INSERT SZ 3.5,10MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·September 20, 2022