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    MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A

    FDA 510(k)
    FDA Class 2 ·Radiology

    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

    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

    AGXO

    FDA UDI
    Oticon A/S·05707131262240·H110, RITE 312 WL TC AGXO

    NOYES IRIS SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896014602·NOYES IRIS SCISSORS CURVED SHARP TIPS FLAT HANDLE

    Zavation

    FDA UDI
    Zavation LLC·00197157006167·Custom Tap/3.5mm

    E-SARANG 86, DM78, DM55

    FDA 510(k)
    FDA Class 2 ·Dental

    ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 29, 2025

    EMAX 2 PLLUS

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 1, 2014

    SABO SAG SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HRX·May 29, 2013

    QUATTRODE LEAD WIDE SPACED, 60 CM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 15, 2011

    Philips Respironics DreamWear Full Face Mask

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

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023