BEUDAMED
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    POLARIS SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ROD, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019

    ILIAC SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MNH·October 16, 2019

    POLARIS SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·January 8, 2020

    POLARIS TRANSLATION SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·November 27, 2019

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450205815·

    BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·May 2, 2013

    CORT SCREW 5.5MM X 45MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HSB·July 30, 2008

    ARIA RADIATION ONCOLOGY

    FDA Adverse Event
    Malfunction ·VARIAN MEDICAL SYSTEMS INC.·Product code IYE·April 19, 2011

    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026