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    SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SHINA CORP.

    FDA registration
    SHINA CORP.·5 products·🇰🇷 South Korea

    UCLA AND UNIVERSAL ABUTMENTS

    FDA 510(k)
    FDA Class 2 ·Dental

    SCANDINAVIAN IVF SCIENCES AB, G2.2

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    TESS GLENOID REVERSE HEAD DIAMETER 36

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code KWS·October 27, 2016

    STERRAD 100NX STERILIZER

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·April 8, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS·Product code JAA·March 22, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·August 27, 2014

    FACSCALIBUR¿

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·April 26, 2019

    Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD).

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging·March 23, 2016

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024