BEUDAMED
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    VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040059880·Premium Needles 27Ga Long

    SoundBite® Active Wire 14P

    FDA UDI
    Soundbite Medical Solutions Inc·17540265101024·The SoundBite® Active Wire 14P which is part o...

    SoundBite® Active Wire 14P

    FDA UDI
    Soundbite Medical Solutions Inc·10754026501023·The SoundBite® Active Wire 14P which is part o...

    PREMIUM PLUS CEEA

    FDA Adverse Event
    Malfunction ·US SURGICAL PUERTO RICO·Product code GDW·April 19, 2018

    MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DRX HBA1C - FOR PRESCRIPTION HOME USE

    FDA 510(k)
    FDA Class 2 ·Hematology

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 12, 2013

    FREESTYLE LITE

    FDA Adverse Event
    Injury ·Product code NBW·February 25, 2011

    FREESTYLE FREEDOM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·February 19, 2008

    NIBP CUFFS

    FDA Adverse Event
    Injury ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code OED·August 8, 2025

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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