BEUDAMED
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    KAPPA IMMAGE FREELITE KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    MEDIVISION I-VIEW PERSONAL VIDEO DISPLAY

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HANGER CRANIAL BAND

    FDA 510(k)
    FDA Class 2 ·Neurology

    TENDRIL MRI

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NVN·October 29, 2025

    TENDRIL MRI

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NVN·October 29, 2025

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION INC.·Product code DRM·February 11, 2013

    COONRAD / MORREY PIN / BUSHING REPLACEMENT KIT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JDC·February 23, 2011

    PROXIMATE ILS CURVED CIR STAPL

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GDW·February 14, 2008

    LL VLV ADPT(STAND ALONE)

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.·Product code FPA·June 11, 2020

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; 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