BEUDAMED
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    HEPATIC VCAR

    FDA 510(k)
    FDA Class 2 ·Radiology

    Poly Surgiclip

    FDA UDI
    Covidien LP·10884521133679·Clip Applier with Polysorb Clips

    SILK ROAD ACCESS CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VOLUSON S6, VOLUSON S8

    FDA 510(k)
    FDA Class 2 ·Radiology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 1, 2014

    REPLY

    FDA Adverse Event
    Injury ·SORIN C.R.M., S.R.L.·Product code NVZ·June 16, 2011

    840 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN·Product code CBK·October 7, 2015

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015