BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    CLEARVIEW

    FDA 510(k)
    FDA Class 2 ·Radiology

    HHM

    FDA UDI
    Oticon A/S·05707131261045·H100, MINIRITE 312 WL DBL HHM

    DreamWear Full

    FDA UDI
    Respironics, Inc.·00606959046344·DreamWear Full Face Mask, Medium-Wide Cushion, ...

    SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    MONOJECT INSULIN SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    COMP RVRS 25MM BSPLT HA+ADPTR

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·March 8, 2021

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 1, 2014

    FREESTYLE FREEDOM

    FDA Adverse Event
    Malfunction ·Product code NBW·May 29, 2013

    HORIZON APPLIER LARGE APPLIER 11" CURVED

    FDA Adverse Event
    Death ·TELEFLEX MEDICAL·Product code FZP·June 15, 2011

    Philips Respironics DreamWear Full Face Mask

    FDA Enforcement
    Class I ·Ongoing·Philips Respironics, Inc.·October 12, 2022

    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