BEUDAMED
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    LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    Oticon

    FDA UDI
    Oticon A/S·05707131261090·H10, MINIRITE 312 WL SIL

    DreamWear Full

    FDA UDI
    Respironics, Inc.·00606959046078·DreamWear Full Mask, Small, with Small Frame, w...

    SECURVIEW DX DIAGNOSTIC WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    DGH 55 HANDHELD PACHYMETER (PACHMATE)

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 29, 2025

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 5, 2024

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 29, 2013

    PFC SIGMA C/S NPOR FEM LT SZ 4

    FDA Adverse Event
    Injury ·DEPUY (IRELAND)·Product code JWH·June 13, 2011

    ULTRATINE FOREHEAD 3.0

    FDA Adverse Event
    Injury ·COAPT SYSTEMS, INC.·Product code HWC·August 22, 2008

    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