BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    QB TEST

    FDA 510(k)
    FDA Unclassified ·Unknown

    Oticon

    FDA UDI
    Oticon A/S·05707131261069·H10, MINIRITE 312 WL STG

    DreamWear Full

    FDA UDI
    Respironics, Inc.·00606959046054·DreamWear Full Mask, Large, with Medium Frame w...

    INTERCONTINENTAL PLATE-SPACER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    530G INSULIN PUMP

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

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MAF·May 29, 2013

    UNKNOWN DEPUY TIBIAL INSERT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·June 13, 2011

    VASO VIEW HEMOPRO

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 15, 2019

    Philips Respironics DreamWear Full Face Mask

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

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    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