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

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    SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP, SAVANNAH-T, LOW-TOP, SAVANNAH-LINK

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Sonic

    FDA UDI
    Sonic Innovations, Inc.·05711583024363·CH40 ITED, R BE CHARM 40

    B&R DEVICE

    FDA 510(k)
    FDA Class 1 ·Dental

    NEXGEN EXPANDABLE CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HI-TORQUE WHISPER ES GUIDE WIRE

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

    SENSIA DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code NVZ·June 17, 2011

    ADAC PINNACLE TREATMENT PLANNING SYSTEM

    FDA Adverse Event
    Injury ·PHILLIPS MEDICAL SYSTEMS·Product code MUJ·August 13, 2008

    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