BEUDAMED
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    MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    devemed

    FDA UDI
    devemed GmbH·04061644057955·GESystem ADULT | F-LINE black edition Extractin...

    devemed

    FDA UDI
    devemed GmbH·04061644032259·GENTLE EXTRACT SYSTEM ADULT | F-LINE Extracting...

    DIGITAL ULTRASOUND SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    VERSYS BEADED FULLCOAT BOWED REVISION HIP PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DORMA 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·March 16, 2022

    125° RADIOLUCENT TARGETING ARM

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code LXH·September 25, 2023

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

    EPIC II CRITICAL CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 24, 2013

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    JUMAO HEALTHCARE EQUIPMENT·Product code IOR·September 30, 2014

    syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Model Number 11061670. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·May 4, 2022

    syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro and SOMATOM X.cite Material Numbers: 11061620 11061628 11061630 11061640 11061660 11061670

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    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