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

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    CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE

    FDA 510(k)
    FDA Class 2 ·Radiology

    BENCHMARK ELECTRONICS, INC.

    FDA registration
    BENCHMARK ELECTRONICS, INC.·48 products·🇺🇸 United States

    ELATION® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807133641601·ELATION® MB Base Rx 018/L4 -17T

    ELATION® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807133641611·ELATION® MB Base Rx 018/L4 -17T HK

    GUARDACARE

    FDA 510(k)
    FDA Unclassified ·Unknown

    SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 1, 2014

    PENTA

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, NEUROMODULATION·Product code LGW·May 20, 2013

    ACRYSOF RESTOR

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·June 16, 2011

    ADVIA CENTAUR INTACT PTH (IPTH) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·February 24, 2016

    ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·January 7, 2015

    ADVIA CENTAUR INTACT PTH (IPTH) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·December 19, 2014

    ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·November 1, 2016

    ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·February 29, 2016

    ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·June 15, 2016

    ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·August 30, 2016

    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