BEUDAMED
    20 results · 21ms · Sources: EU EUDAMED, US FDA

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    INNOVA EPVISION 2.0, INNOVA EPVISION 2.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450187494·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450187852·

    SMITH & NEPHEW, INC SPATIALFRAME V4.1 WEB-BASED SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    1.5MM RESORB ORBITAL FLOOR PL 24MMX24MM W/BENDING TEMP-STER

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code JEY·November 2, 2012

    Widex

    FDA UDI
    Widex A/S·05706069671568·Widex EVOKE E-FA (Summer gold ) 330, Telecoil, ...

    Widex

    FDA UDI
    Widex A/S·05706069671940·Widex EVOKE E-FP (Summer gold ) 330, Telecoil, ...

    Widex

    FDA UDI
    Widex A/S·05706069556339·Widex D-FA P (Summer gold ) Dream 330, Telecoil...

    Widex

    FDA UDI
    Widex A/S·05706069564112·Widex UNIQUE U-FP (Summer gold ) 330, Telecoil,...

    Widex

    FDA UDI
    Widex A/S·05706069553642·Widex UNIQUE U-FA (Summer gold ) 330, Telecoil,...

    Widex

    FDA UDI
    Widex A/S·05706069575620·Widex UNIQUE U-FM (Summer gold ) 330, RC coil

    Widex

    FDA UDI
    Widex A/S·05706069671216·Widex EVOKE E-FM (Summer gold ) 330, RC coil

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·May 24, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 30, 2014

    CAPSUREFIX NOVUS

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

    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

    Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes..

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

    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