BEUDAMED
    11 results · 26ms · Sources: EU EUDAMED, US FDA

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    XLD AGAR

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ERA® Micro Ovd. Processing Jig.

    FDA UDI
    STERNGOLD DENTAL LLC·00841549116155·Used to replicate the ERA Overdenture Female in...

    AURADONICS

    FDA UDI
    AURADONICS INC.·00810033835414·LATEX ELASTICS 3/16" 4.5 oz. - NEON, 10000 ea.,...

    Bioplate®

    FDA UDI
    Bioplate, Inc.·M3848110420·BioMesh® 3MC - 50 x 50 mm

    ATRICURE CRYO MODULE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 9, 2014

    PULSE-GENERATOR, PACEMAKER, EXTERNAL

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA, INC.·Product code DTE·October 31, 2012

    PUMP MMT-722NAS PRDGM INS V2.2 SK EN

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·August 10, 2010

    Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera 1.5T Master/Nova Model 781106, 4) Intera 1.5T Master CV Model 781107, 5) Intera 1.5T Explorer/ Nova Dual Model 781108, 6) Intera 1.5T IT Model 781160, 7) Intera 1.5T Pulsar Model 781170, 8) Intera 1.5T Achieva Pulsar Model 781171, 9) Intera 1.5T Achieva Nova Model 781172, 10) Intera 1.5T Achieva CV Nova Model 781174, 11) Intera 1.5T Achieva IT Nova Model 781174, 12) Intera 1.5T Achieva I/T Nova Dual Model 781176, 13) Intera 1.5T Model 781195, 14) Intera 1.5T Pulsar New Model 781295, (Added 6/25/18) 15) Intera 1.5T Enterprise

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code LNH·March 16, 2018

    Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera 1.5T Master/Nova Model 781106, 4) Intera 1.5T Master CV Model 781107, 5) Intera 1.5T Explorer/ Nova Dual Model 781108, 6) Intera 1.5T IT Model 781160, 7) Intera 1.5T Pulsar Model 781170, 8) Intera 1.5T Achieva Pulsar Model 781171, 9) Intera 1.5T Achieva Nova Model 781172, 10) Intera 1.5T Achieva CV Nova Model 781174, 11) Intera 1.5T Achieva IT Nova Model 781174, 12) Intera 1.5T Achieva I/T Nova Dual Model 781176, 13) Intera 1.5T Model 781195, 14) Intera 1.5T Pulsar New Model 781295, (Added 6/25/18) 15) Intera 1.5T Enterprise

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·April 25, 2018