BEUDAMED
    21 results · 29ms · Sources: EU EUDAMED, US FDA

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    PREMIER CERAMIC PRIMER

    FDA 510(k)
    FDA Class 2 ·Dental

    Trivicta

    FDA UDI
    Ortho Development Corporation·00822409123902·Collar EXT Size 12

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167311312120·

    TALOS® HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167321312120·

    TALOS®-A

    FDA UDI
    SpineArt SA·07640375237415·TALOS®-A (HA) PEEK PLANAR, SYMMETRIC IBFD D24 ...

    STILLE Chisels

    FDA UDI
    Stille AB·07332339206482·CHISEL ORIGINAL STILLE 12 mm 16.5 cm 6.5 in

    MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TEMPORARY RESIN CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    980 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·December 14, 2016

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·August 2, 2019

    CG FUTURE BAND

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·October 15, 2018

    GREENLIGHT MOXY FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS·Product code GEX·May 23, 2013

    ENDOPATH XCEL

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC·Product code GCJ·September 22, 2014

    CAPSUREFIX NOVUS MRI

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

    ZELTIQ COOLCORE (6.3)

    FDA Adverse Event
    Injury ·ZELTIQ AESTHETICS INC.·Product code OOK·June 19, 2014

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 10, 2021

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·October 26, 2021

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·May 16, 2023

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DYE·April 27, 2020

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015