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

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    NXSTAGE SYSTEM ONE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ArgenZ HT+ 98x18 OM1

    FDA UDI
    ARGEN CORPORATION, THE·D818122051·Dental porcelain/ceramic restoration kit

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 30, 2015

    SOUNDVASER SYSTEM

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

    PAIN BUDDY

    FDA 510(k)
    FDA Class 2 ·Neurology

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    FDA Adverse Event
    Injury ·GUIDANT ENDOVASCULAR SOLUTIONS·Product code NFA·June 22, 2006

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·May 21, 2013

    SYMBIQ SINGLE CHANNE

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 24, 2011

    PROXIMATE RELOADABLE LINEAR STAPLER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 14, 2008

    COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code MPB·February 13, 2017

    SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·April 9, 2025

    Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    SOMATOM Edge Plus-Computed tomography system Model 1026700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022

    SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021

    Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus (Model #10267000)

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·October 7, 2020