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

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    OLYMPUS EMPOWER H65

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM S.P.A.·Product code GEX·May 19, 2022

    Empower H65

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

    MAESTRO TOTAL WRIST

    FDA UDI
    Biomet Orthopedics, LLC·00880304555143·

    Maestro™ Total Wrist

    FDA UDI
    Biomet Orthopedics, LLC·00887868239984·

    DERMABOND NX ADHESIVE MODEL: DNX6, DNX12

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

    INTEGRE, MODEL LP581

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 6, 2020

    NEEDLE 18GA 2IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·December 26, 2019

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 27, 2011

    STERLING?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·June 20, 2013

    MONOJECT PREFILL ADVANCED

    FDA Adverse Event
    Death ·TYCO HEALTHCARE GROUP LP·Product code NZW·September 29, 2008

    ENNOVATE POLYAX.SCREW 6.5X45MM FENESTR.

    FDA Adverse Event
    Injury ·AESCULAP AG·Product code NKB·December 21, 2018

    ENNOVATE POLYAX.SCREW 7.5X40MM FENESTR.

    FDA Adverse Event
    Injury ·AESCULAP AG·Product code NKB·December 21, 2018

    GMK SPHERE TIBIAL INSERT

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·July 31, 2018

    Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022

    syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·July 13, 2022

    SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR).

    FDA Enforcement
    Class II ·Terminated·Shimadzu Medical Systems Usa Com·March 27, 2019

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025