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

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    VASOTHERM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Sklar Instruments

    FDA UDI
    SKLAR CORPORATION·10649111493089·ECONO STERILE ARMY RETR (SET OF 2) STER CS25

    CHARNLEY

    FDA UDI
    DEPUY INTERNATIONAL LTD·10603295241683·CHARNLEY CEMENT RESTRICTOR INTRODUCER MODIFIED

    TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    CHEMOLOCK

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code ONB·October 28, 2020

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·February 15, 2023

    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243; 2) ECONO STERILE ARMY RETR (SET OF 2)STRL CS/25, Model Number 96-2243M; 3) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267; 4) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267A; 5) ECONO STERILE SENN RETR DE SH 6.25"STRLCS/25, Model Number 96-2269A; 6) ECONO STERILE MINI HOHMANN 6MM 6.5" STERCS25, Model Number 96-2959; retractors

    FDA Enforcement
    Class II ·Ongoing·Sklar Instruments·January 22, 2025

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·February 14, 2013

    ALTRUA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·January 18, 2011

    AFX SYSTEM

    FDA Adverse Event
    Death ·ENDOLOGIX, INC.·Product code MIH·July 28, 2014

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·July 26, 2024

    NSK

    FDA Adverse Event
    Malfunction ·NAKANISHI INC.·Product code EFB·September 17, 2025

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·February 18, 2019

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·February 18, 2019

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·February 18, 2019

    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243; 2) ECONO STERILE ARMY RETR (SET OF 2)STRL CS/25, Model Number 96-2243M; 3) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267; 4) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267A; 5) ECONO STERILE SENN RETR DE SH 6.25"STRLCS/25, Model Number 96-2269A; 6) ECONO STERILE MINI HOHMANN 6MM 6.5" STERCS25, Model Number 96-2959; retractors

    FDA Recall
    Open, Classified ·Sklar Instruments·Product code GAD·December 3, 2024