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

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    NIGHTGUARD DIAGNOSTIC APPLIANCE

    FDA 510(k)
    FDA Unclassified ·Unknown

    PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·May 4, 2022

    PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code KDI·March 15, 2022

    The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KDI·January 7, 2021

    RICHARD-ALLAN SHEET CLIP

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

    KODAK SURECELL(TM) HCG URINE TEST KIT/MODIFICATION

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·March 10, 2021

    OPTISENSE LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC.·Product code NVN·December 26, 2018

    GLIDEWIRE GT

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·March 30, 2026

    PULSE GEN MODEL 105

    FDA Adverse Event
    Death ·CYBERONICS, INC.·Product code LYJ·February 11, 2013

    TENDRIL SDX

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 10, 2011

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 24, 2014

    GLIDEWIRE GT

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 29, 2026

    TITANIUM HEXALOBE SET SCREW, 8.5MM

    FDA Adverse Event
    Malfunction ·ALPHATEC SPINE INC·Product code KWP·July 23, 2013

    RADIFOCUS GLIDEWIRE

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·November 26, 2025

    TERUMO RADIFOCUS GUIDE WIRE

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 3, 2025

    GLIDEWIRE GT

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·February 21, 2018

    PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701

    FDA Recall
    Open, Classified ·VANTIVE US HEALTHCARE LLC·Product code KDI·July 28, 2025

    PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701

    FDA Enforcement
    Class II ·Ongoing·VANTIVE US HEALTHCARE LLC·September 3, 2025