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

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    C2 NERVEMONITOR SYSTEM WITH ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Neurology

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964112409·Custom Procedure Kit

    RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS

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

    WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 13, 2024

    GALILEO

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·June 6, 2008

    PLMA DVC V11.51 1 N

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 7, 2013

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Injury ·BECKMAN COULTER, INC.·Product code DHA·June 2, 2011

    BRAVO

    FDA Adverse Event
    Malfunction ·ARIZONA DEVICE MANUFACTURING·Product code FFT·August 13, 2008

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021