BEUDAMED
    11 results · 34ms · Sources: EU EUDAMED, US FDA

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    URINALYSIS REAGENT STRIPS (10 PARAMETERS)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PHILIPS 45 SERIES

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    REDOX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·February 19, 2016

    TAPERLOC POR LAT FMRL 12.5X145

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code JDI·August 20, 2021

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·April 9, 2015

    ALIGN S SUPRAPBUBIC URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BARD SHANNON LTD·Product code OTN·March 4, 2013

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·February 11, 2011

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·August 8, 2014

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024