BEUDAMED
    13 results · 30ms · Sources: EU EUDAMED, US FDA

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    Qraypen

    FDA 510(k)
    FDA Class 1 ·Dental

    SILICONE MAT

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896019348·SILICONE MAT LOWER TRAY

    DREAMSTATION AUTO CPAP

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·August 3, 2022

    NEO MAPCATH SENSOR STYLET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ECO-S

    FDA 510(k)
    FDA Class 2 ·Dental

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·April 22, 2003

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·March 14, 2019

    UNKNOWN SCREW

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code PAO·February 4, 2015

    8 CM ANGLE ATTACHMENT QD8

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 17, 2014

    HOLDER F/SET F/BONEGRAFT-HARVEST INCL NO

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code LXH·June 21, 2013

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·July 28, 2011

    Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

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