BEUDAMED
    380 results · 32ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    CIRCUL8 PRO

    FDA Adverse Event
    Injury ·ORTHO8 INC.·Product code JOW·March 23, 2022

    EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile

    FDA Recall
    Open, Classified ·Ortho8, Inc.·Product code JOW·July 9, 2021

    CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,

    FDA Recall
    Open, Classified ·Ortho8, Inc.·Product code JOW·July 9, 2021

    CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,

    FDA Enforcement
    Class II ·Ongoing·Ortho8, Inc.·August 25, 2021

    EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile

    FDA Enforcement
    Class II ·Ongoing·Ortho8, Inc.·August 25, 2021

    VIVID Aligners

    FDA UDI
    Ortho Dent Laboratory Inc·00860011027201·Sequential aligner

    RMR ORTHO, Inc

    FDA registration
    RMR ORTHO, Inc·1 product·🇺🇸 United States

    ALM ORTHO, INC.

    FDA registration
    ALM ORTHO, INC.·7 products·🇺🇸 United States

    Osskin Ortho Inc.

    FDA registration
    Osskin Ortho Inc.·3 products·🇨🇦 Canada

    DIMENSION ORTHO Inc.

    FDA registration
    DIMENSION ORTHO Inc.·1 product·🇺🇸 United States

    Native

    FDA UDI
    INS ORTHO INC.·00850075111107·Spear Passer Needle 5-Pack

    Smile Shapers

    FDA UDI
    Phase Ortho, Inc.·00860006274337·Smile Shapers Retainer

    Native

    FDA UDI
    INS ORTHO INC.·00850075111077·Spear Passer Suture Passer

    Native

    FDA UDI
    INS ORTHO INC.·00850075111008·Root Finder Guide

    Smile Shapers

    FDA UDI
    Phase Ortho, Inc.·00860006274320·Smile Shapers Clear Aligner - Zendura

    Native

    FDA UDI
    INS ORTHO INC.·00850075111039·Nitinol Wire Loop

    Phase Ortho Private Label

    FDA UDI
    Phase Ortho, Inc.·00860006274344·Phase Ortho Private Label Clear Aligner - Tempo...

    Tru-Smile

    FDA UDI
    Phase Ortho, Inc.·00860006274375·Tru-Smile Retainers

    Native

    FDA UDI
    INS ORTHO INC.·00850075111046·Nitinol Wire Loop 5-Pack

    Tru-Smile

    FDA UDI
    Phase Ortho, Inc.·00860006274368·Tru-Smile Clear Aligner