BEUDAMED
    20 results · 22ms · Sources: EU EUDAMED, US FDA

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    F&P Eson 2 Nasal Mask

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ESON 2 NASAL MASK

    FDA Adverse Event
    Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·August 14, 2019

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707014973·CALIBRA 1ST MOL BANDS W/G8325-03 n.UL 5

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100325·INFANT WIRE SPECULUM 4MM BLADE

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111084881·SKLARCUT OP SCIS STR SB 5 1/2

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383507547·Gutta Percha Points is used to root canal filin...

    REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUGMENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALTUM ANTERIOR CERVICAL PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BELLATEK® ABUTMENT TSV 3.5MM

    FDA Adverse Event
    Malfunction ·ZIMVIE US CORP LLC·Product code NHA·March 3, 2026

    BELLATEK ABUTMENT TSV 4.5MM

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code NHA·February 5, 2021

    ABUTMENT, PATIENT SPECIFIC, TITANIUM

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·June 26, 2017

    BELLATEK ABUTMENT TSV 4.5MM

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·October 30, 2020

    BELLATEK ABUTMENT TSV 4.5MM

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·October 30, 2020

    FORTIFY ASSURA DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·October 8, 2014

    ATTAIN ABILITY STRAIGHT

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·June 8, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 21, 2011

    FUSION ENT NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·February 2, 2021

    SCANLAN Premier Jacobson Micro Scissors, spring style, round handle, V-neck, 125-degree angled micro fine blades, 8'', 20 cm. Catalog no. 7007-499-8

    FDA Recall
    Terminated ·Product code DXY·July 27, 2005

    ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021