BEUDAMED
    23 results · 26ms · Sources: EU EUDAMED, US FDA

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    MULTIFIX P KNOTLESS FIXATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALN Optional Vena Cava Filter - Jugular Approach

    FDA UDI
    A.L.N.·03760017680011·The device is an Optional Vena Cava Filter - Ju...

    ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART

    FDA 510(k)
    FDA Class 2 ·Radiology

    NOVOSYN VIOLET 6/0(0.7)20CM 2XVLM8 (M

    FDA Adverse Event
    Injury ·B. BRAUN SURGICAL, S.A.U.·Product code GAM·November 29, 2021

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 20, 2024

    ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TM ANKLE PROLONG TIBIAL INSERT SZ 6 +2

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSN·August 14, 2018

    TM ANKLE TIBIAL INSERT COMPONENT SIZE 4

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code ITW·August 9, 2018

    ERBE ICC 200

    FDA Adverse Event
    Injury ·ERBE USA, INC.·Product code GEI·May 14, 2013

    ZIMMER M/L TAPER MODULAR FEMORAL STEM

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code LPH·June 7, 2011

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 15, 2008

    TRABECULAR METAL TOTAL ANKLE TIBIAL BASE COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018

    TRABECULAR METAL TOTAL ANKLE TIBIAL INSERT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018

    TRABECULAR METAL TOTAL ANKLE TALAR COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018

    HANG&GO HT BASIC

    FDA Adverse Event
    Malfunction ·RAND S.R.L.·Product code LGZ·May 15, 2017

    NOVOSYN 6/0

    FDA Adverse Event
    Injury ·B. BRAUN SURGICAL, S.A.·Product code GAM·July 21, 2021

    NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images.

    FDA Enforcement
    Class III ·Terminated·Nidek, Inc.·January 8, 2020

    MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software

    FDA Enforcement
    Class II ·Ongoing·Auris Health, Inc·February 25, 2026

    Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.

    FDA Enforcement
    Class II ·Ongoing·AURIS HEALTH INC·October 16, 2024