BEUDAMED
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    MOSAIQ ONCOLOGY INFORMATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ArgenIs

    FDA UDI
    ARGEN CORPORATION, THE·D818120067·Dental prosthesis/implant abutment screw A non...

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036031299·

    NA

    FDA UDI
    STRYKER CORPORATION·04546540078643·2.1mm Cross Cut Fissure Round End

    GYRUS ENT SOMNOPLASTY GENERATOR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    NA

    FDA UDI
    Zimmer, Inc.·00889024186620·

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·February 6, 2019

    CADD LEGACY PUMP

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·October 13, 2021

    DEPUY ASR XL FEM IMP SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 20, 2013

    NEXGEN LCCK ARTICULAR SURFACE

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

    FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code JCT·August 15, 2008

    VERSE POLY DRIVER SHAFT NAV

    FDA Adverse Event
    Malfunction ·DEPUY SPINE INC·Product code OLO·April 29, 2022

    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

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 30, 2025