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

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    INFX-8000V WITH

    FDA 510(k)
    FDA Class 2 ·Radiology

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486018085·FEMORAL HEADED PIN PUSHER

    Chemosite

    FDA UDI
    Covidien LP·10884521099036·Line Extension Set

    ArgenIs

    FDA UDI
    ARGEN CORPORATION, THE·D818120073·Dental prosthesis/implant abutment screw A non...

    MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDICAL ADMINISTRATOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    Widex

    FDA UDI
    Widex A/S·05706069818123·Widex UNIQUE U-FP (Titan grey ) 220, Telecoil, ...

    NA

    FDA UDI
    Zimmer, Inc.·00889024186767·

    Widex

    FDA UDI
    Widex A/S·05706069817188·Widex UNIQUE U-FA (Titan grey ) 220, Telecoil, ...

    Widex

    FDA UDI
    Widex A/S·05706069817775·Widex UNIQUE U-FM (Titan grey ) 220, RC coil

    V.A.C. FREEDOM THERAPY SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·February 15, 2021

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 20, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 25, 2014

    ZIMMER TM REVERSE SHOULDER GLENOSPHERE

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

    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

    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