BEUDAMED
    16 results · 27ms · Sources: EU EUDAMED, US FDA

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    PRIMED TRACHEOSTOMY TUBES (MULTIPLE)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ArgenIs

    FDA UDI
    ARGEN CORPORATION, THE·D818120079·Dental prosthesis/implant abutment screw A non...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450190777·

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197411448·Sealy Plastic Scissors curved...

    DIGITAL ULTRASOUND SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    BLADEWORKS MICROKERATOME BLADE, MODEL 7061

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 16, 2025

    NA

    FDA UDI
    Zimmer, Inc.·00889024186781·

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    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

    R SERIES DEFIBRILALTOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORP·Product code MKJ·May 26, 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

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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