BEUDAMED
    20 results · 28ms · Sources: EU EUDAMED, US FDA

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    2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517287649·CoRoent® LC Ti, 10x11x25mm 8°

    SAV

    FDA UDI
    Diversified Products, Inc.·00842894116906·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450160121·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450160107·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450150412·

    MYSTIQUE® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K110152101·MYSTIQUE® MB RT RX 022 U 5-5 CS HK

    UNKNOWN

    FDA Adverse Event
    Injury ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMF·October 15, 2015

    INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    VISION SCIENCES FLEXIBLE ENT SCOPE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    BD INSULIN PEN NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·May 13, 2013

    AFFINITY 3

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code HDD·May 19, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 14, 2008

    UNSPECIFIED BD WINGSET

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code JKA·December 15, 2020

    ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·January 24, 2024

    Spectral CT. Computed tomography X-ray system.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 2, 2025

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018