BEUDAMED
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    DISPOSABLE CB-PE MICROKERATOME BLADES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Temp Esthetic

    FDA UDI
    Harvest Dental Products, LLC·D87010038201·Temp Esthetic Disc, 98.5 X 20mm, Shade A2

    SCANLAN® Legacy Forceps

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159034141·Bayonet Scan-II Handle, 1x2 Tips

    MIO¿ ADVANCE

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·May 8, 2025

    CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X30

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·November 23, 2021

    BD NEXIVA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.·Product code FOZ·March 7, 2013

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·February 7, 2011

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·February 26, 2008

    HAND PIECE FOR BATTERY POWERED DRIVER

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HXX·March 25, 2015

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

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