BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Preat

    FDA UDI
    Preat Corporation·00842092170670·ASC NobelActive™/Conical-compatible RP Non-Enga...

    PowerMIdline

    FDA UDI
    Bard Access Systems, Inc.·00801741201028·Catheter Placement Kit

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964008885·Endo Carry-On Procedure Kit

    Epredia

    FDA UDI
    RICHARD-ALLAN SCIENTIFIC COMPANY·00673693214339·Cassettes are designed to contain incised tissu...

    COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ACCU-CHEK COMPLETE METER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FATHOM GUIDEWIRE

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - FREMONT·Product code DQX·June 16, 2011

    TUFF IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·November 12, 2024

    INFINION? PRO

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code QRB·September 3, 2025

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Death ·W.L. GORE & ASSOCIATES·Product code MIH·March 6, 2013

    CRYSTALENS AO

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code NAA·February 18, 2011

    VALVE AORTIC EDWARDS PERICARDIAL 2800 23MM

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES, LLC·Product code LWR·February 21, 2008

    FATHOM GUIDEWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·February 23, 2010

    FATHOM GUIDEWIRE

    FDA Adverse Event
    Injury ·SALT LAKE CITY·Product code DQX·February 23, 2010

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

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

    STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·April 10, 2013

    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

    Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420

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