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

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    EDTA ROOT CANAL CLEANSER

    FDA 510(k)
    FDA Unclassified ·Unknown

    Premier Excavators

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783008388·Excavator DE_OC 12(C17)

    GE

    FDA UDI
    Conmed Corporation·10653405002666·ECR LEADWIRES

    SCANLAN® Needle Holders

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159003260·Microvascular Needle Holder Diamond Dust™ Jaw

    S57D DIGITAL OPERATING ROOM CAMERA

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PSN HEMODIALYZER, MODELS PSN 170, PSN 210

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BD PRESET¿ ECLIPSE¿

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 8, 2024

    BD PRESET¿ ECLIPSE¿

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·July 10, 2024

    INFINION? PRO

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·July 11, 2025

    ORACLE LATERAL QUICK

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code LXH·February 28, 2013

    SYNCHRON LX® 20 PRO CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·March 1, 2011

    REMSTAR HEATED HUMIDIFIER

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code BTT·February 21, 2008

    PULSE GENERATOR, PERMANENT, IMPLANTABLE

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code NVZ·April 21, 2016

    MEDTRONIC LEAD

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DXY·April 21, 2016

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    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

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

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