BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    CONDUCTIVE GEL FOR ULTRASOUND

    FDA 510(k)
    FDA Class 2 ·Neurology

    Varisoft™

    FDA UDI
    Unomedical A/S·05705244018846·Single use infusion set for subcutaneous infusi...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450255476·

    Patient Hose, 1.2 meter Bayonet, Black, RDT

    FDA UDI
    SUNTECH MEDICAL, INC.·10840935110507·

    STAR™

    FDA UDI
    Stryker GmbH·00886385019468·Trial S.T.A.R. P.E. Core 12mm

    BD PLASTIC NON-STERILE 5ML LUER-LOK¿ TIP SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 20, 2017

    ONYX

    FDA Adverse Event
    Malfunction ·EV3 NEUROVASCULAR·Product code MFE·November 4, 2009

    STEROTACTIC LOCALIZATION DEVICE (SLD)

    FDA 510(k)
    FDA Class 2 ·Radiology

    PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318

    FDA 510(k)
    FDA Class 2 ·General Hospital

    IN TOUCH ZU

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 13, 2013

    UNKNOWN DEPUY DURALOC 28X52 10D LINER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·February 16, 2011

    COVIDIEN/KENDALL

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code LZH·February 21, 2008

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 21, 2025

    SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code LOZ·December 11, 2014

    SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code LOZ·December 11, 2014

    Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971

    FDA Enforcement
    Class II ·Terminated·ArthroCare Corporation·September 30, 2020

    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 Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

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