BEUDAMED
    18 results · 25ms · Sources: EU EUDAMED, US FDA

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    Xenco Medical Cervical Interbody System (Argus)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517637987·CoRoent Ant TLIF PEEK, 15x12x30mm 12°

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04064984699540·GENUMEDI PSS BLUE SIZE II

    n.a.

    FDA UDI
    Karl Storz GmbH & Co. KG·04048551057599·Ear Hook, without ball end, size 2

    2.0 LACTOSORB SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036055042·

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690124245·Modular Offset Stem 13mm x 100mm x 2mm

    TIP FOR DHS®/DCS® IMPACTOR (338.28)

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code HWA·August 17, 2017

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·December 8, 2022

    PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FREESTYLE LIBRE 2 PLUS

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code QBJ·May 12, 2026

    TIP FOR DHS®/DCS® IMPACTOR (338.28)

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HWA·August 4, 2017

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·June 7, 2013

    XIA TITANIUM 4.5 BLOCKER

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code NKB·June 23, 2011

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 2, 2014

    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

    BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Co.·October 17, 2018

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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