BEUDAMED
    13 results · 30ms · Sources: EU EUDAMED, US FDA

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    E-CUBE i7

    FDA 510(k)
    FDA Class 2 ·Radiology

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180164062·Metz. Scissors Single Action Cystoscopy Flexib...

    Prime Medical LLC

    FDA UDI
    Prime Medical LLC·00850055249295·PrimePadPlus-K15-3422

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·October 9, 2017

    SAFIRE

    FDA 510(k)
    FDA Class 2 ·Radiology

    POPMESH

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., HU·Product code KWP·October 17, 2025

    CD HORIZON BALLAST SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NKB·December 9, 2019

    SELECTSECURE

    FDA Adverse Event
    Injury ·MPRI·Product code NVY·June 8, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 21, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·September 5, 2008

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    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