BEUDAMED
    11 results · 26ms · Sources: EU EUDAMED, US FDA

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    G.E.V. DISPOSABLE SCALPELS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Tranquil-L™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788228930·Curette #4 Ang, 9" Handle

    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CORDIS DOW C-DAK 1.3MRC ARTIF. KIDNEY

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

    TRUCLEAR

    FDA Adverse Event
    Malfunction ·COVIDIEN MANSFIELD·Product code HIH·May 29, 2025

    JAGWIRE¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code EZB·November 7, 2012

    SYMBIQ DCHANNEL 3.01

    FDA Adverse Event
    Malfunction ·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·February 5, 2014

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·September 1, 2010

    Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump -- Class 2 medical device -- SIGMA LLC, Medina, NY 14103 Product Usage: The Spectrum Infusion Pump is intended to be used for the controlled administration of intravenous fluids. These fluids may include blood, blood products or mixtures of pharmaceutical drugs for required patient therapy. The Spectrum is used in conjunction with legally marked intravenous administration sets and medications provided by the user. The Master Drug Library is a software package that will add additional features to the Spectrum Infusion Pump. The Master Drug Library will permit electronic communications with the Spectrum pump and other external peripheral devices. The intended use of the Spectrum pump includes common drug error prevention, through the stand alone settings features of the pump. This includes drug parameter limits and associated drug name identification. With the Master Drug Library, the intended use is to reduce user errors associated with drug selection, drug dose rates, drug dose concentrations, and patient identification associated with the prescribed drug.

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code FRN·July 6, 2011

    ACCOLADE SR SL MRI (Model L310)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012