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

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    UREA NITROGEN TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACME Class B 21 - 36 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588250021·ACME Class B 21 - 36 Metal

    MULTI FA

    FDA UDI
    Gc Orthodontics America Inc.·D78892500200001·MULTI FA SHORT (LEFT & RIGHT)

    STERILE GAUZE PK STRIPS SAT W/CARR GEL WOUND DRESS

    FDA 510(k)
    FDA Unclassified ·Unknown

    SINGLE USE MANUAL RESUSCITATORS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    N/A

    FDA UDI
    Zimmer, Inc.·00889024067165·

    LAPRO-CLIP

    FDA Adverse Event
    Malfunction ·COVIDIEN LP LLC NORTH HAVEN·Product code GCJ·June 4, 2025

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 18, 2014

    XIA3 TITANIUM ROD DIAM 6MM CP TI L 120MM

    FDA Adverse Event
    Injury ·STRYKER SPINE BORDEAUX·Product code NKB·January 17, 2013

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 14, 2010

    BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe is used in conjunction with an epidural needle with the purpose of finding the epidural space.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·October 2, 2013

    MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts and assemble care plans, order diagnostic tests, and prescribe medications. It also lets users import, view, annotate, manipulate, enhance, manage, and archive images.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IYE·September 18, 2012

    Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ The intended use of Sequencer (generically referred to as a verification system) is to assist in the process of process of patient treatment on a radiotherapy treatment machine. It gives the capability to notify users of actions that need to take place prior to treatment, to display reference images for set up purposes and to auto setup the machine to predefined settings.

    FDA Recall
    Terminated ·Impac Medical Systems Inc·Product code IYE·March 10, 2011

    SEQUENCER component of MOSAIQ versions 1.30 (all builds), 1.40 (all builds), 1.50 (all builds), 1.60 (all builds), and 2.0 (all builds). Manufactured by IMPAC Medical Systems, Inc. Sunnyvale, CA. The intended use of SEQUENCER (a verification system) is to assist in the process of patient treatment on a radiotherapy treatment machine. SEQUENCER provides the capability to notify the users of actions that need to take place prior to treatment, to display reference images for set up purposes, and to auto setup the machine to predefined settings. Actual settings are read from the treatment machine, via the machine's communication interface, and compared to the predefined values. If a mismatch occurs between the planned values and the actual machine settings, treatment is prohibited. At appropriate times during the treatment, the actual delivered values are recorded to provide treatment tracking. Treatments are initiated by the operator, via the machine control system, only after the user has verified that the treatment setup is correct. SEQUENCER does not bypass any checks put in place by the machine's control system.

    FDA Recall
    Terminated ·Impac Medical Systems Inc·Product code IYE·July 17, 2009