BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    APEX FIXATION PINS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040059897·Premium Needles 27Ga Short

    Z-Series Size 1 Vertical Bitewing ROSE Bite Block 3-Pack

    FDA UDI
    CLIKTECH LLC·00856200001886·Z-Series Size 1 Vertical Bitewing ROSE Bite Blo...

    AUTOSOFT XC

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·October 24, 2024

    AUTOSOFT XC

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·October 24, 2024

    AUTOSOFT XC

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·October 24, 2024

    SPIROL EPIDURAL CATHETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 12, 2013

    PUMP,COLLEAGUE CXE SINGLECHANNEL COLOUR FRENCH LOANER

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 25, 2011

    FOUNDATION KNEE SYSTEM

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code HTG·February 25, 2008

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    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

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

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