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

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    APLICARE SKIN PROTECTANT PREP PAD

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MEAS 4400 Series Temperature Probe

    FDA UDI
    MEASUREMENT SPECIALTIES, INC.·H29744680·Foley Catheter Temperature Probe, 18 FR

    FUSION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    truFreeze System

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

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·June 7, 2024

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 8, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 13, 2014

    TRILOGY SHELL WITH CLUSTER HOLES

    FDA Adverse Event
    Malfunction ·ZIMMER·Product code LPH·November 28, 2012

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015

    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