BEUDAMED
    10 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    HEMAFLUOR REAGENT KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Ceramco® iC

    FDA UDI
    Dentsply International Inc.·D00148603090·

    Shoreline ACS

    FDA UDI
    Seaspine Orthopedics Corporation·10889981127336·18x15x9mm, 7 Degree Trial

    Neurosoft TMS

    FDA 510(k)
    FDA Class 2 ·Neurology

    AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·June 10, 2014

    SETROX S 45

    FDA Adverse Event
    Other ·BIOTRONIK SE AND CO. KG·Product code NVZ·November 21, 2012

    FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNS·September 23, 2010

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020

    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