BEUDAMED
    12 results · 17ms · Sources: EU EUDAMED, US FDA

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    QUADRA-TITER I.D.

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Shoreline ACS

    FDA UDI
    Seaspine Orthopedics Corporation·10889981127244·16x14x8mm, 7 Degree Trial

    CAREO SAFETY SYRINGE 1CC/ML, MODELS CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C,CA0104-C,CA0194-C,CA0184-C,

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NILE Alternative Fixation Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CAPSUREFIX NOVUS

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

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·November 2, 2012

    GENDER SOLUTION PFJ MILLING BURR

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code LXH·September 21, 2010

    Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319

    FDA Recall
    Open, Classified ·Covidien LLC·Product code OLW·July 26, 2018

    Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319

    FDA Enforcement
    Class II ·Ongoing·Covidien LLC·September 5, 2018

    Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·October 1, 2025

    Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262

    FDA Enforcement
    Class II ·Terminated·Isopure Corp·September 21, 2022

    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