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

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    IMMPULSE PHENOBARBITAL ASSAY REAGENTS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ADVIA® Chemistry LP(A) Lipoprotein(a) Reagents

    FDA UDI
    Siemens Healthcare Diagnostics Inc.·00630414558080·Lipoprotein - ADVIA Chem. - RGT - 200 tests

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867125674·HEADLESS COMPRES SCRW 2.5X28MM

    TISSUE SITE MARKING SYSTEM

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

    PFIZONIC 150 ULTRASOUND SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPRINT QUATTRO SECURE

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

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·December 10, 2012

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 23, 2015

    2.0X230MM THRD GUIDE WIRE STE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LXH·March 26, 2018

    THREADED GUIDE WIRE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LXH·March 26, 2018

    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

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021