BEUDAMED
    14 results · 26ms · Sources: EU EUDAMED, US FDA

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    SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Good Sense

    FDA UDI
    GEISS, DESTIN & DUNN, INC·00846036006742·

    ACUMED

    FDA UDI
    Acumed LLC·10806378043956·Acu-Loc® 2 System Case Base

    PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NAV 4.5MM TAP (CANNULATED)

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code OLO·May 8, 2014

    RESERVOIR 1.8 ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 22, 2012

    5MM, 33CM PERITONEAL SCISSORS

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code GEI·August 4, 2010

    Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food particles from between the teeth and below the gum line. The power handle can also function as a rechargeable battery powered mechanical toothbrush.

    FDA Recall
    Terminated ·Water Pik, Inc.·Product code JET·July 2, 2018

    Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.

    FDA Enforcement
    Class II ·Terminated·BioHorizons Implant Systems Inc·December 26, 2012

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·November 12, 2014

    UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI 600i systems are in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·November 12, 2014