BEUDAMED
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    OPTIMUS CMF SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221045133·Unitek(TM) Molar Band General Purpose Wide Regu...

    HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12

    FDA 510(k)
    FDA Unclassified ·Unknown

    ULTRA DCI MODEL 5000

    FDA 510(k)
    FDA Class 2 ·Radiology

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 10, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 20, 2011

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008

    BD PHOENIX¿ NMIC-306

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·December 10, 2024

    Artis zeego, Model Number 10280959

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

    Artis zeego, Model Number 10280959

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 10, 2014

    Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 12, 2015

    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