BEUDAMED
    9 results · 24ms · 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.
    Filters Regulation: Us FDA ×

    CarboClear® Pedicle Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OLYMPUS IGM REAGENT

    FDA 510(k)
    FDA Class 2 ·Immunology

    FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AMISTEM H COATED STD STEM SIZE 1

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 23, 2021

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 17, 2013

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·July 23, 2011

    CARDIOSEAL CS-23-VSD

    FDA Adverse Event
    Other ·NMT MEDICAL, INC.·Product code MLV·September 22, 2008

    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

    FDA Enforcement
    Class III ·Terminated·Illumina Inc·December 31, 2014

    Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·October 31, 2018