BEUDAMED
    13 results · 27ms · 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.

    THE DENVER CAUTERY

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

    16PW - Class A Burn 21 - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588620626·16PW - Class A Burn 21 - Poly White

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123281·K-WIRE - DOUBLE TROCAR 2.0mm DIA x 150mm

    APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER

    FDA 510(k)
    FDA Class 2 ·Immunology

    IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    THERMAL SENSORY ANALYZER (TSA-II)

    FDA Adverse Event
    Injury ·MEDOC LTD., ADVANCED MEDICAL SURGERY MEDISCENSE USA·Product code LQW·December 26, 2019

    SPINAL ANES/EPIDURAL CAT H KIT

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code CAZ·January 15, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010

    INCEPTA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 9, 2014

    REAGENT RED BLOOD CELLS BIOTESTCELL-I11

    FDA Adverse Event
    Malfunction ·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code KSZ·November 11, 2019

    QSENSE CPM THERMAL SENSORY ANALYZER 2001

    FDA Adverse Event
    Malfunction ·MEDOC LTD, ADVANCED MEDICAL SYSTEM·Product code LQW·April 19, 2022

    ACCESS 2 IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Injury ·BECKMAN COULTER·Product code JJE·February 3, 2021

    Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK

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