BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777594·LUMBAMED BASIC DORSAL STAY WM SILVER II

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777440·LUMBAMED PLUS FLEX PAD WM SILVER II

    FEIYUE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    StaClear Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    REZUM

    FDA Adverse Event
    Injury ·MEDPLAST MEDICAL, INC.·Product code KNS·March 1, 2019

    ADAPTA

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code NVZ·March 23, 2021

    RUSCH LASERTUBUS ENDOTRACHEAL TUBE 6MM

    FDA Adverse Event
    Malfunction ·TELEFLEX·Product code BTR·October 29, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    1.4MM X 12.8MM FLUTED ROUTER

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·August 11, 2014

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·September 2, 2016

    Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.

    FDA Enforcement
    Class II ·Terminated·Lumenis Limited·May 6, 2015

    Nussloch GmbH ASP6025 Tissue Processor

    FDA Enforcement
    Class II ·Ongoing·Leica Microsystems, Inc.·July 12, 2017

    Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation, dehydration, infiltration with intermedium, and the paraffin infiltration of histological tissue specimens.

    FDA Enforcement
    Class II ·Terminated·Leica Microsystems, Inc.·August 7, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013