BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    IntraSight

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690194972·AK3 Patella Instruments Pan

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306821707·Laryngeal Mirror - ##000

    Ophthalmic Retractor

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101070·WALTON CONJUNCTIVA RETRACTOR

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690195085·AK3 Patella Instruments Pan Insert

    KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MODIFIED STRAIGHT FIRE LASER FIBER

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

    MONACO

    FDA Adverse Event
    Malfunction ·ELEKTA INC.·Product code MUJ·July 28, 2021

    IDENTITY ADX XL DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·January 11, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 18, 2013

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSTION CORP·Product code FPA·June 29, 2011

    MONACO

    FDA Adverse Event
    Malfunction ·ELEKTA INC·Product code MUJ·August 25, 2021

    SenTec Standard Starter Set with and without Service Gas (2 changers each) - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.

    FDA Enforcement
    Class II ·Terminated·SenTec AG·August 14, 2019

    Vysis LSI p16 (9p21)/CEP 9 (9p11-q11) Dual Color Probe Set; a locus specific identifier DNA probe consisting of a mixture of the LSI p16 probe labeled with a SpectrumOrange and the CEP 9 probe labeled with a SpectrumGreen fluorophore, accompanied with LSI/WCP Hybridization Buffer; 20 evaluations; Vysis Inc., Downers Grove, IL 60515; order number 32-190078

    FDA Recall
    Terminated ·Abbott Molecular·Product code MAO·October 28, 2005