BEUDAMED
    14 results · 28ms · Sources: EU EUDAMED, US FDA

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    Zeramex P6 Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    Metra Unitized Pack - ZLB

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588130439·Metra Unitized Pack - ZLB

    SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP

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

    COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    POLYFORM SYNTHETIC MESH

    FDA Adverse Event
    Injury ·PROXY BIOMEDICAL LTD.·Product code FTL·May 28, 2013

    ADVANTAGE FIT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 15, 2011

    CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code KRH·September 12, 2008

    CHROMID STREPTO B AGAR

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code PQZ·November 1, 2017

    CHROMID STREPTO B AGAR

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code PQZ·November 1, 2017

    INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·July 4, 2019

    Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.

    FDA Enforcement
    Class II ·Terminated·Luminex Corporation·December 2, 2020

    Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.

    FDA Enforcement
    Class II ·Terminated·Luminex Corporation·December 2, 2020

    Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.

    FDA Enforcement
    Class II ·Terminated·Luminex Corporation·August 19, 2020

    Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.

    FDA Enforcement
    Class II ·Terminated·Luminex Corporation·August 19, 2020