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    ONY BIOTECH INC.

    FDA registration
    ONY BIOTECH INC.·1 product·🇺🇸 United States

    ONIS-PACS

    FDA 510(k)
    FDA Class 2 ·Radiology

    AerVia Neonatal Supraglottic Airway Device, Small, <1000g

    FDA UDI
    ONY Biotech Inc.·00361938122012·6-Pack of AerVia Neonatal Supraglottic Airway D...

    AerVia Neonatal Supraglottic Airway Device, X-Large, 3500-5000g

    FDA UDI
    ONY Biotech Inc.·00361938122043·6-Pack of AerVia Neonatal Supraglottic Airway D...

    AerVia Neonatal Supraglottic Airway Device, Large, 2000-3500g

    FDA UDI
    ONY Biotech Inc.·00361938122036·6-Pack of AerVia Neonatal Supraglottic Airway D...

    AerVia Neonatal Supraglottic Airway Device, Variety

    FDA UDI
    ONY Biotech Inc.·00361938122050·AerVia Neonatal Supraglottic Airway Device, Var...

    AerVia Neonatal Supraglottic Airway Device, Medium, 1000-2000g

    FDA UDI
    ONY Biotech Inc.·00361938122029·6-Pack of AerVia Neonatal Supraglottic Airway D...

    UNKNOWN

    FDA Adverse Event
    Injury ·JOURNEY ONI·Product code JWH·October 9, 2009

    ORTHONE

    FDA Adverse Event
    Injury ·ONI, INC.·Product code LNH·August 1, 2002

    ORTHONE

    FDA Adverse Event
    Injury ·ONI, INC.·Product code LNH·June 28, 2002

    ROCHESTER MEC POP-ON I 30BX

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON) -1018233·Product code NNX·April 2, 2020

    ROCHESTER MEC POP-ON I 100BX

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code NNX·July 9, 2018

    ROCHESTER MEC POP-ON I 30BX

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code NNX·February 23, 2018

    ORTHONE

    FDA Adverse Event
    Other ·ONI, MEDICAL SYSTEMS INC.·Product code LNH·March 19, 2004

    ARCHITECT C8000 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·May 1, 2012

    ADAPTER FOR FIXATION OF UNIVERSAL TRACKER TO MAYFIELD CLAMP

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP·Product code HAW·August 21, 2023

    HAMILTON-T1

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·April 9, 2024

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·March 19, 2020

    VISIA AF XT VR

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LWS·March 3, 2021

    EPIQ 7C

    FDA Adverse Event
    Malfunction ·PHILIPS ULTRASOUND·Product code IYN·April 25, 2022