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    Semi-Kinetics, Inc. OBO SK Global Trading Inc.

    FDA registration
    Semi-Kinetics, Inc. OBO SK Global Trading Inc.·2 products·🇺🇸 United States

    V200 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC·Product code CBK·October 8, 2020

    O.B. ORIGINAL TAMPONS - APPLICATOR AND NON-APPLICATOR VERSIONS

    FDA Adverse Event
    Injury ·EDGEWELL PERSONAL CARE·Product code HEB·April 25, 2022

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    FDA Adverse Event
    Malfunction ·CONCORD MANUFACTURING·Product code FKX·March 25, 2022

    TOMOGRAPHY, OPTICAL COHERENCE

    FDA Adverse Event
    Injury ·CARL ZEISS MEDITEC AG (JENA)·Product code OBO·April 16, 2021

    PLEX ELITE 9000 SS-OCT

    FDA Adverse Event
    Malfunction ·CARL ZEISS MEDITEC, INC.·Product code OBO·October 16, 2018

    3D OCT-1 MAESTRO

    FDA Adverse Event
    Injury ·TOPCON CORPORATION·Product code OBO·April 15, 2024

    DRI OCT TRITON (PLUS)

    FDA Adverse Event
    Injury ·TOPCON CORPORATION·Product code OBO·August 16, 2023

    DRI OCT TRITON (PLUS)

    FDA Adverse Event
    Injury ·TOPCON CORPORATION·Product code OBO·August 16, 2023

    3D OCT-1 MAESTRO

    FDA Adverse Event
    Injury ·TOPCON CORPORATION·Product code OBO·April 15, 2024

    CIRRUS HD-OCT 6000

    FDA Adverse Event
    Malfunction ·CARL ZEISS MEDITEC, INC.·Product code OBO·April 4, 2023

    ZEISS CIRRUS HD-OCT 4000 RETINA TOMOGRAPHER

    FDA Adverse Event
    Malfunction ·CARL ZEISS MEDITEC, INC·Product code OBO·September 17, 2024

    RESCAN 700

    FDA Adverse Event
    Injury ·CARL ZEISS MEDITEC AG (OBERKOCHEN)·Product code OBO·June 24, 2025

    RESCAN 700

    FDA Adverse Event
    Injury ·CARL ZEISS MEDITEC AG·Product code OBO·April 2, 2025

    RESCAN 700

    FDA Adverse Event
    Injury ·CARL ZEISS MEDITEC AG·Product code OBO·April 2, 2025

    CALLISTO EYE

    FDA Adverse Event
    Injury ·CARL ZEISS MEDITEC AG (MUNICH)·Product code OBO·June 24, 2025

    ZEISS CIRRUS

    FDA Adverse Event
    Malfunction ·ZEISS·Product code OBO·September 13, 2013

    SYNERGEYES MULTIFOCAL HYBRID CONTACT LENS

    FDA Adverse Event
    Injury ·SYNERGEYES, INC.·Product code OBO·July 2, 2013

    CALLISTO

    FDA Adverse Event
    Malfunction ·CARL ZEISS MEDITEC AG·Product code OBO·June 2, 2016

    The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a non- contact, high resolution, wide field of view tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dimensional imaging of posterior ocular structures. The device is indicated for visualizing posterior ocular structures including, but not limited to, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, optic nerve head, vitreous and choroid. The PLEX Elite SS-OCT angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·January 8, 2020