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    NB Regular Kit

    FDA UDI
    ARUM DENTISTRY Co., Ltd.·08800055791210·

    MEDPLUS TIBBİ CİHAZLAR SAĞLIK MALZ. REK. ORG. SAN. VE TİC. LTD. ŞTİ.

    Manufacturer
    🇹🇷 Türkiye

    Formthotics

    FDA UDI
    FOOT SCIENCE INTERNATIONAL LIMITED·09419430004747·Express Kit 3/4 Length Red - K

    Formthotics

    FDA UDI
    FOOT SCIENCE INTERNATIONAL LIMITED·09419430004921·Express Kit Full Length Red - K

    20DP VENTED IV DC 15 MICRON

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·August 7, 2023

    Wesper Lab

    FDA UDI
    Tatch Inc.·00860007837029·Wesper Lab (“the device”) is a digital recordin...

    Wesper Lab

    FDA UDI
    Tatch Inc.·00860007837012·Wesper Lab (“the device”) is a digital recordin...

    BIO-COMP SWVLK C, CLD 4.75X19.1MM

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code MAI·December 16, 2024

    COR24000136-000

    FDA Adverse Event
    No answer provided ·Product code REK·July 9, 2024

    DirectFRAP (Direct Flourescence Recovery After Photobleaching) Imaging System is an extension unit for Axio Observer that is used for microscopic analyses of dynamic processes within living cells. The DirectFRAP module is a component used in conjunction with Laser Scanning Microscopes, Non-Medical Devices for Research Use. The DirectFRAP Imaging System is a Class 3B laser system. The DirectFRAP Imaging System is a laser manipulation slider which allows coupling of laser light simultaneously with the conventional fluorescence illumination into the reflected-light beam path of the microscope system. Depending on the application, the laser light is used for the targeted bleaching of fluorophores for FRAP experiments or for the conversion of fluorophores within the cell.

    FDA Recall
    Terminated ·Zeiss, Carl Inc·Product code REK·April 28, 2011

    EQ-400-RH-QZ and EQ-400-LH-BK products Product Usage: The device is a very broadband light source emitting incoherent non-laser light from the Deep UV through the visible wavelengths.

    FDA Recall
    Open, Classified ·Energetiq Technology Inc·Product code REK·September 27, 2019

    LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging

    FDA Recall
    Terminated ·Product code REK·January 31, 2020

    The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging.

    FDA Recall
    Open, Classified ·Ithera Medical Gmbh Zielstattstr. 13 Munich Germany·Product code REK·January 8, 2025

    Carl Zeiss Microimaging Laser-TIRF (Total Internal Reflection Fluorescence) Imaging System is a component used in conjunction with Laser Scanning Microscopes, Non-Medical Devices for Research Use. The Laser-TIRF Imaging-System is a Class 3B laser system. The Laser TIRF Imaging System allows the visualization of substances or molecules being capable of fluorescing (excitable by light) by means of an electromagnetic (evanescent) field produced by total internal reflection.

    FDA Recall
    Terminated ·Zeiss, Carl Inc·Product code REK·April 28, 2011

    Research Laser

    FDA classification
    FDA Not Classified ·Research Laser

    Dek Optica Sp. j. Daniluk, Doleczek

    Manufacturer
    🇵🇱 Poland

    R.K. Manufacturing

    FDA registration
    R.K. Manufacturing·23 products·🇺🇸 United States

    ITL Dental

    FDA UDI
    EMERY ENTERPRISES INC·00817686024417·BEK Bone Expander Kit

    CARCINO-CEK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    REAK VIETNAM COMPANY LIMITED

    FDA registration
    REAK VIETNAM COMPANY LIMITED·11 products·🇻🇳 Vietnam