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    REINA IMAGING

    FDA registration
    REINA IMAGING·5 products·🇺🇸 United States

    Stitching Platform with Handles/ Clear Stitching Stand

    FDA UDI
    Reina Imaging·00860001700169·Designed as a patient stabilizer for use when t...

    Weight Bearing DRP Holders

    FDA UDI
    Reina Imaging·00860001700176·Protect Grid and Image Receptor from Weight Bea...

    Protect-A-Grid

    FDA UDI
    Reina Imaging·00860001700183·The "Protect-A-Grid" line of Premium Grid Encas...

    Collim-Aid

    FDA UDI
    Reina Imaging·00860001700107·The Collim-Aid fits onto the collimator, shield...

    Trans-Former

    FDA UDI
    Reina Imaging·00860001700121·Device is a holder for digital detectors(DR Pan...

    MITEK FMS DUO PUMP +

    FDA Adverse Event
    Injury ·DEPUY MITEK·Product code HRX·January 21, 2014

    2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HTW·June 11, 2020

    1.8MM DRILL BIT/QC/100MM

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code DZI·June 11, 2020

    2.5MM DRILL BIT/QC/GOLD/110MM

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWE·July 2, 2020

    AEYE-DS RETINA SCREENING

    FDA Adverse Event
    Injury ·AEYE HEALTH INC.·Product code PIB·January 22, 2025

    PLASTIC SURGERY PACK - LABEL SAMPLE CONTENTS: (2) GOWN LGE SMS NON REINF T/WRAP L/F (1) MAYO STAND COVER REINF. LIF (10) GAUZE SPONGE 4" X 4" 16 PLY LIF (1) TABLE COVER 44" X 90" (1) DRAPE SHEET 70" X 100" LIF (2) SURGICAL BLADE #15 S/STEEL (1) DRAPE HEAD WIT APE 44" X 26" LIF (30) COTION TIP APPLIC 6" WOOD LIF (1) PVP PAINT 8" STICK SPONGE (1) NEEDLE & BLADE COUNTER 20C FOAM I MAG L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    PLASTIC SURGERY PACK - LABEL SAMPLE CONTENTS: (2) GOWN LGE SMS NON REINF T/WRAP L/F (1) MAYO STAND COVER REINF. LIF (10) GAUZE SPONGE 4" X 4" 16 PLY LIF (1) TABLE COVER 44" X 90" (1) DRAPE SHEET 70" X 100" LIF (2) SURGICAL BLADE #15 S/STEEL (1) DRAPE HEAD WIT APE 44" X 26" LIF (30) COTION TIP APPLIC 6" WOOD LIF (1) PVP PAINT 8" STICK SPONGE (1) NEEDLE & BLADE COUNTER 20C FOAM I MAG L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code LRO·May 20, 2014