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    DOME INC

    FDA registration
    DOME INC·3 products·🇺🇸 United States

    DOME Coronado Dental Delivery Unit

    FDA UDI
    Dome, Inc.·D1351480·Dental delivery system instrument unit, pneumatic

    DOME Innovation Chair

    FDA UDI
    Dome, Inc.·D1355370·Dental chair, electric

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC.·Product code LPB·February 21, 2019

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·January 9, 2020

    RADI

    FDA Adverse Event
    Injury ·RADI MEDICAL SYSTEMS, INC.·Product code MGB·November 20, 2003

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·March 7, 2019

    BARDEX® I.C. COMPLETE CARE® FOLEY CATHETER TRAY

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code MJC·August 21, 2019

    CONTINUUM TRILOGY ALLOFIT DOME IMPACTOR

    FDA Adverse Event
    Malfunction ·ZIMMER INC.·Product code HWA·October 12, 2010

    THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·February 14, 2020

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC.·Product code LPB·September 6, 2019

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·November 5, 2019

    CONTINUUM TRILOGY IT ALLOFIT IT ACETABULAR SYSTEMS DOME IMPACTOR

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code HWA·March 11, 2010

    THMCL SMTCH SF BID, TC, D-F

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC.·Product code LPB·August 18, 2020

    BALLARD CLOSED SUCTION CATHETER, DOUBLE SWIVEL ELBOW

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL INC.·Product code BSY·June 3, 2019

    BALLARD CLOSED SUCTION CATHETER, T-PIECE

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL INC.·Product code BSY·July 22, 2019

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·January 30, 2024

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·November 18, 2019

    VRV-11C VACUUM RELIEF VALVE

    FDA Adverse Event
    Injury ·QUEST MEDICAL, INC.·Product code DWD·June 7, 2013

    COVERGE ACETABULAR SYSTEM HEMISPHERICAL POROUS SHELL WITH SEALED SCREWHOLES

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code KWB·November 5, 2008