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    AIRS Medical Inc.

    FDA registration
    AIRS Medical Inc.·3 products·🇰🇷 South Korea

    SwiftMR

    FDA UDI
    AIRS Medical Inc.·08800124700136·SwiftMR is a stand-alone medical imaging softwa...

    SwiftMR

    FDA UDI
    AIRS Medical Inc.·08800124700099·SwiftMR is a stand-alone software solution inte...

    SwiftMR

    FDA UDI
    AIRS Medical Inc.·08800124700075·

    SwiftSight-Brain

    FDA UDI
    AIRS Medical Inc.·08800124700129·

    SwiftMR

    FDA UDI
    AIRS Medical Inc.·08800124700105·SwiftMR is a stand-alone software solution inte...

    SwiftMR

    FDA UDI
    AIRS Medical Inc.·08800124700006·

    LCI MEDICAL INC AIR/PAL

    FDA 510(k)
    FDA Class 2 ·General Hospital

    8713050U

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·August 1, 2016

    VISTA®

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·January 30, 2017

    INFUSOMAT

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·October 26, 2020

    INFUSOMAT®

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·June 25, 2021

    ACIST Medical Systems Inc. The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

    FDA Enforcement
    Class II ·Terminated·Acist Medical Systems·April 24, 2013

    INFUSOMAT®

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·May 17, 2018

    INFUSOMAT®

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·May 17, 2018

    INFUSOMAT®

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·May 17, 2018

    UNKNOWN, VAP CLOSED SUCTION CATHETERS & ACCESSORIES

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL INC.·Product code BSY·July 23, 2024

    INFUSOMAT SPACE

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·August 3, 2016

    INFUSOMAT

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·January 22, 2020

    SEAC Advanced Dental System, Model A591561 The SEAC Advanced Dental System is a self-contained dental delivery system with a built-in air compressor,vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced Dental System can also be upgraded to include a Micadent air abrasion system mounted inside the unit with the handpiece mounted in a holder along side the other handpiece connections. The Micadent is used to perform intra¿ oral air abrasion procedures including etching and preparing surfaces for composite restoration. The SEAC Advanced Dental System is substantially similar in design and functions as the SEAC Mobile Dental System manufactured by ASI Medical, Inc. The Micadent is manufactured by Medidents and will be supplied to ASIas a completed product. The Micadent is substantially the same as it is provided and is attached to an accessory air line inside the SEAC unit for operation. It is intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings and/or mobile applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law.

    FDA Enforcement
    Class II ·Terminated·ASI Medical, Inc.·December 25, 2013