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    AVAILS MEDICAL, INC.

    FDA registration
    AVAILS MEDICAL, INC.·2 products·🇺🇸 United States

    US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Ever-Rest US Brochure US-001 Rev A. Brochure: "***AT acceleration THERAPEUTICS***At Non-Invasive Medical Solutions (NIMS) we pride ourselves on being at the forefront of developing drug free wellness solutions coupled with accredited peer-reviewed clinical research...***Whole Body Periodic Acceleration (WBPA) therapy has been demonstrated to naturally activate the release of beneficial mediators like Nitric Oxide (NO) throughout the vasculature.***Nitric Oxide [NO] supports the functioning of endothelial cells that line the arterial walls. NO signals vascular smooth muscle to relax, thereby increasing blood flow through arteries and veins. With age arterial production and availability of Nitric oxide declines.***NiMS 4400 Biscayne Blvd., Miami, FL 33137 P 305.575.4200 F 305357534201***[email protected] www.nims-inc.com***NIMS, Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems, Inc.***US-001 Rev A***" Printed marketing brochure

    FDA Enforcement
    Class II ·Terminated·Non-Invasive Monitoring Systems, Inc.·June 27, 2012

    Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics, Inc. Foster City, CA IntelliSpace PACS are image management systems intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RE, RT, MG, SC, VL, as well as hospital/radiology information systems.

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Informatics, Inc.·November 20, 2013

    Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2104 Medium 8 x 15 Inch 1/EA, 24 ENCA ASL 2105 Large 8.5 x 17.5 Inch 1/EA, 24 ENCA ASL 2106 Extra-Large 9 x 20 Inch 1/EA, 24 ENCA ASL 2150 Universal 7 x 18 Inch 1/EA, 24 ENCA Medical - An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

    FDA Enforcement
    Class II ·Terminated·Owens & Minor Distribution, Inc.·December 28, 2016

    Flexible Implant tube, blind end, 350 mm, part # GM11003730, labeled in part ***Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304 USA www.varian.com***. Available as single unit or contained in the Flexible Interstitial Implant Tube Set, part number GM11004680. For use with the Varian GammaMed Plus brachytherapy afterloader device.

    FDA Recall
    Terminated ·Varian Medical Systems·Product code JAQ·April 14, 2005

    CORTRAK ENTERAL ACCESS SYSTEM

    FDA Adverse Event
    Injury ·AVANOS MEDICAL INC.·Product code KNT·May 25, 2023

    PERFUSOR SPACE

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·July 12, 2016

    VISTA BASIC - IFVB

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·October 14, 2016

    VISTA BASIC - IFVB

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·October 14, 2016

    INFUSOMAT SPACE ACM-KIT

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

    PERFUSOR SPACE

    FDA Adverse Event
    Malfunction ·B.BRAUN MELSUNGEN AG·Product code FRN·May 6, 2016

    INTROCAN SAFETY®

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code DQR·December 2, 2016

    VISTA BASIC - IFVB

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·October 28, 2016

    INTROCAN SAFETY®

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code DQR·December 2, 2016

    INTROCAN SAFETY®

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code DQR·December 2, 2016

    VISTA BASIC - IFVB

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·March 17, 2016

    VISTA BASIC - IFVB

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·July 29, 2016

    TECNIS CL

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HQL·November 6, 2012

    INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 16FR DILATOR

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL INC.·Product code KGC·November 25, 2020

    PMG-ADVANCED V4.2A

    FDA Adverse Event
    Injury ·AVANOS MEDICAL INC.·Product code GEI·April 3, 2024