91 results
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71ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MONITORED THERAPEUTICS, INC.
FDA registration
MONITORED THERAPEUTICS, INC.·8 products·🇺🇸 United States
Turbine Assembly, Bagged for GoSpiro Spirometer
FDA UDI
Monitored Therapeutics, Inc.·00860000692823·Turbine Assembly, Bagged for GoSpiro Spirometer
GoSpiro
FDA UDI
Monitored Therapeutics, Inc.·00860000692809·Device Description:
The GoSpiro® is intended to...
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
USA-002 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. Brochure: "EXER-REST***A patented, FDA registered, Acceleration Therapeutics device delivering Whole Body Periodic Acceleration to the user for symptomatic relief of a wide range of complaints***Whole Body Periodic Acceleration (WBPA)***WBPA is accomplished utilizing the Ever-Rest device to move the body repetitively head to foot at approximately 140 times a minute. This repetitive motion adds pulses to your natural vascular pulse with each acceleration and deceleration of the body. These additional pulses act on the inner lining of blood vessels (endothelium) throughout the body, a process called pulsatile shear stress, to promote the release of beneficial substances (mediators). These mediators, such as nitric oxide, provide a wide range of health benefits that originate from the user's own body.***Nitric Oxide (NO) is released from endothelial cells that line the arterial walls. NO signals vascular smooth muscle to relax, thereby increasing blood flow throughout the circulation.***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.***USA-002 Rev A***" Printed marketing brochure
FDA Enforcement
Class II
·Terminated·Non-Invasive Monitoring Systems, Inc.·June 27, 2012
VITROS 4600 CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·March 8, 2022
HD CAMERA HEAD
FDA Adverse Event
Malfunction
·SHIRAKAWA OLYMPUS CO., LTD.·Product code FET·March 13, 2024
IMPELLA
FDA Adverse Event
Injury
·ABIOMED, INC. - 1220648·Product code PYX·March 5, 2026
VITROS 5600 INTEGRATED SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JJE·October 11, 2023
VITROS 5600 INTEGRATED SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·December 4, 2018
VITROS 5600 INTEGRATED SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·June 11, 2019
VITROS XT 7600 INTEGRATED SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·July 13, 2022
SYNCHRON LX® I 725 CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·May 4, 2011
UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEM (FULL SYSTEM)
FDA Adverse Event
BECKMAN COULTER INC.·Product code JJE·February 17, 2011
UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEM (FULL SYSTEM)
FDA Adverse Event
BECKMAN COULTER INC.·Product code JJE·March 3, 2011
UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEM (FULL SYSTEM)
FDA Adverse Event
BECKMAN COULTER INC.·Product code JJE·March 3, 2011
UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEM (FULL SYSTEM)
FDA Adverse Event
BECKMAN COULTER INC.·Product code JJE·March 3, 2011
UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEM (FULL SYSTEM)
FDA Adverse Event
BECKMAN COULTER INC.·Product code JJE·February 17, 2011
VITROS CHEMISTRY PRODUCTS VANC REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code LEH·July 11, 2024
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 9
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JIT·September 11, 2024