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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VINTAGE LD 15G ADD-ON B
FDA UDI
SHOFU DENTAL CORPORATION·E235L86600·VINTAGE LD 15G ADD-ON B
Ohio
FDA UDI
OHIO MEDICAL, LLC·00628101616588·IFM 0-3 LPM TUBE USA OXY OH TYPE B
Ohio
FDA UDI
OHIO MEDICAL, LLC·00628101616274·IFM 0-15LPM TUBE USA AIR OH TYPE B
Ohio
FDA UDI
OHIO MEDICAL, LLC·00628101616038·IFM 0-15LPM TUBE USA OXY OH TYPE B
Ohio
FDA UDI
OHIO MEDICAL, LLC·00628101608255·IFM 0-3 LPM TUBE USA OXY OH TYPE B
Ohio
FDA UDI
OHIO MEDICAL, LLC·00628101616526·UNPCKD IFM 8 LPM T US OXY OF*N TYP B
Ohio
FDA UDI
OHIO MEDICAL, LLC·00628101608552·IFM 0-15LPM TUBE USA AIR OH TYPE B
Ohio
FDA UDI
OHIO MEDICAL, LLC·00628101608316·UNPCKD IFM 8 LPM T US OXY OF*N TYP B
Ohio
FDA UDI
OHIO MEDICAL, LLC·00628101616410·IFM 0-15LPM TUBE ISO OXY OH TYPE B
Ohio
FDA UDI
OHIO MEDICAL, LLC·00628101608798·IFM 0-15LPM TUBE USA OXY OH TYPE B
SIDE RAIL ON BED
FDA Adverse Event
Injury
·HILL-ROM CO.·Product code FNJ·March 26, 1996
nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.
FDA Enforcement
Class II
·Terminated·NordicNeuroLab AS·June 6, 2018
Coulter Clone B6-FITC Reagent
FDA Recall
Terminated
·Beckman Coulter Inc·April 28, 2003
nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.
FDA Recall
Terminated
·NordicNeuroLab AS Mollendalsveien 65c Bergen Norway·Product code LLZ·December 21, 2012
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
Posey Connected Twice-As Tough Cuffs, Wrists (for use on bed) (2794). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.
FDA Recall
Terminated
·J T Posey Company·Product code FMQ·April 20, 2009
Posey Connected Twice-As Tough Cuffs, Ankles (for use on bed) (2795). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.
FDA Recall
Terminated
·J T Posey Company·Product code FMQ·April 20, 2009
Special Order, Posey Connected Twice-As Tough Cuffs, Wrists (for use on bed) (S27947). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.
FDA Recall
Terminated
·J T Posey Company·Product code FMQ·April 20, 2009
Invacare IVC Home Care Bed (Foot Section with new head actuator from Linak.
FDA Recall
Terminated
·Invacare Corporation One Invacare Way·Product code LLI·June 9, 2003
Stryker InTouch 1.0 Zoom Critical Care Bed (Model 2140) with the Integrated PositionPro mattress (Model 2920) option. The device is intended to be used as an Intensive Care Unit bed.
FDA Recall
Terminated
·Stryker Medical Div. of Stryker Corporation·Product code FNL·January 5, 2009