BEUDAMED
    10,000 results · 299ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    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

    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

    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

    CORTRAK ENTERAL ACCESS SYSTEM

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

    BALLARD CLOSED SUCTION SYSTEM, NEO/PEDS, 6 F, ELBOW

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL INC.·Product code BSY·June 23, 2023

    UNKNOWN NEO MED NASOGASTRIC TUBE

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL INC.·Product code FPD·March 19, 2024

    ENFIT PVC FEEDING TUBE ORANGE 8FR 40CM

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL INC.·Product code KNT·October 24, 2024

    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

    ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW*, 400 ML, 2-14 ML/HR

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL - IRVINE·Product code MEB·March 2, 2019

    BALLARD CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS, 6 F, Y-ADAPTER

    FDA Adverse Event
    Malfunction ·Product code BSY·December 8, 2020

    BALLARD TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, DOUBLE SWIVEL ELBOW

    FDA Adverse Event
    Malfunction ·Product code BSY·July 2, 2021

    AVANOS CURVED SHARP RF CANNULA, RADIOPAQUE MARKER

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL INC.·Product code GXI·January 12, 2021

    BALLARD CLOSED SUCTION SYSTEM FOR NEONATES / PEDIATRICS, 5 F, Y-ADAPTER

    FDA Adverse Event
    Injury ·Product code BSY·February 24, 2021

    INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22FR DILATOR

    FDA Adverse Event
    Injury ·AVANOS MEDICAL INC.·Product code KGC·December 28, 2018

    MIC-KEY* G-18 INTRODUCER KIT

    FDA Adverse Event
    Injury ·AVANOS MEDICAL INC.·Product code KGC·December 28, 2018

    ON-Q PUMP FIXED FLOW

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL - IRVINE·Product code MEB·March 30, 2020

    CORFLO STANDARD PEG KIT - PULL METHOD

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL INC.·Product code KNT·April 19, 2019

    BALLARD 1500 FLEX HEAT AND MOISTURE EXCHANGER

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL INC.·Product code BYD·September 27, 2019

    BALLARD 1500 FLEX HEAT AND MOISTURE EXCHANGER

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL INC.·Product code BYD·September 27, 2019