30 results · 22ms · Sources: EU EUDAMED, US FDA

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NON-CONTACT INFRARED THERMOMETER

FDA 510(k)
FDA Class 2 ·General Hospital

EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

FUJINON ULTRASONIC PROCESSOR

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

BIM400 IMPLANT MAGNET

FDA Adverse Event
Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·December 19, 2017

COCHLEAR BAHA ATTACT SYSTEM

FDA Adverse Event
Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·June 26, 2016

PROPHECY INFINITY

FDA Adverse Event
Malfunction ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HSN·March 29, 2021

ATTRACT SYSTEM

FDA Adverse Event
Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·October 15, 2015

COCHLEAR BAHA ATTACT SYSTEM

FDA Adverse Event
Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·August 17, 2016

BIM400 IMPLANT MAGNET

FDA Adverse Event
Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·August 17, 2016

SP MAGNET 3

FDA Adverse Event
Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·September 13, 2016

COCHLEAR BAHA ATTRACT SYSTEM

FDA Adverse Event
Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·August 14, 2016

BIM400 IMPLANT MAGNET

FDA Adverse Event
Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·October 8, 2025

OPTIFLUX 160NRE EIALYZER FINISHED ASSY.

FDA Adverse Event
Malfunction ·OGDEN MANUFACTURING·Product code FJI·May 23, 2013

ATTAIN OTW

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

TERUMO PERFUSION SYSTEM 8000

FDA Adverse Event
Injury ·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DTQ·August 12, 2008

COCHLEAR BAHA ATTACT SYSTEM

FDA Adverse Event
Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·August 10, 2016

PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES

FDA Adverse Event
Injury ·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·October 8, 2024

PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES

FDA Adverse Event
Malfunction ·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·October 19, 2023

PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES

FDA Adverse Event
Malfunction ·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·May 28, 2024

ELECSYS TSH ASSAY

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JLW·November 9, 2020