9 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARGEDENT 51SF
FDA 510(k)
FDA Class 2
·Dental
VARIAX
FDA UDI
Stryker GmbH·07613327177169·Plate Insert
LPS METAPHYSEAL SLEEVE (LIMB PRESERVATION SYSTEM)
FDA 510(k)
FDA Class 2
·Orthopedic
FLEXI-LUME LED SYSTEM
FDA 510(k)
FDA Class 2
·Dental
CLEARVIEW UTERINE MANIPULATOR
FDA Adverse Event
Injury
·CLINICAL INNOVATIONS, LLC·Product code LKF·June 11, 2024
HEMOCHRON JR SIGNATURE PLUS SYSTEM
FDA Adverse Event
Injury
·INTERNATIONAL TECHNIDYNE CORP·Product code JPA·June 19, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·February 2, 2013
PIONEER MATTRESS 30"
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIVISION·Product code IKY·December 9, 2010
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020