8 results
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34ms
·
Sources: EU EUDAMED, US FDA
LYSOL I.C. BRAND QUATERNARY CLEANER DISINFECTANT
FDA 510(k)
FDA Class 1
·General Hospital
SENSILIGHT/ SENSILIGHT PLUS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HATRIC, 6&7MM, 9&10MM, 11&12MM, 14&15MM, MODELS AR-13000B-07, -10, -12, -15
FDA 510(k)
FDA Class 2
·Orthopedic
CLEARVIEW UTERINE MANIPULATOR
FDA Adverse Event
Injury
·CLINICAL INNOVATIONS, LLC·Product code LKF·June 11, 2024
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·April 17, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·February 2, 2013
COAGUCHEK® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·December 29, 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