7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FOLEY CATHETER TEMPERATURE SENSOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CliniCloud Stethoscope
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDICAL DISPLAY, MD205MG
FDA 510(k)
FDA Class 2
·Radiology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 14, 2014
FORCETRIAD ELECTROSURGICAL GENERATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE GROUP LP·Product code GEI·December 4, 2012
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·October 14, 2010
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021