7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WAKO(TM) IGA-HA DIRECT
FDA 510(k)
FDA Class 2
·Immunology
BeautiBond Universal
FDA 510(k)
FDA Class 2
·Dental
VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551
FDA 510(k)
FDA Class 2
·Ophthalmic
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 29, 2014
ENDEAVOR SPRINT RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·December 20, 2012
VISISTAT SKIN STAPLER 35W
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code GDT·September 30, 2010
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025