9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Leva Spacer System
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814251·GENUMEDI PT SILVER R II
Prime Medical LLC
FDA UDI
Prime Medical LLC·00850055249295·PrimePadPlus-K15-3422
ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE
FDA 510(k)
FDA Class 1
·Dental
STERRAD CYCLESURE BIOLOGICAL INDICATOR
FDA 510(k)
FDA Class 2
·General Hospital
VALIANT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·October 8, 2014
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 8, 2013
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 7, 2011
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023