7 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RELIANCE METAL PRIMER
FDA 510(k)
FDA Class 2
·Dental
VIDAS RUB IGG
FDA 510(k)
FDA Class 2
·Microbiology
Endiscope, Endiscope Cervical
FDA 510(k)
FDA Class 2
·Orthopedic
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 29, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 25, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 20, 2012
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