7 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EMG RECORDING RING ELECTRODE
FDA 510(k)
FDA Class 2
·Neurology
MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
FDA 510(k)
FDA Class 2
·Cardiovascular
Spine Innovation Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
ACCU-CHEK ® SMARTVIEW TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE, INC.·Product code LFR·July 30, 2015
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·February 9, 2013
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 23, 2014
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025