7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
NEUROMED OCTRODE MODEL MNR-88B/88C NEUROSTIM SYST
FDA 510(k)
FDA Class 2
·Neurology
ACUDATA INDICATENS MODEL 5A
FDA 510(k)
FDA Class 2
·Neurology
NOVA LITE(TM) ANA KSL
FDA 510(k)
FDA Class 2
·Immunology
FLOGARD
FDA Adverse Event
Malfunction
·SHARP CORPORATION OSAKA JAPAN·Product code FRN·January 9, 2013
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·November 11, 2010
INGEVITY
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·July 1, 2014
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