8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
12-9170 SERIES II TOTAL HIP
FDA 510(k)
FDA Class 2
·Orthopedic
SMITH & NEPHEW MODULAR FEMORAL HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
GLOVES, STERILE LATEX SURGEON'S
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ACUITY
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code OJX·April 21, 2014
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 23, 2007
NEUROFORM EZ® 3
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code NJE·September 26, 2012
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
FDA Enforcement
Class II
·Terminated·Abbott Vascular·October 3, 2012
ACCOLADE DR EL MRI (Model L331)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025