8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
POWERED TREADMILL (30/ST)
FDA 510(k)
FDA Class 1
·Physical Medicine
Ceramill
FDA UDI
Amann Girrbach AG·E4947610411·
US SPINE FACET FIXATION SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
OsteoMed ExtremiLOCK Wrist Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
STEALTH 360 ORBITAL ATHERECTOMY SYSTEM
FDA Adverse Event
Injury
·CARDIOVASCULAR SYSTEMS INCORPORATED·Product code MCW·April 21, 2014
ACCU-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 19, 2007
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 26, 2012
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024