7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
RIB RESECTOR
FDA 510(k)
FDA Class 1
·Neurology
AESKULISA ASCA A
FDA 510(k)
FDA Class 2
·Immunology
Kudu
FDA 510(k)
FDA Class 1
·Physical Medicine
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code DXY·February 9, 2013
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·January 6, 2011
FLOWGATE 8F X 85 CM
FDA Adverse Event
Malfunction
·CONCENTRIC MEDICAL·Product code DQY·July 22, 2014
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024