9 results
·
35ms
·
Sources: EU EUDAMED, US FDA
PEC IMPLANT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
POWERED MUSCLE STIMULATOR
FDA 510(k)
FDA Class 2
·Physical Medicine
U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
REUSABLE NEONATAL SINGLE HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 9, 2017
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·November 23, 2010
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 14, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 3, 2014
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·October 15, 2025
REUSABLE NEONATAL SINGLE HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 23, 2023