8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
WISP MODEL 710
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CoRoent
FDA UDI
Nuvasive, Inc.·00887517822093·Interlock II Trial, 11x17x14mm 30° Stop
BioFlux Device
FDA 510(k)
FDA Class 2
·Cardiovascular
TILITE AERO X
FDA 510(k)
FDA Class 1
·Physical Medicine
DUROM ACETABULAR COMPONENT
FDA Adverse Event
Other
·ZIMMER GMBH·Product code KWA·March 19, 2014
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·October 2, 2012
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT AG (PRESSATH)·Product code LZS·July 23, 2010
Set-Up Pack, Kit number PSS1305(B and PSS1305(C convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016