9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
CRANIOTOME BLADE OR NEURO BLADE
FDA 510(k)
FDA Class 2
·Neurology
Archon
FDA UDI
Nuvasive, Inc.·00887517310842·Archon Screw, 4.0x18mm S.T. Variable
Ceramco®
FDA UDI
Dentsply International Inc.·D00118814180·
SPINAL ELEMENTS BUTTRESS PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ScopeFlow Pure(TM)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LENSX LASER SYS
FDA Adverse Event
Malfunction
·ALCON LENSX LASER INC.·Product code OOE·April 9, 2014
LOCKING SCREW
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·December 20, 2012
ISERT ASPHERIC INTRAOCULAR LENS
FDA Adverse Event
Malfunction
·HOYA SURGICAL OPTICS INC.·Product code HQL·October 7, 2010
Pipeline Flex Embolization Device
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021