16 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTRAMEDULLARY COMPRESSION ARTHRODESIS (ICA) NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
BD ChloraShield IV Dressing with CHG Antimicrobial
FDA 510(k)
FDA Unclassified
·Unknown
GREAT GLOVE POWDER FREE VINYL EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·May 20, 2014
ADAPTA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·February 9, 2013
ECHELON*FLEX60 ARTICULATING
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GDW·January 7, 2011
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DXC·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DXC·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 1, 2015