32 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Uni-FuZe-P Bone Putty
FDA 510(k)
FDA Class 2
·Orthopedic
HHM
FDA UDI
Oticon A/S·05707131354891·G500 SC, MINIRITE 312 2.4G C058 HHM
Disposable Blade
FDA UDI
KATENA PRODUCTS, INC.·00841668113196·BARD-PARKER BLADE #11 PACK OF 50
Symmetry Little
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482057766·Symmetry® Retractor, Little, 11 mm x 16 mm
EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CURRY MULTIMODAL NEUROIMAGING SOFTWARE
FDA 510(k)
FDA Class 2
·Neurology
GORE TAG THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES,INC·Product code MIH·October 15, 2008
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013
EVOLUT R TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·August 7, 2017
COREVALVE REVALVING SYSTEM
FDA Adverse Event
Death
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·August 7, 2017
SILVERHAWK BTK
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code MCW·April 11, 2017
FLEXCATH ADVANCE STEERABLE SHEATH
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code DRA·August 28, 2017
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code DXY·December 28, 2017
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code DXY·December 1, 2017
VALVE CONTEGRA
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code MWH·September 5, 2018
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·March 9, 2017
MELODY TRANSCATHETER PULMONARY VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISON·Product code NPV·September 5, 2018
FLEXCATH ADVANCE STEERABLE SHEATH
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code DRA·August 28, 2017
HEARTWARE® VENTRICULAR ASSIST SYSTEM - PUMP
FDA Adverse Event
Injury
·HEARTWARE·Product code DSQ·August 29, 2017