13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Graft Delivery Device with Integrated Stylet
FDA 510(k)
FDA Class 2
·General Hospital
ProLift
FDA UDI
Life Spine, Inc.·00190837138028·
ProLift
FDA UDI
Life Spine, Inc.·00190837086268·
ELECSYS PRECICONTROL BONE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CHLORAPREP ONE STEP HI-LITE ORANGE
FDA Adverse Event
Malfunction
·CAREFUSION 213, LLC 0113·Product code KXG·August 23, 2021
CHLORAPREP ONE STEP HI-LITE ORANGE
FDA Adverse Event
Malfunction
·CAREFUSION 213, LLC 0113·Product code KXG·August 23, 2021
CHLORAPREP ONE STEP HI-LITE ORANGE
FDA Adverse Event
Malfunction
·CAREFUSION 213, LLC 0113·Product code KXG·August 23, 2021
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013
DUROM US ACETABULAR COMPONENT 52/46 L
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 28, 2011
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MANUFACTURING·Product code LKK·September 4, 2008
COREVALVE TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·September 30, 2022
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016