8 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CAVERMAP SURGICAL AID
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
artegral life
FDA UDI
Merz Dental GmbH·D7091993436·anteriors; shade D2; mould BOL
MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT
FDA 510(k)
FDA Class 1
·Cardiovascular
VITA Ambria
FDA 510(k)
FDA Class 2
·Dental
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·March 7, 2013
ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·February 8, 2011
ADAPTA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·August 8, 2014
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020