8 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OASYS System
FDA 510(k)
FDA Class 2
·Orthopedic
HNM Women Care
FDA UDI
HNM STAINLESS, LLC.·00812171029175·PESSARY, RING #5, W/O SUPPORT, 3"
PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE
FDA 510(k)
FDA Class 1
·Dental
SIZE 1 TRIATHLON POSTERIOR STABILIZED (PS) TIBIAL INSERT
FDA 510(k)
FDA Class 2
·Orthopedic
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·June 6, 2013
CVC KIT: 3-LUMEN 7 FR X 24 (60 CM)
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code FOZ·June 22, 2011
IMPLANTIUM
FDA Adverse Event
Injury
·DENTIUM·Product code DZE·September 3, 2008
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020