8 results
·
22ms
·
Sources: EU EUDAMED, US FDA
SPECIMEN SET
FDA 510(k)
FDA Class 1
·Pathology
ACUMED
FDA UDI
Acumed LLC·10806378099540·Ankle Plating System Case Base
ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VINYL EXAMINATION GLOVE, POWDER-FREE, YELLOW
FDA 510(k)
FDA Class 1
·General Hospital
INGENIO
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·May 9, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 5, 2007
AVF 15G X 1 BE 30CM W/CLAMP/WINGEATER
FDA Adverse Event
Injury
·JMS SINGAPORE PTE LTD·Product code FIE·October 24, 2012
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015