8 results
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20ms
·
Sources: EU EUDAMED, US FDA
MODEL 3000C CALORIC IRRIGATOR
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Mini Twin
FDA UDI
Rmo, Inc.·00885797692214·STD EDG MINILP 022 HK/345 5-5 20EA
PuraStat-RM
FDA 510(k)
FDA Unclassified
·Unknown
FREEDOM INGUINAL HERNIA IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INRATIO/INRATIO2 TEST STRIPS
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO INC.·Product code GJS·March 26, 2014
ATTAIN ABILITY PLUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·October 31, 2012
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 25, 2010
Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled & straight tip, 1/4" & 3/8" flare, Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·July 30, 2014