7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
N-CHANNEL
FDA 510(k)ENDOSCANN
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ELISA PLUS SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 27, 2014
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·November 15, 2012
PROTECTA XT CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2015
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018