7 results
·
24ms
·
Sources: EU EUDAMED, US FDA
TOBRAMYCIN CONTROL SERUM
FDA 510(k)
FDA Class 1
·Clinical Toxicology
UCLA CCM Abutment
FDA 510(k)
FDA Class 2
·Dental
ENDURAVENT-5 VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
PERCUFLEX? PLUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code FGE·May 6, 2014
REPLY
FDA Adverse Event
Injury
·SORIN CRM S.R.L.·Product code NVZ·October 12, 2012
V200 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·August 10, 2010
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