7 results
·
35ms
·
Sources: EU EUDAMED, US FDA
DUCKBILL VOICE PROSTHESIS & TRACHEO
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
PASCAL DYNAMIC CONTOUR TONOMETER
FDA 510(k)
FDA Class 2
·Ophthalmic
3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP
FDA 510(k)
FDA Class 2
·Anesthesiology
OPTIBOND XTR
FDA Adverse Event
Injury
·KERR CORPORATION·Product code KLE·May 27, 2014
CARDINAL
FDA Adverse Event
Malfunction
·PURITAN MEDICAL PRODUCTS COMPANY LLC·Product code KXG·October 31, 2012
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 13, 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