8 results
·
90ms
·
Sources: EU EUDAMED, US FDA
TRACH MATE
FDA 510(k)
FDA Class 1
·Anesthesiology
FLORET DRAIN/TRACHEOTOMY SPONGE
FDA 510(k)
FDA Unclassified
·Unknown
DENTOLOCK DENTURE ADHESIVE CREAM
FDA 510(k)
FDA Class 1
·Dental
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 28, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 15, 2012
FREESTYLE NAVIGATOR
FDA Adverse Event
Malfunction
·Product code LFR·September 14, 2010
ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·August 14, 2019
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