9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
BIRTHWELL BIRTHING SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ASPIRE RX-LP6 ASPIRATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MODEL J-5 MVO-MONITOR
FDA 510(k)
FDA Class 2
·Physical Medicine
QUATTRODE LEAD WIDE SPACED, 60 CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZF·August 30, 2016
QUATTRODE LEAD WIDE SPACED, 90 CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZF·August 30, 2016
OASYS 4.0 X 32MM PA SCREW MEDIAL
FDA Adverse Event
Malfunction
·STRYKER SPINE-FRANCE·Product code MNI·May 27, 2014
RESTORE ADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 14, 2012
KINETIX PTCA GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQX·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