12 results
·
43ms
·
Sources: EU EUDAMED, US FDA
TYTAN GROMMET VENT TUBE, .040
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE
FDA 510(k)
FDA Class 2
·Orthopedic
CELSIUS CONTROL SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
PROXIMA HI OFFSET L SZ 4
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code KWZ·May 20, 2014
PLASMABLADE TISSUE DISSECTION DEVICE
FDA Adverse Event
Malfunction
·MEDTRONIC ADVANCED ENERGY LLC·Product code GEI·October 25, 2012
HARMONIC SCALPEL SHARP HOOK
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code LFL·August 16, 2007
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·September 24, 2019
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·March 27, 2017
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·March 5, 2019
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·March 17, 2021
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·November 12, 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