15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GE 8CH FOOT ANKLE COIL
FDA 510(k)
FDA Class 2
·Radiology
ArgenZ HT+ 95x12 OM3
FDA UDI
ARGEN CORPORATION, THE·D818122694·Dental porcelain/ceramic restoration kit
2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
2.4MM VA LOCKING SCREW STARDRIVE 22MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·June 25, 2013
VA LOCKSCR Ø2.4 SELF-TAP L18 TAN
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HRS·July 15, 2013
ILAB ULTRASOUND IMAGING SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (CE)·Product code OBJ·May 21, 2013
PROFEMUR(R) COCR NECK
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code KWA·September 26, 2014
PINN MULTIHOLE W/GRIPTON 64MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·June 3, 2011
2.4MM TI LOCKING SCR SLF-TPN WITH STARDRIVE RECESS 18MM
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code HWC·June 21, 2017
SCREW, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HWC·December 24, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·July 30, 2015
2.4MM TI LOCKING SCR SLF-TPN WITH STARDRIVE RECESS 18MM
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code HWC·June 21, 2017
PLATE, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HRS·October 24, 2015
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018