11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DeGen Medical E3 MIS Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814725·GENUMEDI EXTRA WIDE SAND SIZE IV
OPTICROSS? HD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·July 1, 2025
HUMELOCK II CEMENTED SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PEZO INTERBODY CAGES SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·June 17, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·July 24, 2011
ICEROD PLUS 1.5 CRYOABLATION SYSTEM
FDA Adverse Event
Malfunction
·GALIL MEDICAL LTD.·Product code GEH·August 11, 2014
ATTUNE RP TIB BASE SZ 4 CEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code NJL·July 29, 2019
Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018