12 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
syngo.CT Applications
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
DEPUY MITEK, LLC·10886705007301·Cortical Screw 4.5mm x 50mm
TriVerse Tibial Alignment Ankle Clamp
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215108953·
VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SLEEP PROFILER
FDA 510(k)
FDA Class 2
·Neurology
QUADRA R FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·March 30, 2026
VAPR VUE GENERATOR
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code GEI·January 28, 2019
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MANUFACTURING·Product code LKK·November 4, 2008
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 23, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
MECTACER BIOLOX OPTION HEADS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 7, 2025
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018