12 results
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26ms
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Sources: EU EUDAMED, US FDA
ENDAB DIGOXIN KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017712·K-Wire, Double Ended, Trocar Point, Diameter Si...
Bioplate®
FDA UDI
Bioplate, Inc.·M3848120540·Flexible Burr Hole Cover - Ø1.5 mm - 6 hole - 1...
Bioplate®
FDA UDI
Bioplate, Inc.·M384812054CP1·Flexible Burr Hole Cover - Ø1.5 mm - 6 hole - 1...
Bioplate®
FDA UDI
Bioplate, Inc.·M384812054US0·Flexible Burr Hole Cover - Ø1.5 mm - 6 hole - 1...
EZout
FDA UDI
STRYKER CORPORATION·07613327294507·Blade Pack, 54mm
INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V
FDA 510(k)
FDA Class 2
·Radiology
FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312
FDA 510(k)
FDA Class 2
·Cardiovascular
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 15, 2014
N/A
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NVZ·October 31, 2012
C-ARM
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·August 17, 2010
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