10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dentrix Ascend Imaging
FDA 510(k)
FDA Class 2
·Radiology
ProLift Trial
FDA UDI
Life Spine, Inc.·00190837087760·
VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM)
FDA 510(k)
FDA Class 2
·Cardiovascular
T2 GREATER TROCHANTER NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
VERSYS FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER INC·Product code LPH·February 25, 2016
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE AG·Product code LZG·June 7, 2013
ISERT ASPHERIC INTRAOCULAR LENS
FDA Adverse Event
Malfunction
·HOYA SURGICAL OPTICS, INC.·Product code HQL·June 21, 2011
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·September 5, 2008
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 26, 2014
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016