9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
AuST Steerable Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
A.R.T.™FEMORAL NAIL
FDA UDI
Biomet Orthopedics, LLC·00887868005404·
Cameron-Miller
FDA UDI
CAMERON-MILLER INC·B3702609420·
Sonablate
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·November 15, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 23, 2011
SURGICAL MESH
FDA Adverse Event
Injury
·CALDERA MEDICAL, INC.·Product code FTL·July 23, 2013
Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013