8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYSTEM 6500 ABC ELECTROSURGICAL UNIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LEVEL ONE
FDA UDI
KLS-Martin L.P.·00888118097149·PLIERS, STERNOTOMY, HEMI
MRP-7000(1) : 2-D INFLOW MR ANGIOGRAPHY
FDA 510(k)
FDA Class 2
·Radiology
TAS-211/2.3 ULTRATHIN FLEXIBLE ENDOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·June 25, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·February 11, 2013
ISOFLEX S
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 10, 2011