40 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040010297·Zirlux 16+ C3 100X16
Herculink Elite
FDA UDI
ABBOTT VASCULAR INC.·08717648078378·RX Herculink Elite Renal and Biliary Stent Syst...
Herculink Elite
FDA UDI
ABBOTT VASCULAR INC.·08717648078385·RX Herculink Elite Renal and Biliary Stent Syst...
QUICK-SET
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 20, 2025
SOFIA VERGARA
FDA UDI
FGX INTERNATIONAL INC.·00193033288917·
SOFIA VERGARA
FDA UDI
FGX INTERNATIONAL INC.·00193033288887·
SOFIA VERGARA
FDA UDI
FGX INTERNATIONAL INC.·00193033288863·
SOFIA VERGARA
FDA UDI
FGX INTERNATIONAL INC.·00193033288948·
SOFIA VERGARA
FDA UDI
FGX INTERNATIONAL INC.·00193033288900·
SOFIA VERGARA
FDA UDI
FGX INTERNATIONAL INC.·00193033288856·
SOFIA VERGARA
FDA UDI
FGX INTERNATIONAL INC.·00193033288931·
SOFIA VERGARA
FDA UDI
FGX INTERNATIONAL INC.·00193033288924·
SOFIA VERGARA
FDA UDI
FGX INTERNATIONAL INC.·00193033288955·
SOFIA VERGARA
FDA UDI
FGX INTERNATIONAL INC.·00193033288870·
SOFIA VERGARA
FDA UDI
FGX INTERNATIONAL INC.·00193033288894·
PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY
FDA 510(k)
FDA Class 2
·Cardiovascular
QUICK SET
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 10, 2025
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MQP·July 3, 2018