11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FUJIFILM DOUBLE BALLOON ENDOSCOPES EN-450T5/W
FDA Adverse Event
Death
·FUJIFILM CORPORATION·Product code FDA·January 26, 2024
Vanguard Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304673977·
Vanguard Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304648050·
ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC
FDA 510(k)
FDA Class 2
·Cardiovascular
IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FREESTYLE AORTIC ROOT BIOPROSTHESIS
FDA Adverse Event
Death
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·December 9, 2018
EXTENSION SET WITH T-CONN. SL
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPA·October 3, 2013
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008
PROSTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code KNS·July 8, 2011
M2A 38MMX52MM CUP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 22, 2013