8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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C-REACTIVE PROTEIN LATEX KIT
FDA 510(k)
FDA Class 2
·Immunology
IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST
FDA 510(k)
FDA Class 1
·Microbiology
SONY CINE VIDEO SYSTEM SME-3500
FDA 510(k)
FDA Class 2
·Radiology
CONSULTA CRT-D
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NIK·February 11, 2013
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·December 14, 2010
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
FDA Adverse Event
C.T.M. SHANGHAI·Product code INI·July 24, 2014
CAPTURE-R READY-SCREEN 3
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code QHT·April 4, 2023
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026