8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACS DIGOXIN IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Couture Essence
FDA UDI
Carolon Company·00078301931231·
AQUASENS FLUID MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ADVANCE BIONICS LLC
FDA Adverse Event
Malfunction
·ADVANCED BIONICS·Product code MCM·June 25, 2014
MA204
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·January 28, 2013
REFLEXION SPIRAL X, 7F, VAR. RADIUS CIR. MAP. CATH
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, AF DIVISION·Product code DRF·November 11, 2010
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