8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EasyTouch Safety Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST
FDA 510(k)
FDA Class 2
·Anesthesiology
PROMOS MODULAR SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PORT-A-CATH IMPLANTABLE ACCESS SYSTEM
FDA Adverse Event
Injury
·ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code LIT·November 12, 2025
TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·October 10, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 11, 2013
SIGNATURE INSTRUMENTATION SPRING DRILL PIN
FDA Adverse Event
Injury
·BIOMET·Product code LXH·June 30, 2011
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026