8 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Oticon
FDA UDI
Oticon A/S·05707131334787·OPN 3, KIT 312 2.4G NFM 90 L C001
ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LANX FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PURITAN BENNETT 980 SERIES VENTILATOR
FDA Adverse Event
Malfunction
·MEDTRONIC/COVIDIEN·Product code CBK·September 17, 2025
CELL-DYN RUBY ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·July 28, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·June 21, 2013
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·October 17, 2014