15 results
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51ms
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Sources: EU EUDAMED, US FDA
KetoSens Multi Blood ?-Ketone Monitoring System
FDA registration
i-SENS Wonju Factory·1 product·🇰🇷 South Korea
KetoSens Multi Blood B-Ketone Monitoring System
FDA registration
I-SENS USA, INC.·1 product·🇺🇸 United States
KetoSens Multi Blood ?-Ketone Monitoring System
FDA registration
I-SENS Songdo Factory 2·1 product·🇰🇷 South Korea
KetoSens Multi Blood ?-Ketone Monitoring System
FDA registration
I-SENS, INC.·1 product·🇰🇷 South Korea
KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Nitroprusside, Ketones (Urinary, Non-Quant.)
FDA classification
FDA Class 1
·Nitroprusside, Ketones (Urinary, Non-Quant.)
PCECG-1200System with MEANS Interpretation (I3)
FDA registration
NORAV MEDICAL LTD.·1 product·🇮🇱 Israel
SLEEPNET CORPORATION
FDA registration
SLEEPNET CORPORATION·1 product·🇺🇸 United States
PCECG-1200System with MEANS Interpretation (I3)
FDA registration
Norav Medical GmbH·1 product·🇩🇪 Germany
PCECG-1200System with MEANS Interpretation (I3)
FDA registration
Norav Medical Inc.·1 product·🇺🇸 United States
REVERA WOUND CARE, MODEL MDW0060
FDA 510(k)
FDA Unclassified
·Unknown
PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS)
FDA 510(k)
FDA Class 2
·Cardiovascular
Digital Breast Tomosynthesis
FDA Pre-Market Approval
FDA Class 3
·ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
FDA classification
FDA Class 2
·Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Dressing, Wound, Drug
FDA classification
FDA Unclassified
·Dressing, Wound, Drug