15 results · 51ms · 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