146 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment
FDA classification
FDA Class 2
·Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment
Belun Ring BLR-200 (BLR-200)
FDA 510(k)
FDA Class 2
·Cardiovascular
Tyece OTC TENS Device
FDA 510(k)
FDA Class 2
·Neurology
BLOOD PRESSURE METER MODEL NO. BPM888
FDA 510(k)
FDA Class 2
·Cardiovascular
NEO DENTA ZIRCONIA
FDA 510(k)
FDA Class 2
·Dental
BRINDLEY & SMITH ET-1000
FDA 510(k)
FDA Class 2
·Neurology
HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK BRANDED BPM1 SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
FORTEC MI-150 DIGITAL BLOOD PRESSURE METER
FDA 510(k)
FDA Class 2
·Cardiovascular
FORTEC MI-100, MI-50 DIGITAL BLOOD PRESSURE METER
FDA 510(k)
FDA Class 2
·Cardiovascular
FDTENS 2010
FDA 510(k)
FDA Class 2
·Neurology
HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AND KINETIK BRANDED IET1 SERIES
FDA 510(k)
FDA Class 2
·General Hospital
PanopticAI Vital Signs
FDA 510(k)
FDA Class 2
·Cardiovascular
ANDORATE® Suction Valve and ANDORATE® Biopsy Valve
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
FORTEC MI-305 & 306 DIGITAL THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
SURGICAL FACE MASKS PLUS ANTI-FOG SHIELD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Tyece OTC EMS System
FDA 510(k)
FDA Class 2
·Physical Medicine
AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406
FDA 510(k)
FDA Class 2
·Neurology
SMOKE EVACUATION ATTACHEMENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HTS ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology