2,701 results
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41ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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InPen System App (MMT-8060 (iOS), MMT-8061 (Android))
FDA 510(k)
FDA Class 2
·Anesthesiology
DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE)
FDA 510(k)
FDA Class 2
·Anesthesiology
Rooti Rx ECG Event Recorder, Rooti Link APP Software
FDA 510(k)
FDA Class 2
·Cardiovascular
VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator
FDA 510(k)
FDA Class 2
·General Hospital
TYPE III DENTAL GOLD ALLOY FOR CROWN & BRIDGE APP.
FDA 510(k)
FDA Class 2
·Dental
ELECTROSTIM I.F.
FDA 510(k)
FDA Class 2
·Neurology
ES 180-DCM MUSCLE STIMULATOR
FDA 510(k)
FDA Class 2
·Physical Medicine
ELECTROSTIM MST
FDA 510(k)
FDA Class 2
·Neurology
KINESTIM MUSCLE STIMULATOR
FDA 510(k)
FDA Class 2
·Physical Medicine
Helix Genetic Health Risk App for late-onset Alzheimers disease
FDA 510(k)
FDA Class 2
·Immunology
t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App
FDA 510(k)
FDA Class 2
·Microbiology
MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
FREEWAY LITE NEBULIZER COMPRESSOR
FDA 510(k)
FDA Class 2
·Anesthesiology
VENTSTREAM DRUG NEBULIZER
FDA 510(k)
FDA Class 2
·Anesthesiology