2,701 results · 41ms · Sources: EU EUDAMED, US FDA

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 Alzheimer’s 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