10,000 results
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221ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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VISUWELL(R) REAGIN TEST (MODIFICATION)
FDA 510(k)
FDA Class 2
·Microbiology
SYNERMED GLUCOSE REAGENT KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
FDA 510(k)
FDA Class 2
·Microbiology
X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
Myocardial Strain Software Application
FDA 510(k)
FDA Class 2
·Radiology
DESS Dental Smart Solutions
FDA 510(k)
FDA Class 2
·Dental
OTIS Optical Coherence Tomography System
FDA 510(k)
FDA Class 2
·Radiology
elysion-pro
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Easi-Vue® embolic microspheres System
FDA 510(k)
FDA Class 2
·Cardiovascular
ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.
FDA 510(k)
FDA Class 2
·Cardiovascular
BrightMatter Guide with BrightMatter Pointer
FDA 510(k)
FDA Class 2
·Neurology
MODIFICATION TO: VELSCOPE
FDA 510(k)
FDA Class 2
·Dental
EPLAB (ELECTROCARDIOGRAPHIC MONITOR)
FDA 510(k)
FDA Class 2
·Cardiovascular
VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
BIONAIRE HEPA AIR PURIFIERS /SH-1240, 1260, 1840, 1860, CH-3550
FDA 510(k)
FDA Class 2
·General Hospital
NemoScan
FDA 510(k)
FDA Class 2
·Radiology
QUANTIA IGE
FDA 510(k)
FDA Class 2
·Immunology
VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL
FDA 510(k)
FDA Class 2
·Radiology
FALLER STYLET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology