132 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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FilmArray Pneumonia Panel plus
FDA 510(k)
FDA Class 2
·Pathology
BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)
FDA 510(k)
FDA Class 2
·Pathology
FilmArray Pneumonia Panel plus
FDA 510(k)
FDA Class 2
·Pathology
Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
FDA classification
FDA Class 2
·Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
Compass BDS Biliary Stent
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ORTHOPHOS 3/3 CEPH/3 DS
FDA 510(k)
FDA Class 2
·Dental
ORTHO ELT-8/DS HEMATOLOGY ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG
FDA 510(k)
FDA Class 2
·Hematology
SONATA 3-D IMAGING ACCESSORY, MODEL 3DS
FDA 510(k)
FDA Class 2
·Radiology
ZEIMER SELF TONOMETER
FDA 510(k)
FDA Class 2
·Ophthalmic
STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090
FDA 510(k)
FDA Class 2
·Hematology
GDS ENZYMATIC THEOPHYLLINE REAGENT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CONTROL AND LINEARITY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ACETASITE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SNOREFREE
FDA 510(k)
FDA Class 2
·Dental
FULL BREATH SLEEP APPLIANCE LOWER (FBSL)
FDA 510(k)
FDA Class 2
·Dental
FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR
FDA 510(k)
FDA Class 2
·Dental
GLUCOSITE TEST SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE)
FDA 510(k)
FDA Class 2
·Dental
HEMOSITE TEST SYSTEM
FDA 510(k)
FDA Class 2
·Hematology