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

Compass BDS Biliary Stent

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BDS-3 BEAM DATA SCANNER

FDA 510(k)

FDA Class 1 ·Radiology

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

GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SNOREFREE

FDA 510(k)

FDA Class 2 ·Dental

MED-CARE EMERGENCY SHEARS

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

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

PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02

FDA 510(k)

FDA Class 1 ·Dental