ADMIRA SEAL

FDA 510(k)

FDA Class 2 ·Dental

FISSURE SEALER

FDA 510(k)

FDA Class 2 ·Dental

DELTON* PIT AND FISSURE SEALENT

FDA 510(k)

FDA Class 2 ·Dental

DEGUFILL (TM) WHIT-SEALANT

FDA 510(k)

FDA Class 2 ·Dental

TEETHMATE F-1

FDA 510(k)

FDA Class 2 ·Dental

ULTRASEAL ID

FDA 510(k)

FDA Class 2 ·Dental

ORALIN TLC LIGHT CURED PIT AND FISSURE SEALANT

FDA 510(k)

FDA Class 2 ·Dental

ALPHA-DENT PIT AND FISSURE SEALANT

FDA 510(k)

FDA Class 2 ·Dental

MAMMAPRINT

FDA 510(k)

FDA Class 2 ·Immunology

LungQ v3.0.0

FDA 510(k)

FDA Class 2 ·Radiology

LungQ Software

FDA 510(k)

FDA Class 2 ·Radiology

MAMMAPRINT

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO MAMMAPRINT

FDA 510(k)

FDA Class 2 ·Immunology

Transpara (2.1.0)

FDA 510(k)

FDA Class 2 ·Radiology

Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CO2 Laser Machine (Lume)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Sealant, Pit And Fissure, And Conditioner

FDA classification

FDA Class 2 ·Sealant, Pit And Fissure, And Conditioner

Myeloperoxidase, Immunoassay, System, Test

FDA classification

FDA Class 2 ·Myeloperoxidase, Immunoassay, System, Test

Test, Albumin Cobalt Binding

FDA classification

FDA Class 2 ·Test, Albumin Cobalt Binding