CIRRUS OPEN

FDA 510(k)

FDA Class 2 ·Radiology

VELSCOPE VX

FDA 510(k)

FDA Class 2 ·Dental

IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10

FDA 510(k)

FDA Class 2 ·Hematology

IROOT BP, MODEL IRBP 4609

FDA 510(k)

FDA Class 2 ·Dental

IROOT BP PLUS

FDA 510(k)

FDA Class 2 ·Dental

ATA HCM MONOPLACE HYPERBARIC SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

DIGITEK TITANIUM ABUTMENT

FDA 510(k)

FDA Class 2 ·Dental

NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS

FDA 510(k)

FDA Class 2 ·Neurology

PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Test, Residual, Wbc In Leukoreduced Blood

FDA classification

FDA Class 2 ·Test, Residual, Wbc In Leukoreduced Blood

Bottle, Collection And Trap, Breathing System (Uncalibrated)

FDA classification

FDA Class 2 ·Bottle, Collection And Trap, Breathing System (Uncalibrated)

Test, Screening, For D Positive Fetal Rbc'S

FDA classification

FDA Class 2 ·Test, Screening, For D Positive Fetal Rbc'S

Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

FDA classification

FDA Class 2 ·Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

SILKPRO laser hair removal system

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Tenaculum, Uterine, Exempt

FDA classification

FDA Class 2 ·Tenaculum, Uterine, Exempt