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

C. Difficile Toxin Gene Amplification Assay

FDA classification

FDA Class 2 ·C. Difficile Toxin Gene Amplification Assay

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

Internal Hinged Elbow Fixator

FDA classification

FDA Class 2 ·Internal Hinged Elbow Fixator

Wearable Fall Injury Prevention Device

FDA classification

FDA Class 2 ·Wearable Fall Injury Prevention Device

SILKPRO laser hair removal system

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Over-The-Counter Powered Light Based Laser For Acne

FDA classification

FDA Class 2 ·Over-The-Counter Powered Light Based Laser For Acne

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM