Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ARMSTRONG STERILE SALINE SOLUTION

Freedom Spinal Cord Stimulator System

FDA 510(k)

FDA Class 2 ·Neurology

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE TEST KIT

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE TEST KIT

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE TEST KIT

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE TEST KIT

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·THE DISINTEGRATOR PLUS LANCE/INSULIN NEEDLE DESTRUCTON DEVICE

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·THE DISINTEGRATOR INSULIN NEEDLE DESTRUCTION DEVICE

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·DISINTEGRATOR PRO NEEDLE DESTRUCTION DEVICE

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SODIUM CHLORIDE TABLETS, USP

BT-1000

FDA 510(k)

FDA Class 2 ·Neurology

Hi bebe super (Models BT-150S and BT-150L)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Infant Phototherapy Equipment

FDA 510(k)

FDA Class 2 ·General Hospital

Hi bebe plus

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA

FDA 510(k)

FDA Class 2 ·Immunology

Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test

FDA classification

FDA Class 2 ·Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test

DRM 2300 PLETHYSMOGRAPHIC CARDIOTACHOMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PULMOCATH INTRABRONCHIAL CATHETER

FDA 510(k)

FDA Class 2 ·Radiology

WATER FILLED GUM SOOTHER

FDA 510(k)

FDA Class 2 ·Dental

Procedure Mask with Ear Loops and Surgical Mask with Ties

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery