Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·IPAFLUOROFOCON A AND B

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·MICROSCAN(R) RAPID FLUOROGENIC PANELS

Dermal Cooling Pack/Vacuum/Massager

FDA classification

FDA Class 2 ·Dermal Cooling Pack/Vacuum/Massager

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 SYSTEM, MODELS VITEK 2 AND VITEK 2 XL

Wheelchair, Stair Climbing

FDA Pre-Market Approval

FDA Class 2 ·INDEPENDENCE IBOT 3000 MOBILITY SYSTEM

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT HAVAB/HAVAB EIA/IMX HAVAB

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT HAVAB-M/HAVAB-M EIA/IMX HAVAB-M

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MEDTRONIC FALCON CORONARY BALLOON DILATATION CATHETERS

Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

FDA classification

FDA Class 2 ·Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

N95 Respirator With Antimicrobial/Antiviral Agent

FDA classification

FDA Class 2 ·N95 Respirator With Antimicrobial/Antiviral Agent

Surgical Mask With Antimicrobial/Antiviral Agent

FDA classification

FDA Class 2 ·Surgical Mask With Antimicrobial/Antiviral Agent

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK COMPUTER AIDED DETECTTION SYSTEM FOR MAMMOGRAPHY

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·SUNLIGHT OMNISENSE 7000S ULTRASOUND BONE SONOMETER

N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies

FDA classification

FDA Class 2 ·N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·BAK/PROXIMITY(TM) INTERBODY FUSION SYSTEM

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)

Assay, Proliferation, In Vitro, T Lymphocyte

FDA classification

FDA Class 2 ·Assay, Proliferation, In Vitro, T Lymphocyte

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·CLARIS(TM) REWETTING DROPS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CUTTING BALLOON ULTRA

Sharps Needle Destruction Device

FDA Pre-Market Approval

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