Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·SHARPX NEEDLE DESTRUCTION UNIT

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·SHARPX

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·SHARP NEEDLE DESTRUCTION UNIT

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER M1000

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

Wheelchair, Stair Climbing

FDA Pre-Market Approval

FDA Class 2 ·INDEPENDENCE (TM) IBOT 3000/4000 MOBILITY SYSTEM

Wheelchair, Stair Climbing

FDA Pre-Market Approval

FDA Class 2 ·INDEPENDENCE IBOT 3000/4000 MOBILITY SYSTEM

Optical Coherence Tomography, Intravascular Catheter

FDA classification

FDA Class 2 ·Optical Coherence Tomography, Intravascular Catheter

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME CMV

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN

Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

FDA classification

FDA Class 2 ·Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

Electrode, Pacing And Cardioversion, Temporary, Epicardial

FDA classification

FDA Class 2 ·Electrode, Pacing And Cardioversion, Temporary, Epicardial

Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

FDA classification

FDA Class 2 ·Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

Insulin Autoantibody Kit

FDA classification

FDA Class 2 ·Insulin Autoantibody Kit

Burn Resuscitation Decision Support Software

FDA classification

FDA Class 2 ·Burn Resuscitation Decision Support Software

Organophosphate Test System

FDA classification

FDA Class 2 ·Organophosphate Test System

Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter

FDA classification

FDA Class 2 ·Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter

Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

FDA classification

FDA Class 2 ·Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Monitor, Extracellular Fluid, Lymphedema, Extremity

FDA classification

FDA Class 2 ·Monitor, Extracellular Fluid, Lymphedema, Extremity

Lynch Syndrome Test System

FDA classification

FDA Class 2 ·Lynch Syndrome Test System