Standard Polysomnograph With Electroencephalograph

FDA classification

FDA Class 2 ·Standard Polysomnograph With Electroencephalograph

Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter

FDA classification

FDA Class 2 ·Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter

Breast Milk Macronutrients Test System

FDA classification

FDA Class 2 ·Breast Milk Macronutrients Test System

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA classification

FDA Class 3 ·Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

Adjunctive Hemodynamic Indicator With Decision Point

FDA classification

FDA Class 2 ·Adjunctive Hemodynamic Indicator With Decision Point

Generator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-Led

FDA classification

FDA Not Classified ·Generator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-Led

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

FDA classification

FDA Class 2 ·Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

Extractor, Vein

FDA classification

FDA Class 1 ·Extractor, Vein

X-Ray Controls ? Combination

FDA classification

FDA Not Classified ·X-Ray Controls ? Combination

Hemostatic Device For Endoscopic Gastrointestinal Use

FDA classification

FDA Class 2 ·Hemostatic Device For Endoscopic Gastrointestinal Use

Over-The-Counter Powered Light Based Laser For Acne

FDA classification

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

Adjunctive Cardiovascular Status Indicator

FDA classification

FDA Class 2 ·Adjunctive Cardiovascular Status Indicator

Powder-Free Polychloroprene Patient Examination Glove

FDA classification

FDA Class 1 ·Powder-Free Polychloroprene Patient Examination Glove

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

Single Lumen Ecmo Cannula

FDA classification

FDA Class 2 ·Single Lumen Ecmo Cannula

Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System

FDA classification

FDA Class 2 ·Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System

Phase-Changing Fiducial Marker For Radiation Therapy

FDA classification

FDA Class 2 ·Phase-Changing Fiducial Marker For Radiation Therapy

Voltage Gated Calcium Channel (Vgcc) Antibody Assay

FDA classification

FDA Class 2 ·Voltage Gated Calcium Channel (Vgcc) Antibody Assay

Procalcitonin Assay

FDA classification

FDA Class 2 ·Procalcitonin Assay

Alfapump System

FDA classification

FDA Class 3 ·Alfapump System