Infant Supine Sleep System

FDA classification

FDA Class 2 ·Infant Supine Sleep System

Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody

FDA classification

FDA Class 2 ·Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody

Calprotectin, Fecal

FDA classification

FDA Class 2 ·Calprotectin, Fecal

Adjunctive Heart Failure Status Indicator

FDA classification

FDA Class 2 ·Adjunctive Heart Failure Status Indicator

Adjunctive Cardiac Amyloidosis Status Indicator

FDA classification

FDA Class 2 ·Adjunctive Cardiac Amyloidosis Status Indicator

Injector, Pen

FDA classification

FDA Class 2 ·Injector, Pen

Biliary Stent System For Benign Strictures

FDA classification

FDA Class 2 ·Biliary Stent System For Benign Strictures

Adjunctive Hemodynamic Indicator With Decision Point For Military Use

FDA classification

FDA Class 2 ·Adjunctive Hemodynamic Indicator With Decision Point For Military Use

Intense Pulsed Light Device For Managing Dry Eye

FDA classification

FDA Class 2 ·Intense Pulsed Light Device For Managing Dry Eye

Medevac Use Oxygen Generator

FDA classification

FDA Class 2 ·Medevac Use Oxygen Generator

Biological Sterilization Indicator With Indirect Growth Detection

FDA classification

FDA Class 2 ·Biological Sterilization Indicator With Indirect Growth Detection

Digital Pathology Image Viewing And Management Software

FDA classification

FDA Class 2 ·Digital Pathology Image Viewing And Management Software

Gastrointesinal Lesion Software Detection System

FDA classification

FDA Class 2 ·Gastrointesinal Lesion Software Detection System

Integrated Continuous Glucose Monitoring System For Professional Retrospective Use

FDA classification

FDA Class 2 ·Integrated Continuous Glucose Monitoring System For Professional Retrospective Use

Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay

FDA classification

FDA Class 2 ·Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay

External Condom For Anal Intercourse Or Vaginal Intercourse

FDA classification

FDA Class 2 ·External Condom For Anal Intercourse Or Vaginal Intercourse

Active Implantable Bone Conduction Hearing System

FDA classification

FDA Class 2 ·Active Implantable Bone Conduction Hearing System

Image Acquisition And/Or Optimization Guided By Artificial Intelligence

FDA classification

FDA Class 2 ·Image Acquisition And/Or Optimization Guided By Artificial Intelligence

Hiv-1 Genotyping Assay Using Ngs Technology

FDA classification

FDA Class 2 ·Hiv-1 Genotyping Assay Using Ngs Technology

Cooperative Powered Surgical Assist Device For Ent Surgery

FDA classification

FDA Class 2 ·Cooperative Powered Surgical Assist Device For Ent Surgery