System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection

FDA classification

FDA Class 2 ·System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection

Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide (C21h34brno2) Coating

FDA classification

FDA Class 2 ·Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide (C21h34brno2) Coating

Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis

FDA classification

FDA Class 2 ·Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis

Catheter Remote Control System

FDA classification

FDA Class 2 ·Catheter Remote Control System

Filler, Bone Void, Alterable Compound For Cranioplasty

FDA classification

FDA Class 2 ·Filler, Bone Void, Alterable Compound For Cranioplasty

Adjunctive Epicardial Vascular Physiologic Status Indicator

FDA classification

FDA Class 2 ·Adjunctive Epicardial Vascular Physiologic Status Indicator

Radiological Computer Assisted Detection/Diagnosis Software For Fracture

FDA classification

FDA Class 2 ·Radiological Computer Assisted Detection/Diagnosis Software For Fracture

Bcr/Abl1 Monitoring Test

FDA classification

FDA Class 2 ·Bcr/Abl1 Monitoring Test

Mechanical Ventilator

FDA classification

FDA Class 2 ·Mechanical Ventilator

Interoperable Automated Glycemic Controller, Insulin Suspend

FDA classification

FDA Class 2 ·Interoperable Automated Glycemic Controller, Insulin Suspend

Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

FDA classification

FDA Class 2 ·Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

Microbial Colony Image Assessment System

FDA classification

FDA Class 2 ·Microbial Colony Image Assessment System

Powered Laser Surgical Instrument

FDA classification

FDA Class 2 ·Powered Laser Surgical Instrument

Interoperable Automated Glycemic Controller

FDA classification

FDA Class 2 ·Interoperable Automated Glycemic Controller

Real Time Nucleic Acid Amplification System

FDA classification

FDA Class 2 ·Real Time Nucleic Acid Amplification System

X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device

FDA classification

FDA Class 2 ·X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device

Extracorporeal System For Carbon Dioxide Removal

FDA classification

FDA Class 2 ·Extracorporeal System For Carbon Dioxide Removal

Alternate Controller Enabled Insulin Infusion Pump

FDA classification

FDA Class 2 ·Alternate Controller Enabled Insulin Infusion Pump

Implantable Radio Frequency Transponder System

FDA classification

FDA Class 2 ·Implantable Radio Frequency Transponder System

Respirator, Surgical

FDA classification

FDA Class 2 ·Respirator, Surgical