VIEW READING STATION

FDA 510(k)

FDA Class 2 ·Radiology

Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))

FDA 510(k)

FDA Class 2 ·Radiology

Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241

FDA 510(k)

FDA Class 2 ·General Hospital

Wearable breast pump (model W8)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Shoulder Arthroplasty Implantation System

FDA classification

FDA Class 2 ·Shoulder Arthroplasty Implantation System

Knee Arthroplasty Implantation System

FDA classification

FDA Class 2 ·Knee Arthroplasty Implantation System

Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed

FDA classification

FDA Class 2 ·Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

FDA classification

FDA Class 2 ·Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Pediatric/Child Facemask

FDA classification

FDA Class 2 ·Pediatric/Child Facemask

Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

FDA classification

FDA Class 2 ·Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

FDA classification

FDA Class 2 ·Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users

FDA classification

FDA Class 2 ·Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users

Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set

FDA classification

FDA Class 2 ·Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set

Monitor, St Segment With Alarm

FDA classification

FDA Class 2 ·Monitor, St Segment With Alarm

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

Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

FDA classification

FDA Class 2 ·Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

Defect Measurement Tool

FDA classification

FDA Class 2 ·Defect Measurement Tool

Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

FDA classification

FDA Class 2 ·Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

Red Dot

FDA 510(k)

FDA Class 2 ·Radiology

THAIRAPY(TM) BRONCHIAL DRAINAGE SYSTEM, MODEL 101

FDA 510(k)

FDA Class 2 ·Anesthesiology