Sleep Apnea Feature

FDA 510(k)

FDA Class 2 ·Anesthesiology

INVIGRA

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Samsung ECG Monitor Application with Irregular Heart Rhythm Notification

FDA 510(k)

FDA Class 2 ·Cardiovascular

Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE

FDA 510(k)

FDA Class 2 ·General Hospital

Changer, Tube, Endotracheal

FDA Pre-Market Approval

FDA Class 2 ·ENDOTRACHEAL TUBE CHANGERS

Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff

FDA 510(k)

FDA Class 2 ·Cardiovascular

RS80A Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

RFMagik Lite

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Alinity m BKV

FDA 510(k)

FDA Class 2 ·Microbiology

cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

FDA 510(k)

FDA Class 2 ·Microbiology

IP-SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS

FDA 510(k)

FDA Class 2 ·Ophthalmic

Belun Ring BLR-200 (BLR-200)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ClearPath Aligner

FDA 510(k)

FDA Class 2 ·Dental

UTERINE TENACLUM HOOK

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Clear Moves Aligner

FDA 510(k)

FDA Class 2 ·Dental

Ensmile

FDA 510(k)

FDA Class 2 ·Dental

Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology