BURANE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Moda-flx Hemodialysis System and Cartridge

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WAVELIGHT AURIGA

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C

FDA 510(k)

FDA Class 2 ·Radiology

Moda-flx Hemodialysis System™ Cartridge (102121-001 )

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MEDICAL ASSEMBLIES FILTER

FDA 510(k)

FDA Class 2 ·Anesthesiology

YOUNG D'GRANULATOR

FDA 510(k)

FDA Class 2 ·Dental

BURANE XL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ALLEGRO OCULYZER

FDA 510(k)

FDA Class 2 ·Ophthalmic

ActTrust

FDA 510(k)

FDA Class 2 ·Neurology

NuVasive NuvaLine Mobile App

FDA 510(k)

FDA Class 2 ·Radiology

.decimal Astroid Dosimetry App

FDA 510(k)

FDA Class 2 ·Radiology

syngo Ultrasound Apps Suite (sUSAS)

FDA 510(k)

FDA Class 2 ·Radiology

SINGLE USE MANUAL RESUSCITATORS

FDA 510(k)

FDA Class 2 ·Anesthesiology

MCT MEDICAL BROWNE UROSCAN URODYNAMIC

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Samsung ECG App v 1.3 (ECG)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Informed Vital Core Application (IVC App)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACCU-CHEK Connect Diabetes Management App

FDA 510(k)

FDA Class 2 ·Anesthesiology

ACCU-CHEK CONNECT DIABETES MANAGEMENT APP

FDA 510(k)

FDA Class 2 ·Anesthesiology

MDHearingAid app, MDHearingAid Smart hearing aids

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat