GM85

FDA 510(k)

FDA Class 2 ·Radiology

SARNS 7850 CENTRIFUGAL PUMP (MODIFIED)

FDA 510(k)

FDA Class 2 ·Cardiovascular

COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS

FDA 510(k)

FDA Class 2 ·Cardiovascular

WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE

FDA 510(k)

FDA Class 2 ·Dental

Biovitals Analytics Engine

FDA 510(k)

FDA Class 2 ·Cardiovascular

NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Monopolar Cord

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ZOOM Aspiration Pump

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CROSSLEAD 0.014inch

FDA 510(k)

FDA Class 2 ·Cardiovascular

ASAHI Neurovascular Guide Wire CHIKAI X 014 soft

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIGITAL SCREENING AUDIOMETER DSA6214

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ASAHI TORNUS SUPPORT CATHETER WITH TORQUE DEVICE ACCESSORY

FDA 510(k)

FDA Class 2 ·Cardiovascular

Blue Eye

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

O2Vent Optima

FDA 510(k)

FDA Class 2 ·Dental

GUARDIAN INFLATABLE BONE EXPANDER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

COLIGN

FDA 510(k)

FDA Class 2 ·Cardiovascular

CliniCloud Non-contact Thermometer, Model SPL1024

FDA 510(k)

FDA Class 2 ·General Hospital

Polux , Minerva and Atropos PTA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

4CIS® Marlin ACIF Cage System

FDA 510(k)

FDA Class 2 ·Orthopedic