HIGH PERFORMANCE CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EMS Sculpt Machine

FDA 510(k)

FDA Class 2 ·Physical Medicine

Bladeless Trocar – Artemis Lap Cannula

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NEUROLINK IP MODEL: PK1117

FDA 510(k)

FDA Class 2 ·Neurology

Natus Quantum

FDA 510(k)

FDA Class 2 ·Neurology

MDS-90 ARGON DYE LASER FOR DERMATOLOGY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Bladeless Trocar – Artemis Lap Cannula

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·SUNRISE TECHNOLOGIES HYPERION(TM) HOLMIUM LASER SYSTEM FOR LASER THERMAL KERATOPLASTY (LTK)

DiscCath Needle Set

FDA 510(k)

FDA Class 2 ·Anesthesiology

TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)

FDA 510(k)

FDA Class 2 ·Neurology

OmniTom Elite

FDA 510(k)

FDA Class 2 ·Radiology

BodyTom 64

FDA 510(k)

FDA Class 2 ·Radiology

OmniTom

FDA 510(k)

FDA Class 2 ·Radiology

NExCT 7

FDA 510(k)

FDA Class 2 ·Radiology

Molecular Transport Media - MTM

FDA 510(k)

FDA Class 2 ·Microbiology

Rapid Barostat Bag (RBB) Pump and Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator)

FDA 510(k)

FDA Class 2 ·Physical Medicine

SilverCoat Silicone Foley Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PatCom Distal Chip Endoscope

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat