SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

JLK-SDH

FDA 510(k)

FDA Class 2 ·Radiology

EGIS Biliary Single Bare Stent

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ULC SPINAL PEDICLE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ARIX HAND LOCKING SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

EPX-Series Mobile X-ray System

FDA 510(k)

FDA Class 2 ·Radiology

PathLoc SI Joint Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

Green Smart (Model: PHT-35LHS)

FDA 510(k)

FDA Class 2 ·Radiology

GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Tera Harz Clear

FDA 510(k)

FDA Class 2 ·Dental

R2GATE Lite TM

FDA 510(k)

FDA Class 2 ·Radiology

TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))

FDA 510(k)

FDA Class 2 ·General Hospital

ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Dentis I-FIX Abutment

FDA 510(k)

FDA Class 2 ·Dental

Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)

FDA 510(k)

FDA Class 2 ·Physical Medicine

STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

FDA 510(k)

FDA Class 2 ·General Hospital

Magicore Narrow System

FDA 510(k)

FDA Class 2 ·Dental

EsCem

FDA 510(k)

FDA Class 2 ·Dental

S-Mono

FDA 510(k)

FDA Class 2 ·Dental

X-Clever

FDA 510(k)

FDA Class 2 ·Radiology