MIRARI® Cold Plasma System ( GV-M2-01)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

REPROCESSED EXTERNAL FIXATION DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

ACUTRON MENTOR MODEL 961

FDA 510(k)

FDA Class 2 ·Neurology

PSI-TEC LIPOSUCTION ASPIRATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GammaTile

FDA 510(k)

FDA Class 2 ·Radiology

MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVERY KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

GORE® Tri-Lobe Balloon Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

PSA ANTIBODY KIT

FDA 510(k)

FDA Class 2 ·Immunology

YUE PFONG SAFETY SYRINGE (3ML)

FDA 510(k)

FDA Class 2 ·General Hospital

SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GORE FLOW REVERSAL SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

FEP RINGED GORE-TEX STRETCH VASCUALR GRAFT WITH REMOVABLE RINGS

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICROSCREEN I HEARING TESTER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EDLEN IMAGING - GEMINI DUSB

FDA 510(k)

FDA Class 2 ·Dental

SureMAX Family of Cervical Spacers

FDA 510(k)

FDA Class 2 ·Orthopedic

EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic

BD Trek Powered Bone Biopsy System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ANTI-MUSCLE ACTIN PRIMARY ANTIBODY

FDA 510(k)

FDA Class 2 ·Immunology

COMPRESSION SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic