ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

J&S HDL CHOLESTEROL PRECIPITATING REAGENT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ULTRA-THIN SDS BALLOON DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TempSure System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

leva Pelvic Floor Trainer

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PULPDENT RESILUTE

FDA 510(k)

FDA Class 2 ·Dental

Fuse Gastroscopy System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SKOUT® system

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AlignMATE™ Lapidus Arthrodesis System

FDA 510(k)

FDA Class 2 ·Orthopedic

REUSABLE MONOPOLAR FORCEPS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CUFFPATCH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HYDRASORB(TM)

FDA 510(k)

FDA Class 2 ·Anesthesiology

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL

FDA 510(k)

FDA Class 2 ·Orthopedic

NOSOGARD FILTERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VIDAS TOXOPLASMA GONDII IGM ASSSAY

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO: ORLUS MINI SCREW

FDA 510(k)

FDA Class 2 ·Dental

Coolief Radiofrequency Generator (CRG) System

FDA 510(k)

FDA Class 2 ·Neurology

BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET

FDA 510(k)

FDA Class 2 ·Microbiology

PARADIS VASO SHIELD

FDA 510(k)

FDA Class 2 ·Cardiovascular