HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW

FDA 510(k)

FDA Class 2 ·Radiology

SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CARDIO-VIEW

FDA 510(k)

FDA Class 2 ·Cardiovascular

TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital

CHEETAH NICOM SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Straumann® Anatomic Healing Abutments XC (AHA)

FDA 510(k)

FDA Class 2 ·Dental

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

MODEL I-2000 MONITOR

FDA 510(k)

FDA Class 2 ·Neurology

ULTRA-THIN SDS BALLOON DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NEXAN SYSTEM, MODEL NX-300

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

SKOUT® system

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MICROSELECTRON-HDR VERSION 2

FDA 510(k)

FDA Class 2 ·Radiology

AlignMATE™ Lapidus Arthrodesis System

FDA 510(k)

FDA Class 2 ·Orthopedic

Glidesheath

FDA 510(k)

FDA Class 2 ·Cardiovascular

REUSABLE MONOPOLAR FORCEPS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CUFFPATCH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery