LDH REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CURITY 100% SILICONE IRRIGATION FOLEY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DEODORANT SLENDER REG. TAMPONS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

FDA 510(k)

FDA Class 2 ·Cardiovascular

TISSUE PATCH, TISSUE GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

FITNESS LOGGER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANTISERUM, HUMAN, IGA

FDA 510(k)

FDA Class 2 ·Immunology

ULTRA LOW POROSITY DACRON WOVEN PATCH

FDA 510(k)

FDA Class 2 ·Cardiovascular

ATRIUM'S HYBRID PTFE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MIS AURAL ACOUSTIC SCREENER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

SMOOTH STAPLE IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

ACCU-O-MATIC

FDA 510(k)

FDA Class 2 ·Neurology

FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMPRA CARBOFLO EPTFE VASCULAR GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ITC BUNJI COIL (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Neurology

CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVE

FDA 510(k)

FDA Class 2 ·Dental