THE VISONIC DOME(TM)

FDA 510(k)

FDA Class 2 ·Ophthalmic

BARD AMBULATORY PCA DRUG DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

FALCON IVF FOUR WELL PLATE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HYPERION LONG PULSED ND: YAG LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AMADEUS ADAPTIVE COMPRESSION THERAPY

FDA 510(k)

FDA Class 2 ·Cardiovascular

Additive Orthopaedics Locking Lattice Plate

FDA 510(k)

FDA Class 2 ·Orthopedic

STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LTN - LAPAROSCOPIC SURGICAL MESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Monterey AL Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT

FDA 510(k)

FDA Class 2 ·Cardiovascular

COBAS CORE FERRITIN EIA

FDA 510(k)

FDA Class 2 ·Immunology

ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT

FDA 510(k)

FDA Class 2 ·Radiology

StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EMDS CHEMISTRY CALIBRATORS, LEVELS I & II

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)

FDA 510(k)

FDA Class 2 ·Orthopedic

HEDROCEL ACETABULAR CAGE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL HYDROPHILIC CONTACT LENSE)

FDA 510(k)

FDA Class 2 ·Ophthalmic

ESCALATE LAMINOPLASTY SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

URETERAL STENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EMDS ALKALINE PHOSPHATASE (ALP) TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry