SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

DUREX PLAY TINGLING LUBRICANT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICROSULIS TISSUE ABLATION SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PALOMAR VECTUS LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACCUMESH DEPLOYMENT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NMI PICC III CATHETER, NMI HPICC III CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital

AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STRAUMANN MEMBRAGEL

FDA 510(k)

FDA Class 2 ·Dental

STRAUMANN MODIFIED DENTAL ABUTMENT

FDA 510(k)

FDA Class 2 ·Dental

CENTRIMAG DRAINAGE CANNULA KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BARRX FLEX RFA ENERGY GENERATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Cytosponge Cell Collection Device

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

2008K2 Hemodialysis Machine

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS

FDA 510(k)

FDA Class 2 ·Radiology

ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SURG-E-TROL SYSTEM I AND SYSTEM II

FDA 510(k)

FDA Class 2 ·Ophthalmic

OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765 72202766 72202767 72202768 72202769 72202770

FDA 510(k)

FDA Class 2 ·Orthopedic

PLTL-1 & PLDL-1 510NM PULSED DYE LASERS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery