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

HEMODIALYSIS TUBING SETS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HEMOSIL FACTOR II DEFICIENT PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

E3 and Profile

FDA 510(k)

FDA Class 2 ·Neurology

TRELLIS-8 PERIPHERAL INFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT

FDA 510(k)

FDA Class 2 ·Orthopedic

GEKO

FDA 510(k)

FDA Class 2 ·Physical Medicine

SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIS/SEMI-RIGID AND FLEXIBLE MANUAL INSTRUMENTS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AVANCE FOAM DRESSING KITS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

WallFlex Biliary RX Fully Covered Stent System RMV

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000

FDA 510(k)

FDA Class 2 ·Orthopedic

CorMatrix Tyke

FDA 510(k)

FDA Class 2 ·Cardiovascular