OPTIBOND XTR

FDA 510(k)

FDA Class 2 ·Dental

SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DJ ORTHOPEDICS INTERFERENCE SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

FUKUDA DENSHI CARDIMAX FCP-211

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIOTROL LACTATE DEHYDROGENASE (L-P)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ENDOCARE PROLASE I ADVANCED LASER DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BODIHEALTH SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

KSEA ARTHROPUMP PLUS

FDA 510(k)

FDA Class 2 ·Orthopedic

HardyDisk AST Delafloxacin 5 µg (DLX5)

FDA 510(k)

FDA Class 2 ·Microbiology

HALO COAGULATION CATHETER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL

FDA 510(k)

FDA Class 2 ·General Hospital

VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001

FDA 510(k)

FDA Class 2 ·Radiology

GO GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

087 Balloon Guide Catheter System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Applied Medical Anoscope

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Oculus-SA Lumbar Cage System

FDA 510(k)

FDA Class 2 ·Orthopedic

µCor Heart Failure and Arrhythmia Management System

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICRUS MODIFIED MICROCOIL 18-SYSTEM, CERECYTE, MODEL CSP & CHE

FDA 510(k)

FDA Class 2 ·Neurology

ARTHROCARE SYSTEM 12000

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIPAP AUTOSV ADVANCED

FDA 510(k)

FDA Class 2 ·Anesthesiology