TALON BALLOON DILATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRISMA DISPOSABLE ENDO-OCULAR PROBE

FDA 510(k)

FDA Class 2 ·Ophthalmic

FLEXIMA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CODMAN FLEXIBLE ENDOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODEL 8800 CARDIORESPIRATORY OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CONCORDE VBR SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MCL 30 DERMABLATE ER:YAG LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PROTECTIVE CAPS

FDA 510(k)

FDA Class 2 ·Dental

HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

SHASER V-MINI 2 HAIR REMOVAL SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

H&H EMERGENCY CRICOTHYROTOMY KIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

OZARK 46

FDA 510(k)

FDA Class 2 ·Dental

GENZYME DIRECT AMYLASE VERIFIER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)

FDA 510(k)

FDA Class 2 ·General Hospital

truFreeze System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TVC IMAGING SYSTEM, TVC INSIGHT CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WELL@HOME SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

BIS ENGINE

FDA 510(k)

FDA Class 2 ·Neurology