Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ARC(TM) BALLOON CORONARY DILATATION CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ORACLE MEGASONICS FIVE-64 PTCA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS

STARCERAM

FDA 510(k)

FDA Class 2 ·Dental

STARCERAM

FDA 510(k)

FDA Class 2 ·Dental

StarCeram® Z-Nature, StarCeram® Z-Smile

FDA 510(k)

FDA Class 2 ·Dental

ASPIRATION REVERSAL CONTROL (ARC) MODULE

FDA 510(k)

FDA Class 2 ·Ophthalmic

InSeca ARC Stylus, Aerin Console

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VHF ULTRASONIC ARC-SCAN SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ATOM 1 (MODEL: BRC 2200)

FDA 510(k)

FDA Class 2 ·Neurology

SARNS 8.0 SOFT ARC CANNULA

FDA 510(k)

FDA Class 2 ·Cardiovascular

XENON ARC ENDOSCOPE LIGHT SOURCE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GENII ARC SMART ARGON PROBE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OMNI ARC MONOBLOCK HIP STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

LIGHT SOURCE, ENDOSCOP, XENON ARC

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COMPUTED TOMOGRAPHY ORIENTED ROTARY ARC

FDA 510(k)

FDA Class 2 ·Neurology

LOS 3D VISION 100

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

XENON LIGHT SOURCE PES 1

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LOS 3D VISION 100

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODEL 5135 AUTO LP/FLASH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology