EDD

FDA 510(k)

FDA Class 2 ·Anesthesiology

ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

KALMATE MODEL 3A

FDA 510(k)

FDA Class 2 ·Neurology

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

HEMI-ARC SURGICAL NAVIGATOR

FDA 510(k)

FDA Class 2 ·Neurology

PLASMA ARC CURING SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

APEX ARC HIP STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

FLEX-NECK ARC CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ZYSTON ARC INTERBODY SPACER

FDA 510(k)

FDA Class 2 ·Orthopedic

APEX ARC HIP STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ARC-2F ACETABULAR CUP

FDA 510(k)

FDA Class 2 ·Orthopedic

APEX ARC HIP STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ACUBEAM, SUPER NOVA, DIO

FDA 510(k)

FDA Class 2 ·Physical Medicine

SUPER NOVA, ACUBEAM

FDA 510(k)

FDA Class 2 ·Physical Medicine

BRC SOFTWARE PRODUCT

FDA 510(k)

FDA Class 2 ·Neurology

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