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(TM) CORONARY BALLOON DILATATION CATHETER

Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES

FDA 510(k)

FDA Class 2 ·Dental

ELECTRON ARC THERAPY

FDA 510(k)

FDA Class 2 ·Radiology

Vivaer ARC Stylus

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BRAINLAB STEREOTACTIC ARC

FDA 510(k)

FDA Class 2 ·Neurology

ARC ADAPTER ASSEMBLY

FDA 510(k)

FDA Class 2 ·Neurology

ARC-EX System

FDA 510(k)

FDA Class 2 ·Physical Medicine

Arc Endocuff Vision

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BRC SOFTWARE PRODUCT

FDA 510(k)

FDA Class 2 ·Neurology

Accelerate Arc System

FDA 510(k)

FDA Class 2 ·Microbiology

ARC SURGICAL BONE REDUCTION SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

FILTERFLO H

FDA 510(k)

FDA Class 2 ·Anesthesiology

FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME)

FDA 510(k)

FDA Class 2 ·Anesthesiology

V-GUIDE FOR VENTRICULOSTOMIES

FDA 510(k)

FDA Class 2 ·Neurology

CIRCUIT GUARD

FDA 510(k)

FDA Class 2 ·Anesthesiology

ARC SURGICAL BIOTRAK PIN SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

THERMOFLO HCH, THERMOFLO FILTER

FDA 510(k)

FDA Class 2 ·Anesthesiology