Pulse-Generator, Pacemaker, External

FDA Pre-Market Approval

FDA Class 2 ·BEDSIDE(TM) SINGLE CHAMBER, TXTERNAL PULSE GENERATOR, MODEL 4170

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval

FDA Class 2 ·DEKLENE(TM)

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HCV

Suture, Absorbable, Natural

FDA Pre-Market Approval

FDA Class 2 ·CHROMIC GUT SUTURE

Suture, Nonabsorbable, Silk

FDA Pre-Market Approval

FDA Class 2 ·NONABSORBABLE SURG. SUTURES, BRAIDED SILK

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BOSTON LENS(R) CLEANER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Atellica IM Hepatitis C (aHCV) Assay

NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

CANDELA INTRODUCER SHEATH SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ULTRABIO

FDA 510(k)

FDA Class 2 ·Radiology

LYSUS INFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTELLIBRIDGE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT

FDA 510(k)

FDA Class 2 ·Cardiovascular

AQUILEX FLUID CONTROL SYSTEM H112

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5

FDA 510(k)

FDA Class 2 ·Anesthesiology

Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Para-Fix External Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery