LIFEBORNE INFANT RESUSCITATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

ARGON CONTINUOUS FLUSH DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Steerant™ Super Stiff Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

NxtGen Infant Transport Incubator

FDA 510(k)

FDA Class 2 ·General Hospital

Sculpsure

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LBI CATHETER SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Visual-ICE Cryoablation System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SomnaPatch

FDA 510(k)

FDA Class 2 ·Anesthesiology

Echo Bi-Metric Microplasty Line Extension

FDA 510(k)

FDA Class 2 ·Orthopedic

Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28

FDA 510(k)

FDA Class 2 ·Radiology

5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ELECTROSURGICAL GENERATOR SYSTEM, MODEL ES 3000

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TempSure

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

WALLSTENT TRACHEOBRONCHIAL PROSTHESIS MODIFICATION

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

UNIPOLAR TEMP. MYOCARDIAL HEART WIRE, MODEL 6490

FDA 510(k)

FDA Class 2 ·Cardiovascular

POWERPORT CLEARVUE SLIM IMPLANTABLE PORT

FDA 510(k)

FDA Class 2 ·General Hospital

QUATRO M FEMORAL COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65

FDA 510(k)

FDA Class 2 ·Cardiovascular

Elecsys PTH , Elecsys PTH STAT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry