PEDIA-THOR THORACOSTOMY KIT

FDA 510(k)

FDA Class 2 ·General Hospital

20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RAPID-TRAK(TM) INTRODUCER SHEATH

FDA 510(k)

FDA Class 2 ·Cardiovascular

Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02

FDA 510(k)

FDA Class 2 ·Anesthesiology

EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS

FDA 510(k)

FDA Class 2 ·Radiology

Vector PTA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

STYLA MICROLASER AND STYLAORTHO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HUMAN IGA2 KIT FOR USE ON THE SPAPLUS

FDA 510(k)

FDA Class 2 ·Immunology

OSTA MAXIGRO AND REGIGRO

FDA 510(k)

FDA Class 2 ·Dental

SOFTLASE PRO, ORTHOLASE AND HYGIENELASE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CANDELA GENTLELASE II DERMATOLOGICAL LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Passio Pump Drainage System

FDA 510(k)

FDA Class 2 ·Cardiovascular

COMFY SERIES: EV-804, EV-805 & EV-806

FDA 510(k)

FDA Class 2 ·Neurology

MAS WITH OR WITHOUT SYRINGE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LIFECARE ELECTRODES

FDA 510(k)

FDA Class 2 ·Neurology

Ophthalmed Bending Laser Probes

FDA 510(k)

FDA Class 2 ·Ophthalmic

HUMAN IGD KIT FOR USE ON SPAPLUS

FDA 510(k)

FDA Class 2 ·Immunology

ENEMA KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

S*E*M*M-SET & C*U*R*T-SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

21 HEMATOLOGY REAGENTS

FDA 510(k)

FDA Class 2 ·Hematology