CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS: 532 AND 1064 ND:YAG HANDPIECE ACCESSORIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Anesthesia Kit

FDA classification

FDA Class 2 ·Anesthesia Kit

HEMODIALYSIS TUBING SETS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Tissue Adhesive For The Topical Approximation Of Skin

FDA Pre-Market Approval

FDA Class 2 ·DERMABOND (A FORMULATION OF 2-OCTYL CYANOACRYLATE)

GEM HEART ONE/ONE+

FDA 510(k)

FDA Class 2 ·Cardiovascular

Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture,

FDA 510(k)

FDA Class 2 ·Orthopedic

MICRO THERM MT-500 & MT-600

FDA 510(k)

FDA Class 2 ·General Hospital

MICROTHERM MT-501 & MT-502

FDA 510(k)

FDA Class 2 ·General Hospital

CUFF, BLOOD PRESSURE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Devon 51

FDA 510(k)

FDA Class 2 ·Cardiovascular

Devon 52 Sequential Compression Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

Devon 24

FDA 510(k)

FDA Class 2 ·Cardiovascular

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE NORFLOXACIN

External Counterpulsation System, Soulaire

FDA 510(k)

FDA Class 2 ·Cardiovascular