5008X Hemodialysis System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LIBERTY PDX CYCLER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CRIT-LINE III Blood Chamber II

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OmniPore DUROMAX Surgical Implants

FDA 510(k)

FDA Class 2 ·Dental

AquaA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TauTona Pneumoperitoneum Assist Device (TPAD)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ProteXsure Safety Capsule System

FDA 510(k)

FDA Class 2 ·General Hospital

AMBIO REMOTE HEALTH MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)

FDA 510(k)

FDA Class 2 ·General Hospital

QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)

FDA 510(k)

FDA Class 2 ·General Hospital

VPS Rhythm DLX Device with TipTracker Technology

FDA 510(k)

FDA Class 2 ·General Hospital

EverCrossTM 0.035 OTW PTA Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Clench Compression Staple

FDA 510(k)

FDA Class 2 ·Orthopedic

Able Medical Devices Valkyrie Thoracic Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Arrow Stiffening Stylet

FDA 510(k)

FDA Class 2 ·Cardiovascular

Kalitec Navigated Instrument System

FDA 510(k)

FDA Class 2 ·Neurology

UltraLase Flexible CO2 Laser Waveguide

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·THE DISINTEGRATOR PLUS LANCE/INSULIN NEEDLE DESTRUCTON DEVICE

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·THE DISINTEGRATOR INSULIN NEEDLE DESTRUCTION DEVICE