QIR Suite

FDA 510(k)

FDA Class 2 ·Radiology

CARPEDIEM System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Pediatric Hemodialysis System

FDA classification

FDA Class 2 ·Pediatric Hemodialysis System

Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

sOLVe Tube

FDA 510(k)

FDA Class 2 ·Anesthesiology

Bonus Therapeutics Mixing and Delivery System

FDA 510(k)

FDA Class 2 ·General Hospital

METATECH METAL MICROCLIP

FDA 510(k)

FDA Class 2 ·Cardiovascular

LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System

FDA 510(k)

FDA Class 2 ·Physical Medicine

DU PONT PHENYTOIN ASSAY AND CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Tosama Biobased Applicator Tube Menstrual Tampon

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Laser Treatment System, Model: Hera, Armo

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EMS (FlexPulse, MagnaCore, Magnetika)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Co2 Laser System, Models: PureLase And VanLase

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Alexandrite and Nd:YAG Laser models CANLASE and TORLASE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Curing Light, Model: MaxCure 9

FDA 510(k)

FDA Class 2 ·Dental

Ultrasonic Scaler Tips

FDA 510(k)

FDA Class 2 ·Dental

TROPIC AIR HEAT-ECHANGER BREATHING AID

FDA 510(k)

FDA Class 2 ·Anesthesiology

IQ NASAL MASK, MODEL P/N 50160

FDA 510(k)

FDA Class 2 ·Anesthesiology