Fibroid Mapping Reviewer Application (FMRA)

FDA 510(k)

FDA Class 2 ·Radiology

EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only

FDA 510(k)

FDA Class 2 ·Neurology

VACORA 14G BIOPSY PROBES, MODELS VB14116, VB14138

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SIMPACT IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

IVENT 201

FDA 510(k)

FDA Class 2 ·Anesthesiology

RECOVERY G2 FILTER SYSTEM - FEMORAL DELIVERY KIT, MODEL RF-310F; JUGULAR/SUBCLAVAIN DELIVERY KIT, MODEL RF-320J

FDA 510(k)

FDA Class 2 ·Cardiovascular

BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO I VENT 201

FDA 510(k)

FDA Class 2 ·Anesthesiology

IVENT101

FDA 510(k)

FDA Class 2 ·Anesthesiology

IVENT 201 PORTABLE VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT

FDA 510(k)

FDA Class 2 ·Cardiovascular

DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Sterilizer, Soft-Lens, Thermal, Ac-Powered

FDA Pre-Market Approval

FDA Class 2 ·HYDROCURVE PATIENT DISINFECTION UNIT

Sterilizer, Soft-Lens, Thermal, Ac-Powered

FDA Pre-Market Approval

FDA Class 2 ·SOFT MATE(R) DW (HEFILICON A) CONTACT LENS

Sterilizer, Soft-Lens, Thermal, Ac-Powered

FDA Pre-Market Approval

FDA Class 2 ·HEATCASE(TM)

Device, Vascular, For Promoting Embolization

FDA Pre-Market Approval

FDA Class 2 ·MINI BALLOON

Sterilizer, Soft-Lens, Thermal, Ac-Powered

FDA Pre-Market Approval

FDA Class 2 ·MODEL NO. ALS-IV HEAT DISINFECTION UNIT

Device, Vascular, For Promoting Embolization

FDA Pre-Market Approval

FDA Class 2 ·MINI BALLOON