CoverScan (CoverScan v1.1)

FDA 510(k)

FDA Class 2 ·Radiology

MRCP+ version 2 (MRCP+ v2)

FDA 510(k)

FDA Class 2 ·Radiology

VitruvianScan (v1.0)

FDA 510(k)

FDA Class 2 ·Radiology

LiverMultiScan

FDA 510(k)

FDA Class 2 ·Radiology

CoverScan v1

FDA 510(k)

FDA Class 2 ·Radiology

TOUCHLESS HOME-CATH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIAMED MODELS 600, 900, 960, 964

FDA 510(k)

FDA Class 2 ·Radiology

FEMALE EXTERNAL URINARY APPLIANCE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

URINARY DRAINAGE UNT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TOUCHLESS CLEAN-CATH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TOUCHLESS TM FOLEY CATHETER KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STERILE URETHRAL CATHETER KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE

FDA 510(k)

FDA Class 2 ·Anesthesiology

Platinum dRF Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

WARD-CSS (v1.2.x)

FDA 510(k)

FDA Class 2 ·Cardiovascular

All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AQUASOFT ALL-DAY & ALL-DAY T (HIOXIFILCON A) DAILY WEAR CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

ALL-BOND DENTIN BONDING SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

CUSHIONS, DENTURE ADHESIVE, ALL-DAY

FDA 510(k)

FDA Class 2 ·Dental