DIRECT DIGITIZER, REGIUS MODEL 190

FDA 510(k)

FDA Class 2 ·Radiology

REGIUS RS-1000, MEDICAL IMAGE PROCESSING WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ULTRA CARE (TM) NEUTRALIZING TABLET

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·UNPRESERVED CONSEPT-2 RINSING & NEUTRALIZING SOL.

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·PRECISION(TM) UV (VASURFILCON)

CPR MICROSHIELD II

FDA 510(k)

FDA Class 2 ·Anesthesiology

QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)

FDA 510(k)

FDA Class 2 ·Anesthesiology

CPR MICROMASK PLUS CATALOG NO 73-402

FDA 510(k)

FDA Class 2 ·Anesthesiology

EXHALATION VALVE

FDA 510(k)

FDA Class 2 ·Anesthesiology

BAWMED RESCUE MASK

FDA 510(k)

FDA Class 2 ·Anesthesiology

CLINICAL DATA SYSTEM (CAM) MODULE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CPR MASK

FDA 510(k)

FDA Class 2 ·Anesthesiology

HEX tanning booth

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SUNTANA SUNBED #SB-1 & SUNBRELLA #SU-1

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

WOLFF SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

T-32;T-40;T-44;T-52;T-72;TT-50

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MINI TIGHTROPE FT REPAIR KIT

FDA 510(k)

FDA Class 2 ·Orthopedic

CPROTECTOR 2000

FDA 510(k)

FDA Class 2 ·Anesthesiology