MARK I HUMIDIFIER

FDA 510(k)

FDA Class 2 ·Anesthesiology

HOT SACK

FDA 510(k)

FDA Class 2 ·General Hospital

A-1 IN-HOME PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MINI-BEEP

FDA 510(k)

FDA Class 2 ·Physical Medicine

ACU-SLIDE TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK (SL) CAD

AxSOS 3 AF System and AxSOS 3 Ti System

FDA 510(k)

FDA Class 2 ·Orthopedic

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK ANALOG 6.0 COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY

Tek RMD (Tek Robotic Mobilization Device)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

BAUSCH & LOMB CLEANING PAD

FDA 510(k)

FDA Class 2 ·Ophthalmic

SR-8230, SR-8230S Portable X-ray Unit

FDA 510(k)

FDA Class 2 ·Radiology

Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

Disposable Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

U60 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

LED Facial Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CuringPen Dental Curing Light

FDA 510(k)

FDA Class 2 ·Dental