INFANT ELECTROSURGICAL GROUNDING PAD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CHUCK HANDLE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIPOLAR CARD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIGITRACE HOME VIDEO SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

FDA 510(k)

FDA Class 2 ·Dental

B4C System - Addition of new sensor model (BcSs-PICNIW-2000)

FDA 510(k)

FDA Class 2 ·Neurology

TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T)

FDA 510(k)

FDA Class 2 ·Anesthesiology

GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LYNX CONTOUR CORONARY BALLOON DILATATION CATHETER(A NEW MODEL OF THE FACT CATHETER).

BASAL DIGITAL THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

ULTRASONIC NEBULIZER (MESH TYPE)

FDA 510(k)

FDA Class 2 ·Anesthesiology

SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMS

FDA 510(k)

FDA Class 2 ·Radiology

CHALLENGER SUNRISE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBE

FDA 510(k)

FDA Class 2 ·Radiology

NON-CONTACT THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES

FDA 510(k)

FDA Class 2 ·Physical Medicine

SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSES

FDA 510(k)

FDA Class 2 ·Ophthalmic

GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery