JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

ORTHODONTIC CERAMIC BRACKETS 1.1

FDA 510(k)

FDA Class 2 ·Dental

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER LITHOTRIPTER TRANSPORTABLE (DLT)

Catheter, Flow Directed

FDA Pre-Market Approval

FDA Class 2 ·VOYAGER OTW CORONARY DILATION CATHETER

Catheter, Flow Directed

FDA Pre-Market Approval

FDA Class 2 ·RX CHASSIS 3 CORONARY DILATATION CATHETER

Catheter, Flow Directed

FDA Pre-Market Approval

FDA Class 2 ·ESPRIT/CROSSAIL/OPENSAIL/POWERSAIL/HIGHSAIL CORONARY DILATION CATHETHERS

Catheter, Flow Directed

FDA Pre-Market Approval

FDA Class 2 ·HIGHSAIL CORONARY DILATATION CATHETERS

GYMFORM ABS & CORE

FDA 510(k)

FDA Class 2 ·Physical Medicine

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·ALGES(TM) (HEFILCON A) CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·ALGES(TM) (HEFILCON A) CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·ALGES(TM) (HEFILCON A) CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·ALGES(TM) (HEFILCON A) CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·ALGES(TM) (HEFILCON A) CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·ALGES(TM) (HEFILCON A) CONTACT LENS

ACCRAASSAY RID KITS

FDA 510(k)

FDA Class 2 ·Immunology

PULMO-MIST COMPRESSOR MODEL # 4323

FDA 510(k)

FDA Class 2 ·Anesthesiology

eXciteOSA with remote and eXciteOSA without remote

FDA 510(k)

FDA Class 2 ·Dental

3100 INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)

FDA 510(k)

FDA Class 2 ·Dental

3400 INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital