Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·DRILAC CUBES{TM}

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·DRILAC GRANULES

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·ELECTROMECHANICAL ENHANCEMENT TO DRIVER

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL Cochlear Implant

System, Imaging, Fluorescence

FDA Pre-Market Approval

FDA Class 3 ·KARL STORZ AUTOFLURESCENCE SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PreVue Pre-loaded System, IPURE Pre-loaded System

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 5076 LEAD

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL Cochlear Implant System

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·COMBI 40+ COCHLEAR IMPLANT SYSTEM

DCATS

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

ORTHO-THERM INFRARED SENSOR

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

FMS MODEL 110

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

VISITHERM

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

THERMOCOMP

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

GRAPHIC STRESS TELETHERMOMETRY

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

JEOL MODEL #JTG-500M

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

THERMOGRAPH, MEDICAL

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN/CONSULTA CRT-P/INSYNC III/SYNCRA CRT-P

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN STARFIX

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/PROTECTA XT/ICD/SECURA/VIRTUOSO II