GO-PEN®

FDA 510(k)

FDA Class 2 ·General Hospital

Diode Laser Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Intensity Pulsed Light Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)

FDA 510(k)

FDA Class 2 ·Physical Medicine

VISTA DIGITAL OPTHALMOSCOPE

FDA 510(k)

FDA Class 2 ·Ophthalmic

GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C

FDA 510(k)

FDA Class 2 ·General Hospital

Diode Laser 808nm

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Multi-modality workstation

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·ATA SOFTWARE CARTRIDGE (SWM 1000 I-KTB.0.U)

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ANTI-CARCINOEMBRYONIC ANTIGEN (GOAT) CEA RIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ENZYMUN TEST{R} CEA

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·BELOS VR-T ICD

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE TEST KIT

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA TEST KIT

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE(R) EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA KIT

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD'S)

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE TEST KIT