Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTRITEX SPL/TVL LED SYSTEM/ADX LEAD

Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LED Therapy Device (Planar LED/Planar LED mini)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LIGHTFUSION LED SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GENESIS LED WANDS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

UltraLight LED System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PLEXA S 60, PLEXA SD 60/16, PLEXA PROMRI S 65, PLEXA PROMRI S 75, PLEXA PROMRI SD 65/16, PLEXA PROMRI SD 65/18, PLEXA PR

GENTLEWAVES LED PHOTOMODULATION DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LED Spectrum therapy instrument

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LED Light Therapy Device, KN-7000L

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LED Light Therapy Device, ELIXIR MD™

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CLAREBLEND LED PROBES MODEL# 7201-415, 7204-631, 7205-830

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Ovation iX Abdominal Stent Graft System

1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NEOCERA Advanced Barrier Cream

FDA 510(k)

FDA Unclassified ·Unknown

MitraClip G4 Steerable Guide Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular