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

1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes

FDA 510(k)

FDA Class 2 ·Neurology

KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION)

FDA 510(k)

FDA Class 2 ·Ophthalmic

HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System

FDA 510(k)

FDA Class 2 ·Physical Medicine

CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TOTAL SHIELD SURGICAL;TOGA(REGULAR, LARGE,X-LARGE);HOOD; HELMET ADVANCED HELMET W/LED LIGHTING, TOTAL SHIELD ACCESSORIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Orthodontic Led Accessory

FDA classification

FDA Class 2 ·Orthodontic Led Accessory

Led Light Source

FDA classification

FDA Class 2 ·Led Light Source

VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DUET (CONDOMS)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Q Guidance System; Mako Spine System;

FDA 510(k)

FDA Class 2 ·Neurology

MitraClip G4 Steerable Guide Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment

FDA 510(k)

FDA Class 2 ·Orthopedic