UltraSight AI Guidance

FDA 510(k)

FDA Class 2 ·Radiology

First To Know Syphilis Test

FDA 510(k)

FDA Class 2 ·Microbiology

HOTWIRE™ RF Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE

FDA 510(k)

FDA Class 2 ·Ophthalmic

PASTURE, MODELS: F550, A520

FDA 510(k)

FDA Class 2 ·General Hospital

3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR

FDA 510(k)

FDA Class 2 ·General Hospital

Visby Medical Women's Sexual Health Test

FDA 510(k)

FDA Class 2 ·Microbiology

Colibrí

FDA 510(k)

FDA Class 2 ·Microbiology

DermaSensor

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BD Kiestra IdentifA

FDA 510(k)

FDA Class 2 ·Microbiology

BD Kiestra IdentifA

FDA 510(k)

FDA Class 2 ·Microbiology

Colibri System

FDA 510(k)

FDA Class 2 ·Microbiology

ACTIPROTECT UC N95 RESPIRATOR

FDA 510(k)

FDA Class 2 ·General Hospital

Wheelchair, Stair Climbing

FDA classification

FDA Class 2 ·Wheelchair, Stair Climbing

Ventilator, Emergency, Manual (Resuscitator)

FDA classification

FDA Class 2 ·Ventilator, Emergency, Manual (Resuscitator)

Stimulator, Nerve, Ac-Powered

FDA classification

FDA Class 2 ·Stimulator, Nerve, Ac-Powered

Teal Wand

FDA 510(k)

FDA Class 2 ·Microbiology

Red-Cell Count By Photometry

FDA classification

FDA Class 2 ·Red-Cell Count By Photometry

Rinse, Oral, Antibacterial (By Physical Means)

FDA classification

FDA Class 2 ·Rinse, Oral, Antibacterial (By Physical Means)

Image Acquisition And/Or Optimization Guided By Artificial Intelligence

FDA classification

FDA Class 2 ·Image Acquisition And/Or Optimization Guided By Artificial Intelligence