Caption Guidance

FDA 510(k)

FDA Class 2 ·Radiology

HeartFocus (V.1.1.1)

FDA 510(k)

FDA Class 2 ·Radiology

Cardiac Guidance

FDA 510(k)

FDA Class 2 ·Radiology

UltraSight AI Guidance

FDA 510(k)

FDA Class 2 ·Radiology

SLS CHROMOS 694 QD RUBY LASER TO BE RENAMED MEHL QD RUBY LASER SYSTEM FOR HAIR REMOVAL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TorqVue Low Profile Delivery Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

First To Know Syphilis Test

FDA 510(k)

FDA Class 2 ·Microbiology

AMPLATZER TorqVue 45x45 Delivery Sheath

FDA 510(k)

FDA Class 2 ·Cardiovascular

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