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

iNSIGHT Color Doppler Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

SUBDERMAL NEEDLE ELECTRODES

FDA 510(k)

FDA Class 2 ·Neurology

M. DIOR BRAND

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ACTIPROTECT UC N95 RESPIRATOR

FDA 510(k)

FDA Class 2 ·General Hospital

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·Interface CABLES, Navistar Electrophysiology Catheter, EZ Steer Nav Bi-Directional Electrophysiology Catheter, Navistar

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·NAVISTAR Electrophysiology Catheter, EZ Steer NAV Bi-Directional Electrophysiology Catheter, NAVISTAR RMT Electrophysiol

Teal Wand

FDA 510(k)

FDA Class 2 ·Microbiology

Algesimeter, Powered

FDA classification

FDA Class 2 ·Algesimeter, Powered

Magnetic Surgical System

FDA classification

FDA Class 2 ·Magnetic Surgical System

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

Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

FDA classification

FDA Class 2 ·Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

Respirator, N95, For Use By The General Public In Public Health Medical Emergencies

FDA classification

FDA Class 2 ·Respirator, N95, For Use By The General Public In Public Health Medical Emergencies

Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users

FDA classification

FDA Class 2 ·Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users