BrightHeart View Classifier

FDA 510(k)

FDA Class 2 ·Radiology

SoloSmart Injection Pen Adapter (SoloSmart®)

FDA 510(k)

FDA Class 2 ·General Hospital

PASS LP Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

U-Lite

FDA 510(k)

FDA Class 2 ·Radiology

IMMOBILIZATION SYSTEM FOR ENT

FDA 510(k)

FDA Class 2 ·Radiology

CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES

FDA 510(k)

FDA Class 2 ·Cardiovascular

STA R Max 3, STA Compact Max 3

FDA 510(k)

FDA Class 2 ·Hematology

spineEOS

FDA 510(k)

FDA Class 2 ·Radiology

FastStroke, CT Perfusion 4D

FDA 510(k)

FDA Class 2 ·Radiology

SPECTACLE FRAMES

FDA 510(k)

FDA Class 1 ·Ophthalmic

FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)

FDA 510(k)

FDA Class 2 ·Radiology

UNITY HUMERAL PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

RAPIDEC CARBA NP

FDA 510(k)

FDA Class 2 ·Microbiology

Pixyl.Neuro

FDA 510(k)

FDA Class 2 ·Radiology

TITANIUM TELEGRAPH HUMERAL NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

Aequalis Ascend Flex Shoulder System

FDA 510(k)

FDA Class 2 ·Orthopedic

ROSA ONE Brain Application

FDA 510(k)

FDA Class 2 ·Neurology

WITHINGS BLOOD PRESURE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

TELEGRAPH® EVOLUTION Humeral Nailing System

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO FIDIS VASCULITIS, MODEL MX007

FDA 510(k)

FDA Class 2 ·Immunology