PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; InsightersTM Insight Workstation iS-PF1.

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

uDR 780i

FDA 510(k)

FDA Class 2 ·Radiology

PleuraFlow System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

uMR 580, uMR 588

FDA 510(k)

FDA Class 2 ·Radiology

uDR 592h, uDR 596i

FDA 510(k)

FDA Class 2 ·Radiology

uCT ATLAS with uWS-CT-Dual Energy Analysis

FDA 510(k)

FDA Class 2 ·Radiology

Electronic Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

PleuraFlow System with FlowGlide

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

uMR Omega with uWS-MR-MRS

FDA 510(k)

FDA Class 2 ·Radiology

Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)

FDA 510(k)

FDA Class 2 ·Radiology

CO2 Laser Therapy Machine

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

hCG One Step Pregnancy Test

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

uMI Panorama

FDA 510(k)

FDA Class 2 ·Radiology

AMSafe NeuFlo Needleless Connector

FDA 510(k)

FDA Class 2 ·General Hospital

PleuraFlow System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CARE FECAL OCCULT BLOOD TEST, MODEL KT313

FDA 510(k)

FDA Class 2 ·Hematology

ND YAG Q-switch Laser Therapy Machine

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery