Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled

FDA 510(k)

FDA Class 2 ·Cardiovascular

GELBFISH ENDO-VAC SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pantheris System

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Catheter, Peripheral, Atherectomy

FDA classification

FDA Class 2 ·Catheter, Peripheral, Atherectomy

BCW POWER ADVANTAGE WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

BCW 600 POWER WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

CMDR 2CW (Multiple models)

FDA 510(k)

FDA Class 2 ·Radiology

Nautilus VF ECMO Oxygenator

FDA 510(k)

FDA Class 2 ·Cardiovascular

MC3 Crescent Jugular Dual Lumen Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Nautilus Smart ECMO Module

FDA 510(k)

FDA Class 2 ·Cardiovascular

MC3 Vascular Access Kit 21030

FDA 510(k)

FDA Class 2 ·Cardiovascular

MC3 QuickFlow Dual Lumen Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MC3 Jugular Dual Lumen Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·CMW BONE CEMENT, CMW 1, CMW 1 RADIOPAQUE, CMW 2, AND CMW 3 BONE CEMENTS.

GLYCOMAT HAEMOGLOBIN ANALYSER

FDA 510(k)

FDA Class 2 ·Hematology

GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT

FDA 510(k)

FDA Class 2 ·Hematology

745 GLYCOMAT

FDA 510(k)

FDA Class 2 ·Hematology

UST-2266U-5 CW DOPPLER TRANSDUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular