Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)

FDA 510(k)

FDA Class 2 ·Radiology

IWT

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Barco NV·1 device

V-Lock Vitrification Starws- Yellow- VL-Y

FDA registration

ALLWIN MEDICAL DEVICES, INC.·1 product·🇺🇸 United States

Shield, Gonadal

FDA classification

FDA Class 1 ·Shield, Gonadal

ICT HCTS

Manufacturer

🇳🇱 Netherlands·1 Basic UDI-DI·1 Device

ICT-GROUP SRL

Manufacturer

🇮🇹 Italy

Worldwide Innovations & Technologies, Inc.

Manufacturer

🇺🇸 United States·3 Importers

IMT Analytics AG

Manufacturer

🇨🇭 Switzerland·2 Basic UDI-DIs·2 Devices·1 Importer

HWT - TEMPLATE

FDA registration

EPTAM WEST LLC·1 product·🇺🇸 United States

Tubliseal / EWT

FDA registration

SAMTRADE SUPPLIES INC.·1 product·🇨🇦 Canada

KERR EWT SEALER

FDA registration

E/T ENDODONTIC TECHNOLOGIES, LTD.·1 product·🇨🇦 Canada

Pulp Canal / EWT

FDA registration

SAMTRADE SUPPLIES INC.·1 product·🇨🇦 Canada

Dentium Co., Ltd (ICT Branch)

Manufacturer

🇰🇷 South Korea

EWTS Easy Wheelchair Trike Service

Manufacturer

🇳🇱 Netherlands·2 Basic UDI-DIs·2 Devices

WaterCheck RC; WaterCheck CP; WaterCheck 2; RenalCheck PX

FDA registration

IBT Scientific·1 product·🇺🇸 United States

WaterSoft 0-30+ ppm Water Hardness Test

FDA registration

IBT Scientific·1 product·🇺🇸 United States

Glutar Test 1; Forma Test

FDA registration

IBT Scientific·2 products·🇺🇸 United States

Peracid Test

FDA registration

IBT Scientific·2 products·🇺🇸 United States

QwikCheck™ Chemical Indicator

FDA registration

IBT Scientific·1 product·🇺🇸 United States

Pulp Canal Sealer EWT

FDA registration

Kerr Corporation·1 product·🇺🇸 United States