ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

The Cooral System

FDA 510(k)

FDA Class 2 ·Dental

Chemo Mouthpiece

FDA 510(k)

FDA Class 2 ·Dental

Xandrine ren/qua/bei/bast Na/Var-F/Mi-L/Nu S

Device

EU MDR · Eu Md Class 1 ·Thanner GmbH·On the market

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D/Amplia MRI Quad CRT-D/ Brava CRT-D/Claria Quad CRT-D/ Brava Quad CRT-D/ Compia MRI Quad CRT-D/ Viva Qua

Intraoral Cooling Device

FDA classification

FDA Class 2 ·Intraoral Cooling Device

Auas Instruments.

Manufacturer

🇵🇰 Pakistan

Plantilla Duas Kft.

Manufacturer

🇭🇺 Hungary·1 Basic UDI-DI·1 Device

Aqua free GmbH

Manufacturer

🇩🇪 Germany

AQUA SURGICAL (PRIVATE) LIMITED

Manufacturer

🇵🇰 Pakistan

Mendec Aqua

FDA registration

TECRES SPA·1 product·🇮🇹 Italy

Aquas

FDA registration

Sterigenics U.S. LLC·1 product·🇺🇸 United States

Cryolab Limited

Manufacturer

6 Basic UDI-DIs·24 Devices

Aqua Lube Natural Patient Lubricant

FDA registration

MAYER LABORATORIES·1 product·🇺🇸 United States

pjur AQUA

FDA registration

pjur group Luxembourg S.A.·1 product·🇱🇺 Luxembourg

pjur AQUA

FDA registration

BIO ENERGO W. Lohmann GmbH·1 product·🇩🇪 Germany

Dailies Aqua comfort Plus Toric

FDA registration

ANGEL EYE CENTRE LTD.·2 products·🇬🇧 United Kingdom

HSP 65A

FDA registration

AAREN SCIENTIFIC INC·1 product·🇺🇸 United States

pro aqua Diamantelektroden Produktion GmbH

Manufacturer

🇦🇹 Austria

Medical-Latex (DUA) Sdn. Bhd.

Manufacturer

🇲🇾 Malaysia·151 Basic UDI-DIs·192 Devices·6 Importers·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.