Sol-Millennium Medical, Inc.

Manufacturer

🇺🇸 United States·56 Basic UDI-DIs·307 Devices·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

LiNA Medical AG

Manufacturer

🇨🇭 Switzerland

BIOPTRON AG

Manufacturer

🇨🇭 Switzerland

SM ENG CO.,LTD.

Manufacturer

🇰🇷 South Korea

SteriPack USA Limited LLC

Manufacturer

🇺🇸 United States

RFBio Co., Ltd

Manufacturer

🇰🇷 South Korea·3 Basic UDI-DIs·3 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PACEMAKER/ICD/CRT NON IMPLANTED COMPONENTS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PACEMAKER ICD CRT NON IMPLANTED COMPONENTS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PACEMAKER ICD CRT NON IMPLANTED COMPONENTS

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·PACEMAKER ICD CRT NON IMPLANTED COMPONENTS

Hangzhou Realy Tech Co.,Ltd.

Manufacturer

🇨🇳 China·128 Basic UDI-DIs·129 Devices·CeCert Sp. z o.o., CeCert Sp. z o.o., and CeCert Sp. z o.o.

Ambler

FDA registration

Ambler Surgical, LLC·1 product·🇺🇸 United States

Gulden

FDA registration

KATENA PRODUCTS, INC.·1 product·🇺🇸 United States

Sterigenics U.S., LLC

FDA registration

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

MEDPOR ATTRACTOR Magnetic Coupling System

FDA registration

STRYKER LEIBINGER GMBH & CO. KG·1 product·🇩🇪 Germany

Oximeter, ear

FDA registration

CBR ENTERPRISE LIMITED·1 product·🇭🇰 Hong Kong

Silicone Orbital Implants

FDA registration

FCI SAS·1 product·🇫🇷 France

Ceramisys Bioceramic Alumina Implant

FDA registration

CERAMISYS LTD·1 product·🇬🇧 United Kingdom

EZYPOR

FDA registration

FCI OPHTHALMICS, INC.·1 product·🇺🇸 United States

Egg Shaped Bioceramic Orbital Implant

FDA registration

FCI FRANCE CHIRURGIE INSTRUMENTATION·1 product·🇫🇷 France