Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Attain Bipolar OTW Lead, OTW LV Lead; Serena, Solara Quadripolar CRT-P

COVID-19 MPX 1-Step N Gene PCR Lyo. CE-IVD. Tubo 96 Reacciones

Basic UDI-DI

EU IVDD · Eu Ivd General ·SISTEMAS GENOMICOS. S.L.·1 device

COVID-19 MPX 1-Step NGene PCR Lyo-L CE-IVD. Placa 96 Reacciones.

Basic UDI-DI

EU IVDD · Eu Ivd General ·SISTEMAS GENOMICOS. S.L.·1 device

COVID-19 MPX 1-Step NGene PCR Lyo-H CE-IVD. Placa 96 Reacciones.

Basic UDI-DI

EU IVDD · Eu Ivd General ·SISTEMAS GENOMICOS. S.L.·1 device

Lys Medical

System producer

🇧🇪 Belgium

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·KRONOS LV-T AND LUMAX 300/340 & 500/540 HF/HF-T

Lumax

FDA registration

BIOTRONIK, INC.·7 products·🇺🇸 United States

Lumax

FDA registration

BIOTRONIK SE & CO. KG·7 products·🇩🇪 Germany

Enzyme Immunoassay, Fetal Fibronectin

FDA classification

FDA Class 3 ·Enzyme Immunoassay, Fetal Fibronectin

Apparatus, Vestibular Analysis

FDA classification

FDA Unclassified ·Apparatus, Vestibular Analysis

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

FDA Pre-Market Approval

FDA Class 3 ·FINISHING WIRE UNIVERSAL

Disposable ECMO Set

Basic UDI-DI

EU MDR · Eu Md Class 2a ·CHINABRIDGE (SHENZHEN) MEDICAL TECHNOLOGY CO., LTD.·3 devices

Calcitonin(CLIA)、Calcitonin Calibrators

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

Flushing Tool, Merlin@home Transmitter Software, Durata Active Fixation Leads

FDA registration

ABBOTT MEDICAL·7 products·🇺🇸 United States

PRO-TECH DESIGN & MFG., INC.

FDA registration

PRO-TECH DESIGN & MFG., INC.·7 products·🇺🇸 United States

Flushing Tool, Merlin@home Transmitter Software, Durata Active Fixation Leads

FDA registration

Abbott Medical·7 products·🇺🇸 United States

Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.

FDA registration

Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.·7 products·🇭🇰 Hong Kong

Flushing Tool, Merlin@home Transmitter Software, Durata Active Fixation Leads

FDA registration

Abbott Medical·7 products·🇺🇸 United States

Flushing Tool, Merlin@home Transmitter Software, Durata Active Fixation Leads

FDA registration

ABBOTT MEDICAL·7 products·🇺🇸 United States