CHRONOCOR IV MODEL 250

FDA 510(k)

FDA Class 2 ·Cardiovascular

Medtronic Model 5392 External Pulse Generator (EPG)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDTRONIC MODEL 546

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CYNERGY MODEL 184

FDA 510(k)

FDA Class 2 ·Cardiovascular

EXTERNAL DEMAND PACEMAKER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V

FDA 510(k)

FDA Class 2 ·Cardiovascular

PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

BioK TE

FDA registration

BIOLENS LAB·1 product·🇲🇦 Morocco

Protego

FDA registration

BIOTRONIK SE & CO. KG·5 products·🇩🇪 Germany

Linoxsmart

FDA registration

BIOTRONIK, INC.·5 products·🇺🇸 United States

Pulse-Generator, Pacemaker, External

FDA classification

FDA Class 2 ·Pulse-Generator, Pacemaker, External

BTE Technologies

Manufacturer

🇺🇸 United States·2 Importers

ATE-S

FDA registration

ANTONI CARLES, S.A.·1 product·🇪🇸 Spain

CHROMA ATE INC.

Manufacturer

🇹🇼 Taiwan·4 Basic UDI-DIs·11 Devices·1 Importer

Capri

FDA registration

BTE TECHNOLOGIES·1 product·🇺🇸 United States

EVJ

FDA registration

BTE TECHNOLOGIES·1 product·🇺🇸 United States

SunmedTM Inflation Device

FDA registration

Ates Distribution·1 product·🇨🇦 Canada

PrimusRS

FDA registration

BTE TECHNOLOGIES·1 product·🇺🇸 United States

OPN NC PTCA balloon

FDA registration

Ates Distribution·1 product·🇨🇦 Canada