Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix MRI Lead

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CapSure Epicardial Pacing Lead

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CapSure Sense Lead, SP Novus Lead; Vitron Crystalline Lead

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D, Quard CRT-D; Brava CRT-D, Quard CRT-D; Claria MRI CRT-D, Quard CRT-DCompia MRI CRT-D, Quard CRT-D; Con

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra TPS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CapSure VDD 2 Lead; Vitatron Brilliant S+ vdd Lead

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Attain Ability Lead, Performa Lead

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE SP & CAPSURE Z

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SUREFIX

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

Device

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

ACCESSORY ESSENTIALS

FDA UDI

FGX INTERNATIONAL INC.·00887661276667·

IRONMAN

FDA UDI

FGX INTERNATIONAL INC.·00193033600733·

PANAMA JACK

FDA UDI

FGX INTERNATIONAL INC.·00193033550472·

SOLARGENICS

FDA UDI

FGX INTERNATIONAL INC.·00887661238689·

UNBRANDED

FDA UDI

FGX INTERNATIONAL INC.·00193033511862·

DISNEY

FDA UDI

FGX INTERNATIONAL INC.·00887661236708·

BODY GLOVE

FDA UDI

FGX INTERNATIONAL INC.·00193033203859·

SOLAR SHIELD

FDA UDI

FGX INTERNATIONAL INC.·00887661855169·

FOSTER GRANT

FDA UDI

FGX INTERNATIONAL INC.·00887661100689·

FOSTER GRANT

FDA UDI

FGX INTERNATIONAL INC.·00193033549391·