Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·THIN LINE AND FINELINE PACING LEADS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE(R) AND CAPSURE(R)SP LEADS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC CAPSURE(R) SP MODEL 5024M/5524M PACING LEADS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE SP/SENSE/SP NOVUS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·PHILOS PACING SYSTEM

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·PHILOS DR-T PULSE GENERATOR

PROCESS FOR PRF

Authorized representative

🇫🇷 France·1 Manufacturer

Walking table ALBE XXL to customize max 250kg

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Nordic activity AB·1 device

RA Walking table ALBE STANDARD RA max 130kg

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Nordic activity AB·1 device

Walking table ALBE – SMALL EL max 150 kg

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Nordic activity AB·1 device

Walking table ALBE – HR max 150 kg EL

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Nordic activity AB·1 device

Walking table ALBE – HR max 150 kg Gas

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Nordic activity AB·1 device

Nerve Capping Device

FDA 510(k)

FDA Class 2 ·Neurology

NASOPORE-FD

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

NEUROLAC(R) NERVE GUIDE

FDA 510(k)

FDA Class 2 ·Neurology

Titan Prime Universal HRP Polymer Detection Kit with DAB

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Lumatas BioSystems Inc·1 device

IMMCO DIAGNOSTICS

FDA UDI

IMMCO DIAGNOSTICS, INC.·00845714004179·Mounting Medium

IMMCO DIAGNOSTICS

FDA UDI

IMMCO DIAGNOSTICS, INC.·00845714004162·Mounting Medium

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PD-L1(SP142) CDX ASSAY