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4WEB Medical

FDA UDI
4web Medical·00812998035724·

4WEB Medical

FDA UDI
4web Medical·00812998036042·

4WEB Medical

FDA UDI
4web Medical·00812998035762·

4WEB Medical

FDA UDI
4web Medical·00812998035960·

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Teligen, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen, Resonate, Momentum, Vigilant, Perciva

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

FDA Pre-Market Approval
FDA Class 3 ·Invive, Intua, Visionist, Valitude

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Advantio, Ingenio, Vitalio, Formio, Essentio, Accolade, Proponent

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Ingenio MRI, Vitalio MRI, Formio MRI, Essentio MRI, Proponent MRI, Accolade MRI

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

FDA Pre-Market Approval
FDA Class 3 ·Cognis, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen, Resonate, Momentum, Vigiliant, Perciva

ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

HOMOCYSTEINE MICROTITER PLATE ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

HOMOCYSTEINE TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ABBOTT AXSYM HOMOCYSTEINE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

A/C ENZYMATIC HOMOCYSTEINE ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

HEMOSIL HOMOCYSTEINE AND CONTROLS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BIO-RAD HOMOCYSTEINE BY HPLC

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III

FDA 510(k)
FDA Class 2 ·Clinical Chemistry