Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ellipse, Fortify, Fortify Assura, Quadra Assura MP, Avant, Gallant, Entrant, Neutrino NxT

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

FDA Pre-Market Approval

FDA Class 3 ·Quadra Assura, Unify, Unify Assura, Unify Quadra, Avant, Gallant, Entrant, Neutrino NxT

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

FDA Pre-Market Approval

FDA Class 3 ·Avant HF, Neutrino NxT HF, Gallant HF and Entrant HF CRT-D

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

FDA Pre-Market Approval

FDA Class 3 ·Quadra Assura, Unify, Unify Assura, Unify Quadra, Avant, Gallant, Entrant, Neutrino NxT

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

FDA Pre-Market Approval

FDA Class 3 ·Avant, Entrant, Gallant, Neutrino NxT, Quadra Assura, Unify, Unify Assura, Unify Quadra

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ellipse, Fortify, Fortify Assura, Quadra Assura MP, Avant, Gallant, Entrant, Neutrino NxT

Vitreoretinal Cannulae (F11-B)

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Sterimedix Ltd·1 device

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR IMMUNOASSAY

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

FDA Pre-Market Approval

FDA Class 3 ·Avant CDHFA700Q, CDHFA700T; Neutrino NxT CDHFA800Q, CDHFA800T, CDHFA600Q, CDHFA600T; Gallant CDHFA500Q, CDHFA500T; Entra

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant CDVRA700Q, CDVRA700T Neutrino NxT CDVRA800Q, CDVRA800T, CDVRA600Q, CDVRA600T, Gallant CDVRA500Q, CDVRA500T Entrant

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE PATIENT MANAGEMENT SYSTEM, WAVE COMMUNICATOR MODEL 6290; NXT SYSTEM SEVER SOFTWARE MODEL 6460

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT AFP-EIA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avanta, Neutrino NXT, Gallant, Entrant VR ICD and Avant, Neutrino, Gallant and Entrant DR ICD

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

FDA Pre-Market Approval

FDA Class 3 ·Unify™, Unify Quadra™, Unify Assura™, Quadra Assura™, Quadra Assura MP™, Avant, Neutrino NxT, Gallant, Entrant

PEDIASAT

FDA UDI

Edwards Lifesciences LLC·00690103197532·PEDIASAT OXIMETRY CATHETER SET

PEDIASAT

FDA UDI

Edwards Lifesciences LLC·00690103197556·PEDIASAT OXIMETRY CATHETER KIT

PEDIASAT

FDA UDI

Edwards Lifesciences LLC·00690103197488·PEDIASAT OXIMETRY CATHETER SET

EV1000

FDA UDI

Edwards Lifesciences LLC·00690103190106·EV1000 MONITOR

PRESEP

FDA UDI

Edwards Lifesciences LLC·00690103176810·PRESEP OXIMETRY CATHETER 8.5F 16CM W/O THROMBOS...

PEDIASAT

FDA UDI

Edwards Lifesciences LLC·00690103197525·PEDIASAT OXIMETRY CATHETER SET