Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ANTERIOR CHAMBER INTRAOCULAR LENS (CATARACT)

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·AB-CORE K HEPATITIS B CORE ANTIGEN 125I

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·AB-CORE K HEPATITIS B CORE ANTIGEN 125I

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·AB-CORE K HEPATITIS B CORE ANTIGEN 125I

Kit, Assay, Estrogen Receptor

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT ER-ICA MONOCLONAL

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IC-8 Apthera Intraocular Lens

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IC-8 Apthera Intraocular Lens (IOL)

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IC-8 Apthera Intraocular Lens (IOL)

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IC-8 Apthera Intraocular Lens (IOL)

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IC-8 Apthera Intraocular Lens (IOL)

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IC-8 Apthera intraocular lens (IOL)

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IC-8 Apthera Intraocular Lens (IOL)

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IC-8 Apthera IOL Aperture Mask

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IC-8® Apthera™ Intraocular Lens (IOL)

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

FDA Pre-Market Approval

FDA Class 3 ·FINELINE® II Sterox, FINELINE® II EZ Sterox, ACC SUP STABLZR 6220 US, ACC SUP STABLZR 6221 US

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·UNITY - C MODEL 292-06 PULSE GENERATOR & ACCS.

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SELECTSECURE 3830

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PHILOS DR ACC PACING SYSTEM AND PROGRAMMER SOFTWARE VERSION B-KAC.V.U/1

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync™ Micra VR App, CareLink SmartSync™ Micra AV App