ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003

FDA 510(k)

FDA Class 3 ·Cardiovascular

PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005

FDA 510(k)

FDA Class 3 ·Cardiovascular

OneStep Pediatric CPR Multi-Function Electrode

FDA 510(k)

FDA Class 3 ·Cardiovascular

CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel

FDA 510(k)

FDA Class 3 ·Cardiovascular

ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX

FDA 510(k)

FDA Class 3 ·Cardiovascular

ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES

FDA 510(k)

FDA Class 3 ·Cardiovascular

VENTRALITH I

FDA 510(k)

FDA Class 3 ·Cardiovascular

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA 2 supported by LATITUDE Consult

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA 2 supported by LATITUDE Consult

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ADVANTIO, INGENIO, VITALIO, FORMIO ESSENTIO, ACCOLADE, PROPONENT, AND ALTRUA 2 SUPPORTED BY LATITUDE CONSULT ONLY) (PACE

Mandibular Condyle Prosthesis

FDA classification

FDA Class 3 ·Mandibular Condyle Prosthesis

Stimulator, Intracerebral/Subcortical, Implanted

FDA classification

FDA Class 3 ·Stimulator, Intracerebral/Subcortical, Implanted

Joint, Temporomandibular, Implant

FDA classification

FDA Class 3 ·Joint, Temporomandibular, Implant

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·AED Plus and Fully Automatic AED Plus

Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented

FDA classification

FDA Class 3 ·Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ANEURX AAADVANTAGE STENT GRAFT WITH XCELERANT DELIVERY SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADAR VISION EXCIMER LASER SYSTEM

Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer

FDA classification

FDA Class 3 ·Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer

Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight

FDA classification

FDA Class 3 ·Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight