Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Siello S 45/53/60, Solia S 45/53/60, Siello T 53/60, Siello JT 45/53, Solia T 53/60, Solia JT 45/53, EFH-6F-W

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK(TM) ECD

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Siello S and Solia S, EFH-6F-W and DH IS-1/DF4

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

FDA Pre-Market Approval

FDA Class 3 ·LEAD FIXATION SLEEVE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·AID (R) B/BR HIGH VOLTAGE CABLES FOR ECD SYSTEMS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EFH-16; S60-K; S 60-J; S 60-S

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EFH-16; S 60-K; S 60-J; S 60-S

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·KAINOX VCS,DF1-C6HV,AND VARIOUS MODELS OF LINOX,EFH, AND PROTEGO LEADS

Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents

FDA Pre-Market Approval

FDA Class 3 ·Et Control

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Roche cobas EGFR Mutation Test, Roche cobas® DNA Sample Preparation Kit, cobas® EGFR Mutation Test v2, Roche cobas® cfD

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Selox ST/JT; Siello S; Solia S; Setrox S; Safio S; S 45-K/53-K; DH; DH IS-1/DF4; EFH-6F-W; S53-K; S 45-S; S 53-S; S 45-F

Iliac Covered Stent, Arterial

FDA classification

FDA Class 3 ·Iliac Covered Stent, Arterial

Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents

FDA classification

FDA Class 3 ·Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents

Covered Stent Vascular Connector, Hemodialysis Access Circuit

FDA classification

FDA Class 3 ·Covered Stent Vascular Connector, Hemodialysis Access Circuit

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ORTHOPAK II BONE GROWTH STIMULATOR

Pediatric Esophageal Atresia Anastomosis Device

FDA classification

FDA Class 3 ·Pediatric Esophageal Atresia Anastomosis Device