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

FDA Pre-Market Approval

FDA Class 3 ·Amplia, Brava, Claria , Compia, Converto, Maximo, Protecta, Viva

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval

FDA Class 3 ·MYCARELINK PATIENT MONITOR MODEL

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI, Evera XT DR ICD, Intrinsic 30 ICD, Marquis VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Virtuoso II

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·Senographe Pristina 3D

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

FDA Pre-Market Approval

FDA Class 3 ·Corox OTW BP/OTW-S BP; Corox OTW-L BP/ProMRI OTW-L BP; Corox ProMRI OTW BP/ProMRI OTW-SBP; Sentus ProMRI OTW QP S/ProMRI

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

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV/LV-T/COROX OTW (-S) BP/COROX OTW-L BP

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

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV/LV-T/COROX OTW (-S) BP/COROX OTW-L BP

Pulse-Generator, Program Module

FDA Pre-Market Approval

FDA Class 3 ·AORTIC VALVULOPLASTY BALLOON DILATATION CATHETER

Pulse-Generator, Program Module

FDA Pre-Market Approval

FDA Class 3 ·MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER

Pulse-Generator, Program Module

FDA Pre-Market Approval

FDA Class 3 ·MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER

Pulse-Generator, Program Module

FDA Pre-Market Approval

FDA Class 3 ·AORTIC VALVULOPLASTY BALLOON DILATATION CATHETER

Pulse-Generator, Program Module

FDA Pre-Market Approval

FDA Class 3 ·BOSTON SCITNTIFIC SCIMED AORTIC VALVULOPLASTY(TM) CATHETER

Pulse-Generator, Program Module

FDA Pre-Market Approval

FDA Class 3 ·MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER

Pulse-Generator, Program Module

FDA Pre-Market Approval

FDA Class 3 ·MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER

Pulse-Generator, Program Module

FDA Pre-Market Approval

FDA Class 3 ·AORTIC VALVULOPLASTY BALLOON DILATATION CATHETER

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval

FDA Class 3 ·EXABLATE

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval

FDA Class 3 ·EXABLATE 2000 SYSTEM

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval

FDA Class 3 ·InSightec ExAblate System

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval

FDA Class 3 ·EXABLATE 2000, VERSION 4.22