Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PACEMAKER/ICD/CRT NON IMPLANTED COMPONENTS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PACEMAKER ICD CRT NON IMPLANTED COMPONENTS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PACEMAKER ICD CRT NON IMPLANTED COMPONENTS

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

FDA Pre-Market Approval

FDA Class 3 ·PACEMAKER ICD CRT NON IMPLANTED COMPONENTS

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

FDA Pre-Market Approval

FDA Class 3 ·Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR

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

FDA Pre-Market Approval

FDA Class 3 ·Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR

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

FDA Pre-Market Approval

FDA Class 3 ·Sentus ProMRI OTW QP S, Sentus ProMRI OTW QP S-xx/49, Sentus ProMRI OTW QP L, Sentus ProMRI OTW QP Lxx/49m, Evia HF, Evi

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

FDA Pre-Market Approval

FDA Class 3 ·Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR

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

FDA Pre-Market Approval

FDA Class 3 ·Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR

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

FDA Pre-Market Approval

FDA Class 3 ·Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR

S.A.F. ACETABULAR CUP

FDA 510(k)

FDA Class 3 ·Orthopedic

H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED

FDA 510(k)

FDA Class 3 ·Orthopedic

S.A.F. ACETABULAR CUP WITH POROUS COATING

FDA 510(k)

FDA Class 3 ·Orthopedic

SAMUELSON ACETABULAR CUP

FDA 510(k)

FDA Class 3 ·Orthopedic

SAMUELSON SCREWLOC CUP

FDA 510(k)

FDA Class 3 ·Orthopedic

CLX ACETABULAR CUP (WAGNER) FOR CEMENTLESS FIXAT.

FDA 510(k)

FDA Class 3 ·Orthopedic

SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX.

FDA 510(k)

FDA Class 3 ·Orthopedic

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·Straumann Emdogain

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VITATRON BRILLIANT S+VDD LEAD

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

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN BIPOLAR OTW LEAD , ATTAIN OTW LEAD