Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LifeVest Wearable Defibrillator

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DISPOSABLE EPG COVER

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DISPOSABLE EPG COVER

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·SCS EPG Header

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DISPOSABLE EPG COVER

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Deep Brain Stimulation (DBS) External Pulse Generator (EPG), Infinity DBS EPG Base

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Dorsal Root Ganglion (DRG) External Pulse Generator (EPG), Proclaim DRG EPG Base

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Spinal Cord Stimulation (SCS) External Pulse Generator (EPG), Proclaim SCS EPG Base

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

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DISPOSABLE EPG COVER/DISPOSABLE POUCH

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 5441 EPG PLASTIC COVER

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EPG-SINGLE AND DUAL CHAMBER

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System