Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·INTEGRITY/BRADYCARDIA REFERENCE/PATIENT MANUAL

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·APPLICATION SOFTWARE MODEL 3307 (VERSION 4.1A)

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·VICTORY PULSE GENERATOR MODELS: XL DR 5816, DR 5810 AND SR 5610

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·APPLICATION SOFTWARE, BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC ICD, INSYNC

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·VENTRITEX ICD'S

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·ATLAS+ DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, AND MODEL 3307 V.4.5A SOFTWARE

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Dorsal Root Ganglion Stimulation (DRG) Implantable Pulse Generators (IPGs), leads, extensions, and accessories

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Dorsal Root Ganglion Stimulation (DRG) Implantable Pulse Generators (IPGs), leads, extensions, and accessories

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·St. Jude Medical Clinician Programmer Application, St. Jude Medical Patient Controller Application, Proclaim DRG Implant

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·SENOCLAIRE

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·SENOGRAPHE PRISTINA 3D

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Azure Astra Application, Azure S DR MRI IPG Azure S sR MRI IRG and Azure XT DR/SR MRI IPG

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval

FDA Class 3 ·Exablate Neuro, Exablate Prime, Exablate Transcranial MRgFUS, Exablate Model 4000, Exablate Neuravive

DJP UNIPOLAR

FDA 510(k)

FDA Class 3 ·Cardiovascular

EKG TRANSMITTER MODEL 5134

FDA 510(k)

FDA Class 3 ·Cardiovascular

HEARTSTART 1000S

FDA 510(k)

FDA Class 3 ·Cardiovascular

LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP

FDA 510(k)

FDA Class 3 ·Cardiovascular

EDP-20 PACEMAKER

FDA 510(k)

FDA Class 3 ·Cardiovascular

AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP

FDA 510(k)

FDA Class 3 ·Cardiovascular