Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·IDENTITY ADX XL DC,SR/ADX VDR/ADX XL DR,DR,SR/VERITY ADX XL VDR/ADX XL DR,DR,DC/ADX XLSR,SR,SC

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·IDENTITY PULSE GENERATOR MODEL DR 5370

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·MODEL 3307 V1.2A PROGRAMMER SOFTWARE FOR THE MODEL 3500/3510 PROGRAMMERS

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

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·SVS APEX APEX EXIMER LASER WORKSTATION

AMS SPHINCTER 800 URINARY PROSTHESIS

FDA 510(k)

FDA Class 3 ·Unknown

THE ARTIFICIAL URINARY SPHINCTER

FDA 510(k)

FDA Class 3 ·Unknown

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·SENOCLAIRE

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·SENOGRAPHE PRISTINA 3D

Device, Intrauterine, Contraceptive And Introducer

FDA classification

FDA Class 3 ·Device, Intrauterine, Contraceptive And Introducer

Prosthesis, Urethral Sphincter

FDA classification

FDA Class 3 ·Prosthesis, Urethral Sphincter