1,556 results · 27ms · Sources: EU EUDAMED, US FDA

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·EPIC + DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND THE MODEL 3307 V 4.6M SOFTWARE

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·TRILOGY/SOLUS II/PARAGON III/PHOENIX III

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·MODEL 3307 VERSION 2.4A PROGRAMMER SOFTWARE

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

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·INTEGRITY CORONARY STENT SYSTEMS

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval
FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis and AMS 700 Inflatable Penile Prosthesis with InhibiZone Treatment

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·AMS 800 Artificial Urinary Sphincter and AMS 800 Artificial Urinary Sphincter with InhibiZone Treatment