10,000 results
·
464ms
·
Sources: EU EUDAMED, US FDA
FDA Pre-Market Approval
NIR PREMOUNTED STENT SYSTEMS
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Kainox VCS; Linox TD 65/18 & 65/16; SD 75/18, 65/18, 65/18, 60/16; T65, S75,S65, S60; S DX 65/17; S DX 65/15; Protego DF
Stent, Carotid
FDA Pre-Market Approval
FDA Class 3
·CARTOID WALLSTENT MONORAIL ENDOPROSTHESIS
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·LADAR VISION EXCIMER LASER SYSTEM
Pulse-Generator, Program Module
FDA Pre-Market Approval
FDA Class 3
·MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER
Transcatheter Septal Occluder
FDA Pre-Market Approval
FDA Class 3
·AMPLATZER MUSCULAR VSD OCCLUDER
Antigen(Complexed),Prostate Specific,(Cpsa)
FDA Pre-Market Approval
FDA Class 3
·Adiva Centaur Complexed PSA (cPSA) Immunoassay and Atellica IM cPSA Immunoassay
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·RENEWAL
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·NUCLEUS COCHLEAR IMPLANT SYSTEM
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·FINELINE II / THINLINE II FAMILY OF LEADS
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·Y Adaptor/Extender Kit; HV Splitter/Adaptor Kit; Sprint Quattro Lead.
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ETI-AB-AUK PLUS Assay
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·AFFINITY, IDENTITY, INTEGRITY, AND FRONTIER FAMILY OF DEVICES
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·EXCOR Pediatric Ventricular Assist Device
Mr-Guided Focused Ultrasound System
FDA Pre-Market Approval
FDA Class 3
·Exablate 4000 (Exablate Neuro)
Artificial Iris
FDA Pre-Market Approval
FDA Class 3
·CustomFlex ArtificialIris
Prosthesis, Breast, Inflatable, Internal, Saline
FDA Pre-Market Approval
FDA Class 3
·NATRELLE Saline-Filled Breast Implants
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·Activa Deep Brain Stimulation Therapy System
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·CapSure SP, Z Novus Lead; Vitatron Impulse II Lead
Pulse-Generator, Single Chamber, Sensor Driven, Implantable
FDA Pre-Market Approval
FDA Class 3
·Microny family of Pacemakers