9,662 results
·
44ms
·
Sources: EU EUDAMED, US FDA
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·GEM VR MODELS 7227 B/D/E/CX
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ADVISA MRI
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP, GUARDIAN REAL-TIME MONITOR
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·SCIMED QUANTUM RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ANTI-HBS
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·SOF-SENSOR
Device, Angioplasty, Laser, Coronary
FDA Pre-Market Approval
FDA Class 3
·SPECTRANETICS CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·SJM EPIC VALVE AND SJM EPIC SUPRA VALVE
Lens, Multifocal Intraocular
FDA Pre-Market Approval
FDA Class 3
·ACRYSOF RESTOR NATURAL IOL MODELS SN60D3 AND MN60D3
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·GENESIS NEUROSTIMULATION (IPG) SYSTEM
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·CIBA CORNING ACS PSA IMMUNOASSAY
Respiratory Virus Panel Nucleic Acid Assay System
FDA classification
FDA Class 2
·Respiratory Virus Panel Nucleic Acid Assay System
Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
FDA classification
FDA Class 2
·Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
Vaginal Hydrogel Packing System
FDA classification
FDA Class 2
·Vaginal Hydrogel Packing System
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·THXID BRAF KIT
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS 700 Inflatable Penile Prosthesis, AMS 700 Inflatable Penile Prosthesis with InhibiZone, AMS Ambicor Inflatable Pe
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·(R) QUANTUM MONORAIL(TM) PTCA CATHETER