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