9,662 results
·
42ms
·
Sources: EU EUDAMED, US FDA
Analyzer, Diagnostic, Fiber Optic (Colon)
FDA Pre-Market Approval
FDA Class 3
·WAVSTAT (TM) OPTICAL BIOPSY SYSTEM
Automated Insulin Dosing Device System, Single Hormonal Control
FDA Pre-Market Approval
FDA Class 3
·Medtronic MiniMed 670G System
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·RESTYLANE INJECTABLE GEL
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Senza Spinal Cord Stimulation (SCS) System
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·EXCLUDER AAA ENDOPROSTHESIS SIM-PULL
Agent, Absorbable Hemostatic, Non-Collagen Based
FDA Pre-Market Approval
FDA Class 3
·SURGICEL® Absorbable Hemostats
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC ON MODULAR ANALYTICS E170
Ventilator, High Frequency
FDA Pre-Market Approval
FDA Class 3
·LifePulse High Frequency Ventilator
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·AFX ENDOVASCULAR AAA SYSTEM
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE EXCLUDER AAA Endoprosthesis, GORE EXCLUDER Iliac Branch Endoprosthesis
Permanent Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·TENDRIL SDX PERMANENT PACEMAKER LEADS, MODELS 1688T/TC
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·Biomedics 55 Asphere (ocufilcon D) Soft (Hydrophilic) Contact Lenses Extended Wear
Sealant, Polymerizing
FDA Pre-Market Approval
FDA Class 3
·PROGEL PLEURAL AIR LEAK SEALANT, PROGEL EXTENDED APPLICATOR SPRAY TIP16CM/6IN, PROGEL EXTENDED APPLICATOR SPRAY TIP29CM/
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC INTERSTIM THERAPY SYSTEM FOR BOWEL
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS Total Knee System
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·Implantable System for Remodulin (ISR)
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEMS
Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·MiniMed 530G Insulin Pump
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·Gel-One
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·Paradigm REAL-Time Insulin Pump