10,000 results · 28ms · Sources: EU EUDAMED, US FDA

LIFEPAK 300

FDA 510(k)
FDA Class 3 ·Cardiovascular

FAST-PATCH

FDA 510(k)
FDA Class 3 ·Cardiovascular

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·PASCAL Precision – Implant System (PASCAL Implant, 10mm), PASCAL Precision – Implant System (PASCAL Ace Implant, 5mm)

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·ACUITY X4 (Straight,Spiral S, Spiral L) Steroid-eluting, Coronary Venous, QUADRIPOLAR ACE/SENSE LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ACE HEADER, DEFIBRILLATION SUPPORT DEVICE (DISD), END CAP, EPICARDIAL PATCH LEAD, SIZING SLEEVE, UPSIZING SLEEVE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ACE HEADER, APPLICATION SOFTWARE, DEFRILLATION SUPPORT DEVICE (DISD) END CAP, EPICCARDIAL PATCH LEAD SIZILING SLEEVE UPS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ACE HEADER, CABLE, DEFIBRILLATION SUPPORT DEVICE (DISD), END CAP, EPICARDIAL PATCH LEAD, PATIENT MAGNET, UPSIZING SLEEVE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/ACCESSORY (UPSIZING SLEEVE)

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NCP Model 201 Programming Wand, VNS Therapy AspireHC Model 105 Generator, VNS Therapy AspireSR, Model 106 Generator

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EPICARDIAL TRANSVENE LEAD, CABLE HEADER, ACE HEADER, UPSIZING SLEEVE FOR HV LEAD DF-1, UPSIZING SLEEVE, END CAP

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EPICARDIAL TRANSVENE/CABLE/ACE HEADER/UPSIZING SLEEVE FOR HV LEAD DF-1/UPSIZING SLEEVE/LEAD END PIN CAP

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval
FDA Class 3 ·LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·Tridyne Vascular Sealant

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval
FDA Class 3 ·LIAISON QuantiFERON - TB Gold Plus and LIAISON XL Control QuantiFERON-TB Gold Plus

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·PROGEL Pleural Air Leak Sealant

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval
FDA Class 3 ·QUANTIFERON-TB GOLD IN-TUBE