493 results · 30ms · Sources: EU EUDAMED, US FDA

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·GUIDANT CONTAK RENEWAL FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEVICES

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·GUIDANT VITALITY FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·DISCOVERY/MERIDIAN

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application

Stimulator, Autonomic Nerve, Implanted (Depression)

FDA Pre-Market Approval
FDA Class 3 ·CYBERONICS VNS THERAPY SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·Tryton Side Branch Stent

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·TRYTON Side Branch Stent

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·Tryton Side Branch Stent

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·TRYTON Side Branch Stent

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·Tryton Side Branch Stent

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·TRYTON SIDE BRANCH STENT

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA Pre-Market Approval
FDA Class 3 ·AAV5 DetectCDx®

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA Pre-Market Approval
FDA Class 3 ·AAV5 DetectCDx

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·SENSAR 1-Piece IOL, TECNIS 1-Piece IOL, Preloaded TECNIS 1-Piece IOL, TECNIS Multiocal 1-Piece IOL, TECNIS Toric 1-Piece

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·PARADYM (VR/DR) 8750, PARADYM RF (VR/DR) 9750(ZL101),PARADYM RF (VR/DR) 9750 (ZL102),INTENSIA (VR/DR)

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

FDA Pre-Market Approval
FDA Class 3 ·PARADYM CRT-D 8750,PARADYM RF CRT-D 9750 (ZL101), PARADYM RF CRT-D 9750 (ZL 102) AND INTENSIA CRT-D

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SENSAR 1-Piece IOL; TECNIS 1-Piece IOL; TECNIS 1-Piece OptiBlue IOL; Preloaded TECNIS 1-Piece IOL

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS 1-PIECE IOL, TECNIS OPTIBLUE 1-PIECE, TECNIS MULTIFOCAL 1-PIECE IOL