102 results · 19ms · Sources: EU EUDAMED, US FDA

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·ASPIRE Cristalle Breast Tomosynthesis System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Consulta CRT-P, Syncra CRT-P, Viva CRT-P

Leadless Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·MICRA TRANSCATHETER PACEMAKER SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Adapta, Versa, Sensia IPGEnPulse E1 IPG Kappa DR (Kappa 700/600)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·REVO MRI SURESCAN IPG

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

FDA Pre-Market Approval
FDA Class 3 ·Amplia, Brava, Claria , Compia, Converto, Maximo, Protecta, Viva

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·MYCARELINK PATIENT MONITOR MODEL

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Evera MRI, Evera XT DR ICD, Intrinsic 30 ICD, Marquis VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Virtuoso II

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·Senographe Pristina 3D

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·SENOCLAIRE

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·MAMMOMAT Revelation with Tomosynthesis Option System

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval
FDA Class 3 ·INTERPORE PRO OSTEAN(R)IMPLANT 500 COR. HYDROX

Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

FDA Pre-Market Approval
FDA Class 3 ·NATURAL-KNEE(R) WITH CSTI(TM)

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval
FDA Class 3 ·COLLAGRAFT STRIP BONE GRAFT MATRIX

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval
FDA Class 3 ·COLLAGRAFT(TM) BONE GRAFT SUBSTITUTE

Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

FDA Pre-Market Approval
FDA Class 3 ·NATURAL-KNEE AND NATURAL-KNEE II