190 results · 18ms · Sources: EU EUDAMED, US FDA

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivey System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·NG3 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ORIGEN EL ICD: D050, D051, D052, D053 INOGEN EL ICD: D140, D141, D142,

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

FDA Pre-Market Approval
FDA Class 3 ·DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4, ORIGEN, ORIGEN X4 NG3 CRT-D; INCEPTA, ENERGEN, PUNCTUA PROGENY CRT-D

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

FDA Pre-Market Approval
FDA Class 3 ·NG3 CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D) DYNAGEN CRT-D: G150, G151, G154, X4 CRT-D; G156, G158 INOGEN

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ORIGEN EL, INOGEN EL, DYNAGEN EL NG3 ICD;ORIGEN MINI, INOGEN MINI, DYNAGEN MINI NG2.5 ICD; INCEPTA, ENERGEN, PUNCTUA PRO

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

FDA Pre-Market Approval
FDA Class 3 ·NG3 CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D). DYNAGEN CRT-D, X4 CRT-D; INOGEN CRT-D, X4 CRT-D; ORIGEN CRT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR, NG3 CRT-D DYNAGEN CRT-D & X4 CRT-D, INOGEN CRT-D & X4 CRT-D. ORIGEN CRT

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval
FDA Class 3 ·INFORM HER2 DUAL ISH DNA PROBE COCKTAIL

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA classification
FDA Class 3 ·Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval
FDA Class 3 ·INFORM HER2 DUAL ISH DNA PROBE COCKTAIL