10,000 results · 52ms · Sources: EU EUDAMED, US FDA

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·P880086 Endurity PM1162, PM2162; Endurity Core PM1140, PM2140; AV Plus Dx Lead 1368; Verity ADx XL 5357M/S, 5356, 5256,

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CLARITY /VITATRON DA+ C-SERIES/DIAMOND 3/JADE 3/RUBY 3/VITATRON DA+ T-SERIES/TOPAZ 3/VITA 2/VITA IPGS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CLARITY/VITATRON DA+C-SERIES/DIAMOND 3/JADE 3/RUBY 3/VITATRON DA+T-SERIES/TOPAZ 3/VITA 2/VITA IPGS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CLARITY/DA+ C-SERIES/T-SERIES/DIAMOND 3/II/JADE 3/II/RUBY 3/II/SELECTION AFM/TOPAZ 3/II/VITA/2

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CLARITY/DA+C & T SERIES/DIAMOND 3/II/JADE 3/II/RUBY 3/II/ SELECTION AFM/TOPAZ 3/II/VITA/VITA 2

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·VENTANA PD-L1(SP142) CDX ASSAY

Immunohistochemistry Assay, Antibody, Met

FDA Pre-Market Approval
FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

Immunohistochemistry Assay, Antibody, Claudin 18

FDA Pre-Market Approval
FDA Class 3 ·VENTANA CLDN18 (43-14A) RxDx Assay

Immunohistochemistry Assay, Antibody, Folr1

FDA Pre-Market Approval
FDA Class 3 ·VENTANA FOLR1 (FOLR-2.1) RxDx Assay

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·VENTANA PD-L1 (SP142) Assay

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval
FDA Class 3 ·VENTANA MEDICAL SYSTEMS PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·VENTANA PD-L1 (SP263) ASSAY

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·VENTANA PD-L1(SP142) CDX ASSAY

Transvenous Temporary Phrenic Nerve Stimulator

FDA classification
FDA Class 3 ·Transvenous Temporary Phrenic Nerve Stimulator

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·VENTANA PD-L1(SP142) Assay.