3,824 results · 20ms · Sources: EU EUDAMED, US FDA

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC MODEL 2490C & 2490R CARELINK MONITORS

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart System

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·AXSYM HBSAG

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval
FDA Class 3 ·Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval
FDA Class 3 ·Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·VALITUDE™ CRT-P, VALITUDE™ X4 CRT-P, VISIONIST™ CRT-P, VISIONIST™ X4 CRT-P

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·EverFlex™ Self-Expanding Peripheral Stent System, 2 EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Sys

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ESSENTIO™ MRI SR, ESSENTIO™ MRI DR, ESSENTIO™ MRI EL DR, PROPONENT, ACCOLADE™ MRI SR, ACCOLADE™ MRI DR, ACCOLADE™ MRI EL

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·Protégé™ GPS™ Self-Expanding Peripheral Stent System

Stent, Iliac Vein

FDA Pre-Market Approval
FDA Class 3 ·Abre Venous Self-expanding Stent System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ESSENTIO™ SR, ESSENTIO™ DR, ESSENTIO™ EL DR, PROPONENT™ SR, PROPONENT™ DR, PROPONENT™ EL DR, ACCOLADE™ SR, ACCOLADE™ DR,

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·MINERVA ENDOMETRIAL ABLATION SYSTEM

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·Protégé™ GPS™ Self-Expanding Peripheral Stent System, and Protégé™ RX Carotid Stent System

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MODEL 7220 B/C/D/E JEWEL(R) PLUS, 7202 D/E, 7219 BDE, 7221 B/C/CXDE

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

FDA Pre-Market Approval
FDA Class 3 ·Cobalt MRI CRT-D, Cobalt XT MRI CRT-D and Crome MRI CRT-D

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD and Crome MRI ICD

Fluid, Hysteroscopy

FDA Pre-Market Approval
FDA Class 3 ·DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

FDA Pre-Market Approval
FDA Class 3 ·GENESEARCH BREAST LYMPH NODE ASSAY

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

FDA Pre-Market Approval
FDA Class 3 ·GENESEARCH BREAST LYMPH NODE