3,824 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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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