10 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Selox ST/JT; Siello S; Solia S; Setrox S; Safio S; S 45-K/53-K; DH; DH IS-1/DF4; EFH-6F-W; S53-K; S 45-S; S 53-S; S 45-F
Intravascular Radiation Delivery System
FDA Pre-Market Approval
FDA Class 3
·GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM
Intravascular Radiation Delivery System
FDA Pre-Market Approval
FDA Class 3
·GALILEO(TM) INTRAVASCULAR RADIOTHERAPY SYSTEM
Intravascular Radiation Delivery System
FDA Pre-Market Approval
FDA Class 3
·GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·MODEL 2490C/G/H/J CARELINK REMOTE HOME MONITOR/2020A ANALYZER
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC 2490 A/C/D/E/G/H/J CARELINK MONITORS
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Siello S and Solia S, EFH-6F-W and DH IS-1/DF4
Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
FDA Pre-Market Approval
FDA Class 3
·BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
FDA Pre-Market Approval
FDA Class 3
·CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·DIMENSION FPSA FLEX REAGENT CARTRIDGE