95 results · 46ms · Sources: EU EUDAMED, US FDA

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·FINELINE II & THINLINE II

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ST. JUDE MEDICAL MECHANICAL HEART VALVE

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Valiant Captivia Stent Graft ith the Captivia Delivery System

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM, MED-EL INSERTION TEST DEVICE (ITD)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·TELIGEN FAMILY

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·COGNIS FAMILY

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS 1-Piece IOL; OptiBlue; Multifocal; Toric 1-Piece IOLs; TECNIS i Tee Preloaded Delivery System; Symfont Extended R

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·Elecsys free PSA Test System

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·Elecsys free PSA Test System

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·Elecsys free PSA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·Dimension TPSA Flex reagent cartridge (RF451)

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·IMMULITE/IMMULITE 1000 PSA & 1000 THIRD GENERATION PSA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·AIA-PACK PA PSA, ST AIA-PACK PA PSA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT AXSYM/TOTAL PSA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·ACCESS HYBRITECH PSA REAGENTS ACCESS IMMUNOASSAY SYSTEMS

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·Dimension Vista TPSA Flex reagent cartridge (K6451)

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·ACCESS HYBRITECH PSA ON THE SYNCHRON LXI 725 SYSTEM

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT AXSYM TOTAL PSA