325 results · 17ms · Sources: EU EUDAMED, US FDA

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·KAPPA 700/600,650,800/900 FAMILY, SIGMA FAMILY, MEDTRONIC 350 SERIES, ENPILSE 2 FAMILY ENRHYTHM, ADAPTA/VERSA/SESIA FAM

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·EXPRESS SD RENAL PREMOUNTED STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·REBEL MONORAIL AND OVER THE WIRE PLATINUM CHROMIUM CORONARY STENT SYSTEM

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval
FDA Class 3 ·Plasmaflo OP-05W(A)

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RADIESSE INJECTABLE IMPLANT FOR SUB-DERMAL IMPLANTATION FOR RESTORARION AND OR/ CORRECTION OF THE SIGNS OF FACIAL FAT LO

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RADIESSE INJECTABLE IMPLANT FOR SUB-DERMAL IMPLANTATION FOR RESTORATION AND OR CORRECTION FOR THE SIGNS OF FACIAL FAT LO

Prosthesis, Testicular

FDA Pre-Market Approval
FDA Class 3 ·MENTOR SALINE-FILLED TESTICULAR PROSTHESIS

Prosthesis, Testicular

FDA Pre-Market Approval
FDA Class 3 ·TOROSA TESTICULAR PROSTHESIS

Prosthesis, Testicular

FDA Pre-Market Approval
FDA Class 3 ·SALINE-FILLED TESTICULAR PROSTHESIS

Prosthesis, Testicular

FDA Pre-Market Approval
FDA Class 3 ·COLOPLAST SALINE-FILLED TESTICULAR PROSTHESIS

Prosthesis, Testicular

FDA Pre-Market Approval
FDA Class 3 ·COLOPLAST SALINE-FILLED TESTICULAR IMPLANT

Prosthesis, Testicular

FDA Pre-Market Approval
FDA Class 3 ·Torosa Saline Filled Testicular Prosthesis

Prosthesis, Testicular

FDA Pre-Market Approval
FDA Class 3 ·SALINE FILLED TESTICULAR PROSTHESIS

Prosthesis, Testicular

FDA Pre-Market Approval
FDA Class 3 ·Coloplast Saline-Filled Testicular Prosthesis (Torosa)

Prosthesis, Testicular

FDA Pre-Market Approval
FDA Class 3 ·Torosa Saline Filled Testicular Prosthesis

Prosthesis, Testicular

FDA Pre-Market Approval
FDA Class 3 ·COLOPLAST SALINE-FILLED TESTICULAR PROSTHESIS

Prosthesis, Testicular

FDA Pre-Market Approval
FDA Class 3 ·Coloplast Saline-Filled Testicular Prosthesis (Torosa)

Prosthesis, Testicular

FDA Pre-Market Approval
FDA Class 3 ·MENTOR SALINE-FILLED TESTICULAR PROSTHESIS

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System™ (OCS™) Heart

Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System™ (OCS™) Lung