52 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Device, Removal, Pacemaker Electrode, Percutaneous
FDA Pre-Market Approval
FDA Class 3
·SPECTRANETICS LASER SHEATH II PRODUCTS
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC ADAPTA, VERSA AND SENSIA IMPLANTABLE PULSE GENERATORS (IPG) PRODUCT FAMILY
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·GEL-ONE
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·RESTYLANE
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·RADIESSE DERMAL FILLER
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·RADIESSE, RADIESSE (+)
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·EVOLENCE COLLAGEN DERMAL FILLER
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·PROTECTA DF4 ICD, PROTECTA ICD, PROTECTA XT DF4 ICD, PROTECTA XT ICD
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·VERIFLEX (LIBERTE) CORONARY STENT SYSTEM
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·EXPRESS2 MONORAIL AND OTW CORONARY STENT SYSTEM
Stent, Renal
FDA Pre-Market Approval
FDA Class 3
·EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM
Stent, Superficial Femoral Artery
FDA Pre-Market Approval
FDA Class 3
·BioMimics 3D Vascular Stent System
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·RADIESSE
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·RESTYLANE, RESTYLANE-L, PERLANE, RESTYLANE LYFT, RESTYLANE SILK
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·RADIESSE, RADIESSE (+) [RADIESSE WITH LIDOCAINE]
System, Hemodynamic, Implantable
FDA Pre-Market Approval
FDA Class 3
·CARDIOMEMS HF SYSTEM
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·PROTEGO SD 60/16, PROTEGO SD 65/16, PROTEGO SD 65/18, PROTEGO SD 75/18, PROTEGO TD 65/16, PROTEGO TD 65/18, PROTEGO TD
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS TOTAL KNEE SYSTEM
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE