536 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS 700 Implantable Penile Prosthesis with and without Inhibizone Treatment
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS Ambicor Inflatable Penile Prosthesis
Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection
FDA Pre-Market Approval
FDA Class 3
·GENESEARCH BREAST LYMPH NODE(BLN) ASSAY
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS 700 INFLATABLE PENILE PROSTHESIS
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·Resolute Onyx (RX), Resolute Onyx (OTW), Resolute Onyx (RX) (2.0mm), Resolute Onyx (OTW) (2.0mm), Onyx Frontier RX Zotar
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·COROX OTW STEROID LV LEAD MONITORING (COSMO)
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·Integrity Coronary Stent System RX and OTW
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·LIBERTE MR & OTW CORONARY STENT SYSTEM
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·EXPRESS MR & OTW CORONARY STENT SYSTEM
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·INTEGRITY RX & OTW CORONARY STENT SYSTEMS
Drug-Eluting Peripheral Transluminal Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·Stellarex 0.035 OTW Drug-coated Angioplasty Balloon
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·EXPRESS2 MONORAIL AND OTW CORONARY STENT SYSTEM
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·SITUS OTW UW28D LEFT VENTRICULAR PACING LEAD
Drug-Eluting Peripheral Transluminal Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·Stellarex 0.035 OTW Drug-coated Angioplasty Balloon
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·MULTI-LINK OTW ZETA CORONARY STENT SYSTEMS
Drug-Eluting Peripheral Transluminal Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·Stellarex 0.035 OTW Drug-coated Angioplasty Balloon
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·LIBERTE MR & OTW CORONARY STENT SYSTEM
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·Integrity Coronary Stent System Rx and OTW
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·EXPRESS2 MONORAIL AND OTW CORONARY STENT SYSTEM
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·LIBERTE MR & OTW CORONARY STENT SYSTEM