536 results · 28ms · Sources: EU EUDAMED, US FDA

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