BEUDAMED
    82 results · 18ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·PHOSPHORYLCHOLINE (PC) COATED BIODIVYSIOH SV STENT PREMOUNTED ON AN OVER-THE-WIRE (OTW) DELIVERY SYST SV OTW), AND PC C)

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·FINELINE® II Sterox, FINELINE® II EZ Sterox, ACC SUP STABLZR 6220 US, ACC SUP STABLZR 6221 US

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·UNITY - C MODEL 292-06 PULSE GENERATOR & ACCS.

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·PHILOS DR ACC PACING SYSTEM AND PROGRAMMER SOFTWARE VERSION B-KAC.V.U/1

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·SELECTSECURE 3830

    Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

    FDA Pre-Market Approval
    FDA Class 3 ·GENESEARCH BREAST LYMPH NODE ASSAY

    Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

    FDA Pre-Market Approval
    FDA Class 3 ·GENESEARCH BREAST LYMPH NODE

    Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

    FDA Pre-Market Approval
    FDA Class 3 ·GENESEARCH BREAST LYMPH NODE (BLN) ASSAY

    Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

    FDA Pre-Market Approval
    FDA Class 3 ·GENESEARCH BREAST LYMPH NODE(BLN) ASSAY

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·SOLUS, ADDVENT, SOLUS II, SYNCHRONY, PHOENIX III, TRILOGY, AFFINITY, INTEGRITY, ENTITY, IDENTITY, VERITY AND VICTORY PAC

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·SOLUS, ADDVENT, SOLUS II, SYNCHRONY,PHOENIX III, TRIOLOGY, AFFINITY, INTREGRITY, ENTITY IDENTITY, VERITY AND VICTORY PAC

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ESSENTIO™ SR; ESSENTIO DR; ESSENTIO EL DR; PROPONENT™ SR; PROPONENT DR; PROPONENT EL DR; ACCOLADE™ SR; ACCOLADE DR; ACC

    Drug-Coated Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·IN.PACT AV Paclitaxel-Coated PTA Balloon Catheter

    Drug-Coated Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

    Drug-Coated Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

    Drug-Coated Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

    Drug-Coated Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·IN.PACT AV DCB

    Drug-Coated Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Lutonix 018 and 035 Drug Coated Balloon PTA Catheter

    Drug-Coated Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·LUTONIX® 035 Drug Coated Balloon PTA Catheter

    Drug-Coated Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter