15 results · 18ms · Sources: EU EUDAMED, US FDA

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·Guardant360 CDx

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·Guardant360 CDx

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·BIODIVYSIO AS PS (PHOSPHORYLCHOLINE)COATED STENT DELIVERY SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·Ceramax Ceramic Total Hip System

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·Ceramax Ceramic Total Hip System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MODEL 3038 FUNCTION PACT FOR ASP-II 3003 PROGRAMME

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·MODEL 3038 FUNCTION PACK FOR ASP-II 3003 PROGRAMME

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·PROLIEVE THERMODILATATION SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bip

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·Edora 8 HF-T QP, Edora 8 HF-T/QP, Evity 8 HF-T/QP,Evity 8 HF-T/QP, Corox (ProMRI) OTW 85 BP, L85 BP, S 85 BP, Sentus (Pr

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM

Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation

FDA Pre-Market Approval
FDA Class 3 ·DEPUY PINNACLE COMPLETE ACETABULAR HIP SYSTEM

Warmer, Blood, Electromagnetic Radiation

FDA classification
FDA Class 3 ·Warmer, Blood, Electromagnetic Radiation