2,701 results · 34ms · Sources: EU EUDAMED, US FDA

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CROMAX HIGH SPEED TURBINE HANDPIECE

FDA 510(k)
FDA Class 1 ·Dental

STEREOTIX

FDA 510(k)
FDA Class 2 ·Radiology

DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

America Hears®

FDA UDI
HEARING LAB TECHNOLOGY, LLC·00810068830309·Elite HA Android Package - Grey

America Hears®

FDA UDI
HEARING LAB TECHNOLOGY, LLC·00810068830248·Pro HA Android Package - Grey

Engage

FDA UDI
HEARING LAB TECHNOLOGY, LLC·00812944027391·ENGAGE BTE RECHARGEABL GRAY ANDROID PKG

America Hears®

FDA UDI
HEARING LAB TECHNOLOGY, LLC·00810068830361·Pro Rechargeable HA Android Package - Grey

Pulmonary Valve Prosthesis Percutaneously Delivered

FDA Pre-Market Approval
Melody

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Hancock Valved Conduit Low Porosity

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Hancock Valved Conduit Modified Orifice

Pulmonary Valve Prosthesis Percutaneously Delivered

FDA Pre-Market Approval
Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2700TFX, 2800, 2800TFX, 3000, 3000TFX,6900, 6900P

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS BIOPROTHESIS, MODEL 2500P

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS, MODEL 2650

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS BIOPROSTHESIS, MODELS 2625

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS MODELS 6625LP AND 6625-ESR-LP

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·TRIFECTA VALVE, VALVE WITH GLIDE