FDA PMA medical devices

TorEx Lung Perfusion System Ref P250025

Traferox Technologies, Inc.CA Class III

RefluxStop® Device and RefluxStop® Deployment Tool Ref P250018

Implantica CE Reflux, Ltd.MT Class III

HepQuant SHUNT® Liver Diagnostic Test Ref P220016

Hepquant, LLCUS Class III

OncoMate® MSI Dx Analysis System Ref P250046

Promega CorporationUS Class III

VENTANA PTEN (SP218) RxDx Assay Ref P250031

Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)US

Belotero® Intense (+) Lidocaine Ref P250016

Merz North America, Inc.US Class III

AbsorbaSeal 5.6.7F Vascular Closure Device Ref P230038

Cyndrx, LLCUS Class III

PGDx elio tissue complete CDx Ref P250036

Personal Genome Diagnostics, Inc.US Class III

SimpleScreen™ CRC Ref P250029

Freenome, LLCUS Class III

AMDS Hybrid Prosthesis Ref P250055

Artivion, Inc.US Class III

Juveena Hydrogel System Ref P250051

Rejoni, Inc.US Class III

DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens Ref P220015

Tianjin Mastervision Technology Co., Ltd.CN Class III

Autus Size-Adjustable Valve Ref P260007

Edwards Lifesciences LLCUS Class III

LungFX™ device Ref P240033

Lung Bioengineering, Inc.US Class III

saypha® ChiQ™ Ref P250021

Croma-Pharma GmbHUS Class III

BAGUERA®C Cervical Disc Prosthesis Ref P250042

Spineart USA, Inc.US Class III

SELUTION SLR™ 014 PTCA Drug-Eluting Balloon Ref P250041

Medalliance, LLCUS Class III

Liverty™ TIPS Stent Graft Ref P250050

Bard Peripheral VascularUS Class III

Belotero Volume (+) Lidocaine Ref P250020