Catalysts for $MMSI

Mevion Medical Systems, Inc. — S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) (510k cleared)

Merit Medical System, Inc. — Surfacer Inside-Out Access Catheter System (510k cleared)

Ventana Medical Systems, Inc. — CINtec PLUS Cytology (PMA supplement)

Merit Medical Systems, Inc. device recall (Cls II)

Ventana Medical Systems, Inc. — CINtec PLUS Cytology (PMA supplement)

Merit Medical Systems, Inc. device recall (Cls II)

Merit Medical Systems, Inc. — Resilience Fully Covered Esophageal Stent System (510k cleared)

Ventana Medical Systems, Inc. — VENTANA PD-L1 (SP263) ASSAY (PMA supplement)

Ventana Medical Systems, Inc. — VENTANA ALK (D5F3) CDX ASSAY (PMA supplement)

Philips Medical Systems, Inc. — HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) (PMA supplement)

Ventana Medical Systems, Inc. — PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (PMA supplement)

Ventana Medical Systems, Inc. — VENTANA FOLR1 (FOLR-2.1) RxDx Assay (PMA supplement)

Ventana Medical Systems, Inc. — VENTANA CLDN18 (43-14A) RxDx Assay (PMA supplement)

Ventana Medical Systems, Inc. — PATHWAY® Anti-c-KIT (9.7) Primary Antibody (PMA supplement)

Ventana Medical Systems, Inc. — VENTANA HER2 DualL ISH DNA Probe Cocktail (PMA supplement)

Ventana Medical Systems, Inc. — PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (PMA supplement)

Philips Medical Systems, Inc. — HeartStart Home Defibrillator (M5068A) and HeartStart Onsite Defibrillator (M5066A) (PMA supplement)

Varian Medical Systems, Inc. — CT/ MR Tandem and Ovoid Set (510k cleared)

Merit Medical Systems, Inc. — Prelude Wave Hydrophilic Sheath Introducer (510k cleared)

Varian Medical Systems, Inc. — Titanium Flexible Geometry FSD Applicator Set (GM11013400) (510k cleared)

Varian Medical Systems, Inc. — Identify (4.0) (510k cleared)

Draeger Medical Systems, Inc. — Babyroo TN300 (510k cleared)

Varian Medical Systems, Inc. — Embozene Color-Advanced Microspheres (510k cleared)

Merit Medical Systems, Inc. — Micro Ace Gold Advanced Micro Access System (510k cleared)

Merit Medical Systems, Inc. — Ventrax™ Delivery System (510k cleared)

Varian Medical Systems, Inc. — Mould Probe MR Safe (510k cleared)

Ventana Medical Systems, Inc. — Roche Digital Pathology Dx (510k cleared)

Varian Medical Systems, Inc. — ARIA Radiation Therapy Management System (18.1) (510k cleared)

Merit Medical Systems, Inc. — Prelude Small O.D. Introducer Guide Wire (510k cleared)

Ventana Medical Systems, Inc. — VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) (510k cleared)