Merit Medical Systems, Inc. - FDA 510(k) Cleared Devices
Recent clearances: FlexTract Deflectable-Rotational Dilator Sheath Set, PreludeSYNC™ Radial Compression Device, StatSeal Disc
180
Total
172
Cleared
0
Denied
FDA 510(k) Regulatory Record - Merit Medical Systems, Inc. Cardiovascular ✕
118 devices
Cleared
Jul 27, 2026
FlexTract Deflectable-Rotational Dilator Sheath Set
Cardiovascular
97d
Cleared
Jul 22, 2026
PreludeSYNC™ Radial Compression Device
Cardiovascular
30d
Cleared
Apr 25, 2025
Prelude Wave Hydrophilic Sheath Introducer
Cardiovascular
30d
Cleared
Jan 15, 2025
Micro Ace Gold Advanced Micro Access System
Cardiovascular
169d
Cleared
Jan 15, 2025
Ventrax™ Delivery System
Cardiovascular
114d
Cleared
Dec 10, 2024
Prelude Small O.D. Introducer Guide Wire
Cardiovascular
195d
Cleared
May 22, 2024
Impress Angiographic Catheter
Cardiovascular
236d
Cleared
May 02, 2024
Siege Vascular Plug (SVP2.5-0.021)
Cardiovascular
92d
Cleared
Oct 28, 2023
Mighty Wire Guide Wire
Cardiovascular
254d
Cleared
Sep 27, 2023
Micro Ace™ Advanced Micro Access System
Cardiovascular
30d
Cleared
Aug 30, 2023
Ventrax™ Delivery System (VTR851)
Cardiovascular
121d
Cleared
Jan 19, 2023
Low Profile Companion Sheath
Cardiovascular
27d
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