Clarus Medical, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Clarus Medical, LLC - FDA 510(k) Cleared Devices
Recent clearances: Digital ClarusScope System and Digital NeuroPEN System, Digital ClarusScope System, Digital ClarusScope System, Digital NeuroPEN System
10
Total
10
Cleared
0
Denied
Clarus Medical, LLC has 10 FDA 510(k) cleared medical devices. Based in Minneapolis, US.
Latest FDA clearance: May 2026. Active since 2001. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Clarus Medical, LLC Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Alan Vanhouten Biomedical Consulting and Alan Vanhouten Biomedical Consultant.
FDA 510(k) Regulatory Record - Clarus Medical, LLC
10 devices
Cleared
May 26, 2026
Digital ClarusScope System and Digital NeuroPEN System
Orthopedic
266d
Cleared
Apr 25, 2024
Digital ClarusScope System
Orthopedic
59d
Cleared
Nov 21, 2023
Digital ClarusScope System, Digital NeuroPEN System
Neurology
351d
Cleared
Mar 18, 2021
Clarus Peel-Away Introducer Sheath
Neurology
345d
Cleared
Apr 28, 2009
CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V
Anesthesiology
285d
Cleared
Jun 01, 2004
NUCLEOTOME PROBE SET, MODEL 21200
Orthopedic
54d
Cleared
May 11, 2004
LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY...
General & Plastic Surgery
83d
Cleared
Nov 05, 2002
CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER...
General & Plastic Surgery
91d
Cleared
Sep 03, 2002
CLARUS STRAIGHT FIRING LASER FIBER
General & Plastic Surgery
90d
Cleared
Dec 13, 2001
SPINE SCOPE, MODEL 2180
Orthopedic
216d