Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: OLO ×
445 results
25–48 of 445
Search insights Median review: 95d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
Cleared Mar 27, 2026
SYMPHONY Navigation Ready Instruments
K260240 · OLO
Medos International SARL
Orthopedic · 60d
Cleared Mar 26, 2026
REAL INTELLIGENCE™ CORI™
K260601 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 30d
Cleared Mar 25, 2026
CUVIS-joint (CJ150)
K252037 · OLO
Curexo, Inc.
Orthopedic · 268d
Cleared Mar 20, 2026
TiLink-L Navigation Instruments
K253604 · OLO
SurGenTec, LLC
Orthopedic · 122d
Cleared Mar 18, 2026
EUROPA™ Posterior Cervical Fusion Navigated Instruments
K253444 · OLO
MiRus, LLC
Orthopedic · 167d
Cleared Mar 17, 2026
Q Pedicle Instruments
K260546 · OLO
K2m, Inc.
Orthopedic · 27d
Cleared Mar 03, 2026
TMINI® Miniature Robotic System
K260010 · OLO
THINK Surgical, Inc.
Orthopedic · 60d
Cleared Feb 25, 2026
Mako Total Knee Application
K260222 · OLO
Mako Surgical Corp.
Orthopedic · 30d
Cleared Feb 20, 2026
“POINT” Kinguide Agile Hybrid Navigation System
K252989 · OLO
Point Robotics MedTech, Inc.
Orthopedic · 155d
Cleared Feb 19, 2026
Valence Robotic Navigation System
K252597 · OLO
Alphatec Spine, Inc.
Orthopedic · 188d
Cleared Feb 19, 2026
Spine Guidance 5.4 Software
K253623 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 93d
Cleared Feb 19, 2026
VERTICALE GPS Instruments
K254148 · OLO
Silony Medical GmbH
Orthopedic · 59d
Cleared Feb 12, 2026
Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application
K253381 · OLO
Medtronic Navigation, Inc.
Orthopedic · 135d
Cleared Feb 06, 2026
ROSA Knee System with UltraSound Imaging Platform (USIP)
K252058 · OLO
Balmoral Medical, LLC
Orthopedic · 220d
Cleared Feb 06, 2026
Spine Guidance 5.3 Software
K252871 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 149d
Cleared Feb 06, 2026
Q Interbody Instruments
K252873 · OLO
K2m, Inc.
Orthopedic · 149d
Cleared Feb 03, 2026
Navigation Module of the Cortium® System
K252087 · OLO
Ulrich Medical USA, Inc.
Orthopedic · 216d
Cleared Jan 23, 2026
POINT Kinguide Agile Robotic Arm Surgical Stereotactic System
K252755 · OLO
Point Robotics MedTech, Inc.
Orthopedic · 147d
Cleared Jan 12, 2026
DYNAMIS™ Navigation System
K252962 · OLO
Promethean Restorative, LLC
Orthopedic · 118d
Cleared Dec 22, 2025
TMINI Miniature Robotic System
K253661 · OLO
THINK Surgical, Inc.
Orthopedic · 32d
Cleared Dec 15, 2025
Paradigm System
K252950 · OLO
Proprio, Inc.
Orthopedic · 90d
Cleared Dec 05, 2025
REAL INTELLIGENCE™ CORI™ XT (CORI XT)
K252841 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 88d
Cleared Dec 04, 2025
Spineology Navigation Instruments
K251943 · OLO
Spineology, Inc.
Orthopedic · 163d
Cleared Nov 13, 2025
Rosa® Knee System
K251314 · OLO
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 199d