FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: OLO ×
439 results
25–48 of 439
Search insights Median review: 97d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
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
Cleared Nov 05, 2025
ExcelsiusGPS™ Instruments
K250599 · OLO
Globus Medical, Inc.
Orthopedic · 250d
Cleared Oct 31, 2025
Firebird SI Navigation System
K252088 · OLO
Orthofix US, LLC
Orthopedic · 121d
Cleared Oct 28, 2025
Navigated Instruments
K252742 · OLO
Tyber Medical, LLC
Orthopedic · 61d
Cleared Oct 27, 2025
OsteoCentric Navigated Instruments System
K250520 · OLO
Osteocentric Technologies, Inc.
Orthopedic · 248d
Cleared Oct 17, 2025
StealthStation S8 Spine Software
K251282 · OLO
Medtronic Navigation, Inc.
Orthopedic · 176d
Cleared Oct 10, 2025
TMINI Miniature Robotic System
K252544 · OLO
THINK Surgical, Inc.
Orthopedic · 59d