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
73–96 of 445
Search insights Median review: 95d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
Cleared Apr 02, 2025
FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments
K243659 · OLO
SeaSpine Orthopedics Corporation
Orthopedic · 126d
Cleared Mar 24, 2025
Innovasis Navigation Instruments
K250182 · OLO
Innovasis, Inc.
Orthopedic · 61d
Cleared Mar 21, 2025
Consolidated Operating Room Equipment (CORE) 2 Console
K243958 · OLO
Stryker Instruments
Orthopedic · 88d
Cleared Mar 14, 2025
mBôs (Monogram mBôs TKA System)
K242121 · OLO
Monogram Orthopaedics, Inc.
Orthopedic · 238d
Cleared Mar 07, 2025
SPINEART Navigation Instrument System
K242890 · OLO
Spineart SA
Orthopedic · 165d
Cleared Mar 07, 2025
Op.n(TM) Navigation
K242914 · OLO
Ecential Robotics
Orthopedic · 164d
Cleared Mar 05, 2025
Mako Total Hip Application 5.0
K243751 · OLO
Mako Surgical Corp.
Orthopedic · 90d
Cleared Feb 21, 2025
Paradigm System
K243258 · OLO
Proprio, Inc.
Orthopedic · 129d
Cleared Jan 29, 2025
GYDER® Hip System
K243387 · OLO
Gyder Surgical Pty, Ltd.
Orthopedic · 90d
Cleared Jan 10, 2025
NuVasive Pulse System
K243814 · OLO
Globus Medical, Inc.
Orthopedic · 30d
Cleared Jan 06, 2025
TMINI Miniature Robotic System
K243481 · OLO
THINK Surgical, Inc.
Orthopedic · 59d
Cleared Dec 20, 2024
ExcelsiusGPS® Instruments
K243671 · OLO
Globus Medical, Inc.
Orthopedic · 23d
Cleared Dec 13, 2024
Remex Spine Surgery Navigation Instrument
K243560 · OLO
Remex Medical Corp.
Orthopedic · 25d
Cleared Dec 06, 2024
AnyPlus Navigated Instruments System
K243073 · OLO
GS Medical Co., Ltd.
Orthopedic · 70d
Cleared Nov 15, 2024
TMINI Miniature Robotic System
K243285 · OLO
THINK Surgical, Inc.
Orthopedic · 28d
Cleared Nov 07, 2024
Mako Shoulder Application (1.0)
K242373 · OLO
Mako Surgical Corp.
Orthopedic · 90d
Cleared Oct 18, 2024
ROSA® Knee System
K242864 · OLO
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 28d
Cleared Oct 17, 2024
EGPS Navigated Instruments
K240160 · OLO
Astura Medical
Orthopedic · 272d
Cleared Sep 16, 2024
CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays
K241893 · OLO
Medos International SARL
Orthopedic · 80d
Cleared Aug 27, 2024
Q Guidance System
K241517 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 90d
Cleared Aug 23, 2024
TMINI Miniature Robotic System
K242264 · OLO
THINK Surgical, Inc.
Orthopedic · 22d
Cleared Aug 08, 2024
360CAS Knee
K242009 · OLO
Kico Knee Innovation Company Pty, Ltd.
Orthopedic · 29d
Cleared Aug 07, 2024
SPINEART Navigation Instrument System
K241644 · OLO
Spineart SA
Orthopedic · 61d
Cleared Aug 02, 2024
Bendini Cloud Application
K233706 · OLO
Nuvasive
Orthopedic · 256d