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
73–96 of 439
Search insights Median review: 97d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
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
Cleared Jul 26, 2024
Spine Navigation System
K233725 · OLO
Medivis, Inc.
Orthopedic · 248d
Cleared Jul 25, 2024
Spine Guidance Software (Version 5.1)
K241171 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 90d
Cleared Jul 24, 2024
“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)
K241130 · OLO
Point Robotics MedTech, Inc.
Orthopedic · 91d
Cleared Jul 12, 2024
TMINI Miniature Robotic System (TMINI 1.1)
K241031 · OLO
THINK Surgical, Inc.
Orthopedic · 88d
Cleared Jul 05, 2024
Anatase Navi Disposable Instrument
K241625 · OLO
Remex Medical Corp.
Orthopedic · 29d
Cleared Jun 17, 2024
CROSSNAV Navigation Enabled Instruments
K233255 · OLO
DePuy Synthes
Orthopedic · 263d