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
145–168 of 439
Search insights Median review: 97d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
Cleared Jun 23, 2023
EUROPA™ Navigated Instruments
K230369 · OLO
MiRus, LLC
Orthopedic · 133d
Cleared Jun 22, 2023
CUVIS-spine
K223558 · OLO
Curexo, Inc.
Orthopedic · 206d
Cleared May 26, 2023
CD Horizon™ Spinal System
K231184 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared May 25, 2023
S-COMP Reform® POCT Navigation Instruments
K231229 · OLO
Precision Spine, Inc.
Orthopedic · 27d
Cleared May 05, 2023
Rod Registration Frame
K230989 · OLO
Nu Vasive, Incorporated
Orthopedic · 29d
Cleared May 02, 2023
Excella Navigation Instruments
K223511 · OLO
Innovasis, Inc.
Orthopedic · 161d
Cleared May 02, 2023
CoreLink Navigation Instruments
K230880 · OLO
Corelink, LLC
Orthopedic · 33d
Cleared Apr 25, 2023
TMINI™ Miniature Robotic System
K230202 · OLO
THINK Surgical, Inc.
Orthopedic · 90d
Cleared Apr 21, 2023
Paradigm System
K222291 · OLO
Proprio, Inc.
Orthopedic · 263d
Cleared Apr 21, 2023
Anatase Spine Surgery Navigation System
K230783 · OLO
Remex Medical Corp.
Orthopedic · 30d
Cleared Apr 07, 2023
Mazor X System (Mazor X Stealth Edition)
K230064 · OLO
Mazor Robotics , Ltd.
Orthopedic · 88d
Cleared Mar 29, 2023
ROSA® Knee System
K230243 · OLO
Orthosoft D/B/A Zimmer Cas
Orthopedic · 58d
Cleared Mar 23, 2023
ATEC Lateral Navigation Instruments
K223765 · OLO
Alphatec Spine, Inc.
Orthopedic · 98d
Cleared Mar 13, 2023
Remi Robotic Navigation System
K223350 · OLO
Fusion Robotics, LLC
Orthopedic · 131d
Cleared Mar 08, 2023
PathKeeper System
K222355 · OLO
Pathkeeper Surgical , Ltd.
Orthopedic · 216d
Cleared Feb 22, 2023
Rosa Knee System
K230180 · OLO
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 30d
Cleared Feb 13, 2023
Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software,...
K223767 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 60d
Cleared Jan 31, 2023
Naviswiss Knee
K223351 · OLO
Naviswiss AG
Orthopedic · 90d
Cleared Jan 27, 2023
360CAS
K223927 · OLO
Kico Knee Innovation Company Pty Limited
Orthopedic · 28d
Cleared Jan 20, 2023
Blueprint Mixed Reality system
K222510 · OLO
Tornier S.A.S.
Orthopedic · 154d
Cleared Jan 19, 2023
TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN...
K223108 · OLO
Medos International SARL
Orthopedic · 111d
Cleared Jan 06, 2023
Curiteva Navigation System
K223200 · OLO
Curiteva, Inc.
Orthopedic · 85d
Cleared Dec 22, 2022
VERTICALE® Navigation Instruments
K223649 · OLO
Silony Medical GmbH
Orthopedic · 16d
Cleared Dec 09, 2022
RobPath® Total Hip Application
K220774 · OLO
Hangzhou Lancet Robotics Co., Ltd.
Orthopedic · 268d