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
169–192 of 445
Search insights Median review: 95d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
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
Cleared Dec 09, 2022
SeaSpine 7D Navigation Instruments
K222753 · OLO
SeaSpine Orthopedics Corporation
Orthopedic · 88d
Cleared Oct 28, 2022
Remi Robotic Navigation System
K223070 · OLO
Fusion Robotics, LLC
Orthopedic · 28d
Cleared Oct 27, 2022
Cirq Arm System (2.0)
K222966 · OLO
Brainlab AG
Orthopedic · 30d
Cleared Oct 07, 2022
CUVIS-spine
K222698 · OLO
Curexo, Inc.
Orthopedic · 30d
Cleared Oct 04, 2022
ROSA® Knee System
K221928 · OLO
Orthosoft D/B/A Zimmer Cas
Orthopedic · 95d
Cleared Sep 29, 2022
Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX...
K222383 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 55d
Cleared Aug 30, 2022
Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine &...
K221618 · OLO
Brainlab AG
Orthopedic · 88d
Cleared Aug 19, 2022
REAL INTELLIGENCE CORI
K221224 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 113d
Cleared Aug 09, 2022
“POINT” Kinguide Robotic-Assisted Surgical System
K220241 · OLO
Point Robotics MedTech, Inc.
Orthopedic · 193d
Cleared Aug 05, 2022
Spineology Navigation Instruments
K213876 · OLO
Spineology, Inc.
Orthopedic · 235d
Cleared Jul 27, 2022
Real Intelligence Cori
K220958 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 117d
Cleared Jul 14, 2022
Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and...
K220348 · OLO
Remex Medical Corporation
Orthopedic · 157d
Cleared Jul 14, 2022
E-GPS Navigated Instruments
K220862 · OLO
Precision Spine, Inc.
Orthopedic · 112d
Cleared Jul 07, 2022
SkyWalker Total Knee System
K213873 · OLO
Microport Navibot International, LLC
Orthopedic · 206d
Cleared Jul 06, 2022
ChoiceSpine Navigation System
K220024 · OLO
Choice Spine, LLC
Orthopedic · 182d
Cleared Jul 06, 2022
SURGIVISIO Device
K221028 · OLO
Ecential Robotics
Orthopedic · 90d
Cleared Jun 03, 2022
Knee 3
K220652 · OLO
Brainlab AG
Orthopedic · 88d
Cleared Jun 01, 2022
CoreLink Navigation Instruments
K220973 · OLO
Corelink, LLC
Orthopedic · 58d