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
193–216 of 445
Search insights Median review: 95d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
Cleared May 27, 2022
VisAR
K220146 · OLO
Novarad Corporation
Orthopedic · 128d
Cleared May 27, 2022
Spine Guidance Software, Stryker Q Guidance System
K220593 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 87d
Cleared May 25, 2022
Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated...
K221180 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared May 20, 2022
7D Surgical System - Percutaneous Application (7D Flash Frame)
K220522 · OLO
7D Surgical
Orthopedic · 86d
Cleared May 12, 2022
Universal Pilot Guidance Instrument System
K213491 · OLO
Ctl Medical Corporation
Orthopedic · 192d
Cleared May 05, 2022
Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set
K212756 · OLO
Medos International SARL
Orthopedic · 247d
Cleared May 02, 2022
ExactechGPS® System
K213877 · OLO
Blue Ortho
Orthopedic · 140d
Cleared Apr 29, 2022
Camber Spine Navigation System
K220038 · OLO
Camber Spine Technologies
Orthopedic · 114d
Cleared Apr 22, 2022
ROSA® Knee System
K213708 · OLO
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 149d
Cleared Apr 15, 2022
Mako Total Knee Application
K220459 · OLO
Mako Surgical Corp.
Orthopedic · 57d
Cleared Apr 13, 2022
Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument...
K212245 · OLO
Brainlab AG
Orthopedic · 268d
Cleared Mar 31, 2022
NEXXT SPINE NAVIGATION System
K220291 · OLO
Nexxt Spine, LLC
Orthopedic · 58d
Cleared Mar 29, 2022
REAL INTELLIGENCE CORI
K220255 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 57d
Cleared Feb 09, 2022
DeGen Navigated Instrumentation
K213918 · OLO
Degen Medical
Orthopedic · 56d
Cleared Feb 09, 2022
Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™...
K214011 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 49d
Cleared Jan 19, 2022
CoreLink Navigation Instruments
K214059 · OLO
Corelink, LLC
Orthopedic · 23d
Cleared Jan 14, 2022
iASSIST Knee System
K213033 · OLO
Orthosoft D/B/A Zimmer Cas
Orthopedic · 115d
Cleared Jan 11, 2022
360CAS
K213380 · OLO
Kico Knee Innovation Company Pty Limited
Orthopedic · 90d
Cleared Jan 07, 2022
Vital Navigation System
K213720 · OLO
Zimvie (Zimmer Biomet Spine, Inc.)
Orthopedic · 44d
Cleared Jan 06, 2022
ExactechGPS Total Shoulder Application, Equinoxe Planning Software
K213546 · OLO
Blue Ortho
Orthopedic · 59d
Cleared Dec 23, 2021
Integrity Implants Navigated Instruments
K212088 · OLO
Integrity Implants, Inc.
Orthopedic · 170d
Cleared Nov 03, 2021
REAL INTELLIGENCE CORI (CORI)
K212537 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 83d
Cleared Oct 13, 2021
CoreLink Navigation Instruments
K212825 · OLO
Corelink, LLC
Orthopedic · 40d
Cleared Sep 27, 2021
Dark Star Navigation Instrument System
K212028 · OLO
Republic Spine, LLC
Orthopedic · 90d